<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03015116</url>
  </required_header>
  <id_info>
    <org_study_id>M-10548</org_study_id>
    <nct_id>NCT03015116</nct_id>
  </id_info>
  <brief_title>Photobiomodulation for Plantar Fasciitis</brief_title>
  <official_title>Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Landstuhl Regional Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Landstuhl Regional Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND: Plantar fasciitis, a degenerative injury of the connective tissue in the foot,&#xD;
      results in pain-related disability in Service Members and beneficiaries and contributes to&#xD;
      decreased physical activity and excessive healthcare costs. Even if effective, current&#xD;
      treatment protocols may require 6-12 months of therapy to return individuals to pain-free&#xD;
      activity. Photobiomodulation (PBM), or low level laser therapy, uses non-ionizing light to&#xD;
      elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence&#xD;
      supports use of PBM for other degenerative connective tissue conditions, such as Achilles&#xD;
      tendinopathy and epicondylitis. Unfortunately, previous studies of PBM for treatment of&#xD;
      plantar fasciitis lack optimized treatment parameters and therefore have been inconclusive on&#xD;
      its clinical effectiveness.&#xD;
&#xD;
      SPECIFIC AIMS: 1. Establish feasibility of and adherence to a photobiomodulation protocol in&#xD;
      conjunction with and compared to usual care for plantar fasciitis treatment. 2. Assess the&#xD;
      clinical effectiveness of photobiomodulation in conjunction with and compared to usual care&#xD;
      to improve function and decrease pain and in patients. 3. Assess the difference between two&#xD;
      photobiomodulation dose parameters in conjunction with and compared to usual care for plantar&#xD;
      fasciitis treatment.&#xD;
&#xD;
      DESIGN: The investigators will use a prospective randomized controlled trial to meet the aims&#xD;
      of this exploratory study. METHOD: A sample of 114 military healthcare beneficiaries will be&#xD;
      randomly assigned to either usual care, usual care plus PBM lower dose, or usual care plus&#xD;
      PBM higher dose groups. At baseline, during the treatment protocol, and at long term (3 and 6&#xD;
      month) follow-up, measures of foot function and pain will be collected for analysis. The&#xD;
      proposed methods will allow the study team to establish if PBM accelerates recovery compared&#xD;
      to usual care, as well as determining the optimal dose for future trials comparing PBM to&#xD;
      other, more invasive, therapies for plantar fasciitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2017</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Foot and Ankle Ability Measure (FAAM)</measure>
    <time_frame>Baseline, 3 weeks, and 6 weeks</time_frame>
    <description>The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Defense and Veterans Pain Rating Scale (DVPRS)</measure>
    <time_frame>Baseline, 3 weeks, and 6 weeks</time_frame>
    <description>Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Foot and Ankle Ability Measure (FAAM) Long-term</measure>
    <time_frame>3 months and 6 months</time_frame>
    <description>The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Defense and Veterans Pain Rating Scale (DVPRS) Long-term</measure>
    <time_frame>3 months and 6 months</time_frame>
    <description>Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ankle Dorsiflexion</measure>
    <time_frame>% change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeks</time_frame>
    <description>Measures range of motion of ankle in weight-bearing conditions; recorded as distance from great toe to wall at maximal dorsiflexion in centimeters. The percentage of change between timepoints will be calculated for each individual and then compiled per group.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Plantar Fascitis</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will complete 6 weeks of stretching and cryotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PBM 10 Watts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PBM 25 Watts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stretching</intervention_name>
    <description>Daily foot and ankle stretching protocol</description>
    <arm_group_label>PBM 10 Watts</arm_group_label>
    <arm_group_label>PBM 25 Watts</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cryotherapy</intervention_name>
    <description>Daily cryotherapy in conjunction with stretching</description>
    <arm_group_label>PBM 10 Watts</arm_group_label>
    <arm_group_label>PBM 25 Watts</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
    <other_name>Ice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Photobiomodulation Low Power</intervention_name>
    <description>Photobiomodulation treatment with 10W power output</description>
    <arm_group_label>PBM 10 Watts</arm_group_label>
    <other_name>Low Level Laser therapy</other_name>
    <other_name>low level light therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Photobiomodulation High Power</intervention_name>
    <description>Photobiomodulation treatment with 25W power output</description>
    <arm_group_label>PBM 25 Watts</arm_group_label>
    <other_name>Low level laser therapy</other_name>
    <other_name>low level light therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between ages of 18 - 65 years&#xD;
&#xD;
          2. Eligible for care at Landstuhl Regional Medical Center&#xD;
&#xD;
          3. Diagnosis of PF by healthcare provider based on accepted diagnostic criteria&#xD;
&#xD;
          4. Have experienced symptoms of PF for at least 3 months&#xD;
&#xD;
          5. Able to read and understand English language for consent purposes&#xD;
&#xD;
          6. Able to commit to 6 week intervention and 3 and 6 month follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or plan on becoming pregnant during intervention period (Safety of PBM not&#xD;
             established in pregnancy)&#xD;
&#xD;
          2. History of traumatic injury to symptomatic foot/feet&#xD;
&#xD;
          3. Diagnosis of calcaneal fracture&#xD;
&#xD;
          4. Have previously had corticosteroid injections, surgery, or other invasive treatment&#xD;
             for same condition&#xD;
&#xD;
          5. Greater than 15% of calf area covered in tattoos/ink/scarring (Pigment in ink can&#xD;
             absorb light, causing overheating of skin)&#xD;
&#xD;
          6. History of neuropathy or unable to detect changes in skin temperature (increased risk&#xD;
             of skin warming due to inability to detect change)&#xD;
&#xD;
          7. Currently using medications associated with sensitivity to heat or light (e.g.&#xD;
             amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid,&#xD;
             naproxen, piroxicam, tetracycline, thioridazine, voriconazole)(8) Concurrent&#xD;
             participation in another research study addressing pain issue&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ann K Ketz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>LRMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Landstuhl Regional Medical Center</name>
      <address>
        <city>Landstuhl</city>
        <state>APO Ae</state>
        <zip>09180</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <results_first_submitted>February 10, 2020</results_first_submitted>
  <results_first_submitted_qc>September 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 21, 2021</results_first_posted>
  <last_update_submitted>September 18, 2021</last_update_submitted>
  <last_update_submitted_qc>September 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Landstuhl Regional Medical Center</investigator_affiliation>
    <investigator_full_name>Ann Ketz</investigator_full_name>
    <investigator_title>Chief, Center for Nursing Science and Clinical Inquiry</investigator_title>
  </responsible_party>
  <keyword>photobiomodulation</keyword>
  <keyword>plantar fasciitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fasciitis</mesh_term>
    <mesh_term>Fasciitis, Plantar</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03015116/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03015116/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Usual Care</title>
          <description>Participants will complete 6 weeks of stretching and cryotherapy&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching</description>
        </group>
        <group group_id="P2">
          <title>PBM 10 Watts</title>
          <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output</description>
        </group>
        <group group_id="P3">
          <title>PBM 25 Watts</title>
          <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="38"/>
                <participants group_id="P3" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject has New Medical Status</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Usual Care</title>
          <description>Participants will complete 6 weeks of stretching and cryotherapy&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching</description>
        </group>
        <group group_id="B2">
          <title>PBM 10 Watts</title>
          <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output</description>
        </group>
        <group group_id="B3">
          <title>PBM 25 Watts</title>
          <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="38"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="38"/>
            <count group_id="B4" value="114"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African-American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic/Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Underweight (Less than 18.5)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Normal Weight (18.5 - 24.9)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Overweight (25-29.9)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Obese (Greater than or Equal to 30.0)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Months with Plantar Fasciitis or Plantar Heel Pain</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 to 6 Months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7 to 12 Months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>13 to 24 Months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Greater than 24 months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing Data</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fitzpatrick Skin Type</title>
          <description>A numerical schema for skin color based on melanin pigment, which participants self-select. There is no inherent value to the numbers. 1- skin ivory, always freckles, always burns/peels, never tans; 2 - skin fair or pale, usually freckles, burns/peels often, rarely tans; 3 - skin fair to beige, might freckle, burns on occasion, sometimes tans; 4 - skin olive or light brown, doesn't really freckle, burns rarely, tans often; 5 - skin dark brown, rarely freckles, almost never burns, always tans; 6 - skin deeply pigmented dark brown, never freckles, never burns, always tans darkly.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Type I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Type II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Type III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Type IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Type V</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Type VI</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing Data</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Foot and Ankle Ability Measure (FAAM)</title>
        <description>The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome.</description>
        <time_frame>Baseline, 3 weeks, and 6 weeks</time_frame>
        <population>7 withdrew from Usual Care group; 2 each from treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants will complete 6 weeks of stretching and cryotherapy&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching</description>
          </group>
          <group group_id="O2">
            <title>PBM 10 Watts</title>
            <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output</description>
          </group>
          <group group_id="O3">
            <title>PBM 25 Watts</title>
            <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output</description>
          </group>
        </group_list>
        <measure>
          <title>Foot and Ankle Ability Measure (FAAM)</title>
          <description>The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome.</description>
          <population>7 withdrew from Usual Care group; 2 each from treatment groups.</population>
          <units>percentage of total score</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline ADL Subscale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.2" lower_limit="61.2" upper_limit="71.2"/>
                    <measurement group_id="O2" value="72.4" lower_limit="67.3" upper_limit="77.4"/>
                    <measurement group_id="O3" value="69.9" lower_limit="64.8" upper_limit="74.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 ADL Subscale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.3" lower_limit="63.9" upper_limit="74.9"/>
                    <measurement group_id="O2" value="81.4" lower_limit="76.2" upper_limit="86.5"/>
                    <measurement group_id="O3" value="78.5" lower_limit="73.4" upper_limit="83.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 ADL Subscale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.4" lower_limit="65.1" upper_limit="75.7"/>
                    <measurement group_id="O2" value="82.9" lower_limit="77.7" upper_limit="88.0"/>
                    <measurement group_id="O3" value="82.3" lower_limit="77.2" upper_limit="87.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Sports Subscale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.4" lower_limit="39.4" upper_limit="53.3"/>
                    <measurement group_id="O2" value="46.5" lower_limit="39.5" upper_limit="53.5"/>
                    <measurement group_id="O3" value="46.3" lower_limit="39.3" upper_limit="53.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 Sports Subscale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.6" lower_limit="39.2" upper_limit="54.0"/>
                    <measurement group_id="O2" value="62.4" lower_limit="55.3" upper_limit="69.5"/>
                    <measurement group_id="O3" value="62.0" lower_limit="55.1" upper_limit="68.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 Sports Subscale</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.9" lower_limit="46.6" upper_limit="61.1"/>
                    <measurement group_id="O2" value="67.7" lower_limit="60.6" upper_limit="74.4"/>
                    <measurement group_id="O3" value="65.7" lower_limit="58.7" upper_limit="72.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Defense and Veterans Pain Rating Scale (DVPRS)</title>
        <description>Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome.</description>
        <time_frame>Baseline, 3 weeks, and 6 weeks</time_frame>
        <population>7 withdrew from Usual Care group; 2 each from treatment groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants will complete 6 weeks of stretching and cryotherapy&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching</description>
          </group>
          <group group_id="O2">
            <title>PBM 10 Watts</title>
            <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output</description>
          </group>
          <group group_id="O3">
            <title>PBM 25 Watts</title>
            <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output</description>
          </group>
        </group_list>
        <measure>
          <title>Defense and Veterans Pain Rating Scale (DVPRS)</title>
          <description>Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome.</description>
          <population>7 withdrew from Usual Care group; 2 each from treatment groups.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline 24 Hour Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.031" lower_limit="3.215" upper_limit="4.848"/>
                    <measurement group_id="O2" value="4.146" lower_limit="3.505" upper_limit="4.786"/>
                    <measurement group_id="O3" value="3.763" lower_limit="3.110" upper_limit="4.415"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 24 Hour Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.634" lower_limit="2.658" upper_limit="4.610"/>
                    <measurement group_id="O2" value="2.948" lower_limit="2.182" upper_limit="3.714"/>
                    <measurement group_id="O3" value="2.863" lower_limit="2.082" upper_limit="3.644"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 24 Hour Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.652" lower_limit="2.695" upper_limit="6.608"/>
                    <measurement group_id="O2" value="2.61" lower_limit="1.859" upper_limit="3.360"/>
                    <measurement group_id="O3" value="2.943" lower_limit="2.178" upper_limit="3.708"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Activity Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.462" lower_limit="2.516" upper_limit="4.408"/>
                    <measurement group_id="O2" value="3.869" lower_limit="3.169" upper_limit="4.570"/>
                    <measurement group_id="O3" value="3.798" lower_limit="3.018" upper_limit="4.578"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 Activity Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.513" lower_limit="2.522" upper_limit="4.503"/>
                    <measurement group_id="O2" value="2.696" lower_limit="1.962" upper_limit="3.430"/>
                    <measurement group_id="O3" value="2.777" lower_limit="1.960" upper_limit="3.594"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 Activity Interferece</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.555" lower_limit="2.608" upper_limit="4.501"/>
                    <measurement group_id="O2" value="2.244" lower_limit="1.543" upper_limit="2.945"/>
                    <measurement group_id="O3" value="2.736" lower_limit="1.955" upper_limit="3.516"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Sleep Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.857" lower_limit="0.966" upper_limit="2.748"/>
                    <measurement group_id="O2" value="2.548" lower_limit="1.888" upper_limit="3.207"/>
                    <measurement group_id="O3" value="1.667" lower_limit="0.932" upper_limit="2.401"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 Sleep Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.269" lower_limit="1.336" upper_limit="3.202"/>
                    <measurement group_id="O2" value="1.986" lower_limit="1.296" upper_limit="2.677"/>
                    <measurement group_id="O3" value="1.229" lower_limit="0.460" upper_limit="1.998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 Sleep Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.748" lower_limit="0.900" upper_limit="2.596"/>
                    <measurement group_id="O2" value="1.476" lower_limit="0.848" upper_limit="2.104"/>
                    <measurement group_id="O3" value="1.111" lower_limit="0.412" upper_limit="1.811"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Mood Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.496" lower_limit="1.577" upper_limit="3.414"/>
                    <measurement group_id="O2" value="2.363" lower_limit="1.682" upper_limit="3.043"/>
                    <measurement group_id="O3" value="2.164" lower_limit="1.406" upper_limit="2.921"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 Mood Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.630" lower_limit="1.662" upper_limit="3.599"/>
                    <measurement group_id="O2" value="1.530" lower_limit="0.813" upper_limit="2.247"/>
                    <measurement group_id="O3" value="1.589" lower_limit="0.790" upper_limit="2.387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 Mood Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.092" lower_limit="1.212" upper_limit="2.973"/>
                    <measurement group_id="O2" value="1.125" lower_limit="0.473" upper_limit="1.777"/>
                    <measurement group_id="O3" value="1.486" lower_limit="0.760" upper_limit="2.211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Stress Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.471" lower_limit="1.489" upper_limit="3.462"/>
                    <measurement group_id="O2" value="2.358" lower_limit="1.631" upper_limit="3.085"/>
                    <measurement group_id="O3" value="2.215" lower_limit="1.406" upper_limit="3.024"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 Stress Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.504" lower_limit="1.534" upper_limit="3.475"/>
                    <measurement group_id="O2" value="1.433" lower_limit="0.770" upper_limit="2.207"/>
                    <measurement group_id="O3" value="1.646" lower_limit="0.846" upper_limit="2.446"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 Stress Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.345" lower_limit="1.441" upper_limit="3.248"/>
                    <measurement group_id="O2" value="1.031" lower_limit="0.62" upper_limit="1.699"/>
                    <measurement group_id="O3" value="1.450" lower_limit="0.705" upper_limit="2.195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Foot and Ankle Ability Measure (FAAM) Long-term</title>
        <description>The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome.</description>
        <time_frame>3 months and 6 months</time_frame>
        <population>Individuals were lost to follow up at each long term follow up time point. Participants from the UC group completed the study after the 6 week follow-up time point. No data were collected from UC care group for the 3 and 6 month time points, therefore are not included in the 3 and 6 month measures.</population>
        <group_list>
          <group group_id="O1">
            <title>PBM 10 Watts</title>
            <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output</description>
          </group>
          <group group_id="O2">
            <title>PBM 25 Watts</title>
            <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output</description>
          </group>
        </group_list>
        <measure>
          <title>Foot and Ankle Ability Measure (FAAM) Long-term</title>
          <description>The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome.</description>
          <population>Individuals were lost to follow up at each long term follow up time point. Participants from the UC group completed the study after the 6 week follow-up time point. No data were collected from UC care group for the 3 and 6 month time points, therefore are not included in the 3 and 6 month measures.</population>
          <units>percentage of total score</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 Months ADL Subscale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.3" lower_limit="74.6" upper_limit="85.9"/>
                    <measurement group_id="O2" value="81.5" lower_limit="76.1" upper_limit="86.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Months Sports Subscale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.4" lower_limit="53.9" upper_limit="70.9"/>
                    <measurement group_id="O2" value="67.6" lower_limit="59.6" upper_limit="75.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months ADL Subscale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.0" lower_limit="76.1" upper_limit="87.9"/>
                    <measurement group_id="O2" value="82.2" lower_limit="76.7" upper_limit="87.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months Sports Subscale</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.4" lower_limit="56.5" upper_limit="74.3"/>
                    <measurement group_id="O2" value="69.0" lower_limit="60.6" upper_limit="77.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Defense and Veterans Pain Rating Scale (DVPRS) Long-term</title>
        <description>Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome.</description>
        <time_frame>3 months and 6 months</time_frame>
        <population>Individuals were lost to follow up at each long term follow up time point. Participants from the UC group completed the study after the 6 week follow-up time point. No data were collected from UC care group for the 3 and 6 month time points, therefore are not included in the 3 and 6 month measures.</population>
        <group_list>
          <group group_id="O1">
            <title>PBM 10 Watts</title>
            <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output</description>
          </group>
          <group group_id="O2">
            <title>PBM 25 Watts</title>
            <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output</description>
          </group>
        </group_list>
        <measure>
          <title>Defense and Veterans Pain Rating Scale (DVPRS) Long-term</title>
          <description>Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome.</description>
          <population>Individuals were lost to follow up at each long term follow up time point. Participants from the UC group completed the study after the 6 week follow-up time point. No data were collected from UC care group for the 3 and 6 month time points, therefore are not included in the 3 and 6 month measures.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3 24 Hour Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.449" lower_limit="1.688" upper_limit="3.211"/>
                    <measurement group_id="O2" value="1.977" lower_limit="1.315" upper_limit="2.639"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 24 Hour Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.126" lower_limit="1.350" upper_limit="2.901"/>
                    <measurement group_id="O2" value="2.148" lower_limit="1.450" upper_limit="2.847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 Activity Interference</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.583" lower_limit="1.828" upper_limit="3.337"/>
                    <measurement group_id="O2" value="1.995" lower_limit="1.286" upper_limit="2.704"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 Activity Interference</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.326" lower_limit="1.540" upper_limit="3.113"/>
                    <measurement group_id="O2" value="1.818" lower_limit="1.094" upper_limit="2.542"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 Sleep Interference</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.691" lower_limit="0.974" upper_limit="2.409"/>
                    <measurement group_id="O2" value="0.720" lower_limit="0.146" upper_limit="1.294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 Sleep Interference</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.541" lower_limit="0.796" upper_limit="2.287"/>
                    <measurement group_id="O2" value="0.880" lower_limit="0.149" upper_limit="1.294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 Mood Interference</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.770" lower_limit="1.094" upper_limit="2.445"/>
                    <measurement group_id="O2" value="1.034" lower_limit="0.399" upper_limit="1.669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 Mood Interference</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.614" lower_limit="0.910" upper_limit="2.317"/>
                    <measurement group_id="O2" value="1.157" lower_limit="0.509" upper_limit="1.805"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3 Stress Interference</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.174" lower_limit="0.484" upper_limit="1.864"/>
                    <measurement group_id="O2" value="1.040" lower_limit="0.378" upper_limit="1.702"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 Stress Interference</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.391" lower_limit="0.579" upper_limit="2.204"/>
                    <measurement group_id="O2" value="1.040" lower_limit="0.261" upper_limit="1.819"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ankle Dorsiflexion</title>
        <description>Measures range of motion of ankle in weight-bearing conditions; recorded as distance from great toe to wall at maximal dorsiflexion in centimeters. The percentage of change between timepoints will be calculated for each individual and then compiled per group.</description>
        <time_frame>% change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants will complete 6 weeks of stretching and cryotherapy&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching</description>
          </group>
          <group group_id="O2">
            <title>PBM 10 Watts</title>
            <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output</description>
          </group>
          <group group_id="O3">
            <title>PBM 25 Watts</title>
            <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output</description>
          </group>
        </group_list>
        <measure>
          <title>Ankle Dorsiflexion</title>
          <description>Measures range of motion of ankle in weight-bearing conditions; recorded as distance from great toe to wall at maximal dorsiflexion in centimeters. The percentage of change between timepoints will be calculated for each individual and then compiled per group.</description>
          <units>percentage of change over time</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>% Change baseline to 3 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.14" spread="0.029"/>
                    <measurement group_id="O2" value="7.16" spread="0.036"/>
                    <measurement group_id="O3" value="17.24" spread="0.045"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% change week 3 to week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.03" spread="0.037"/>
                    <measurement group_id="O2" value="9.02" spread="0.047"/>
                    <measurement group_id="O3" value="3.86" spread="0.023"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>% change baseline to week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="0.055"/>
                    <measurement group_id="O2" value="13.22" spread="0.043"/>
                    <measurement group_id="O3" value="19.79" spread="0.045"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected during the six weeks of active study treatment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Usual Care</title>
          <description>Participants will complete 6 weeks of stretching and cryotherapy&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching</description>
        </group>
        <group group_id="E2">
          <title>PBM 10 Watts</title>
          <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output</description>
        </group>
        <group group_id="E3">
          <title>PBM 25 Watts</title>
          <description>Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks&#xD;
Stretching: Daily foot and ankle stretching protocol&#xD;
Cryotherapy: Daily cryotherapy in conjunction with stretching&#xD;
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Numbness and Tingling</sub_title>
                <description>Grade 2, probably not related to treatment</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>No sham group to neutralize bias related to intervention; Not able to compare the usual care group to the intervention group in long term follow up.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Ann Kobiela Ketz</name_or_title>
      <organization>Landstuhl Regional Medical Center</organization>
      <phone>8022656263</phone>
      <email>annketz@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03015116
org study id: M-10548
nct id: NCT03015116
lead sponsor: 
has dmc: No
BACKGROUND: Plantar fasciitis, a degenerative injury of the connective tissue in the foot,
      results in pain-related disability in Service Members and beneficiaries and contributes to
      decreased physical activity and excessive healthcare costs. Even if effective, current
      treatment protocols may require 6-12 months of therapy to return individuals to pain-free
      activity. Photobiomodulation (PBM), or low level laser therapy, uses non-ionizing light to
      elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence
      supports use of PBM for other degenerative connective tissue conditions, such as Achilles
      tendinopathy and epicondylitis. Unfortunately, previous studies of PBM for treatment of
      plantar fasciitis lack optimized treatment parameters and therefore have been inconclusive on
      its clinical effectiveness.

      SPECIFIC AIMS: 1. Establish feasibility of and adherence to a photobiomodulation protocol in
      conjunction with and compared to usual care for plantar fasciitis treatment. 2. Assess the
      clinical effectiveness of photobiomodulation in conjunction with and compared to usual care
      to improve function and decrease pain and in patients. 3. Assess the difference between two
      photobiomodulation dose parameters in conjunction with and compared to usual care for plantar
      fasciitis treatment.

      DESIGN: The investigators will use a prospective randomized controlled trial to meet the aims
      of this exploratory study. METHOD: A sample of 114 military healthcare beneficiaries will be
      randomly assigned to either usual care, usual care plus PBM lower dose, or usual care plus
      PBM higher dose groups. At baseline, during the treatment protocol, and at long term (3 and 6
      month) follow-up, measures of foot function and pain will be collected for analysis. The
      proposed methods will allow the study team to establish if PBM accelerates recovery compared
      to usual care, as well as determining the optimal dose for future trials comparing PBM to
      other, more invasive, therapies for plantar fasciitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Foot and Ankle Ability Measure (FAAM)
time frame: Baseline, 3 weeks, and 6 weeks
description: The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome.
measure: Defense and Veterans Pain Rating Scale (DVPRS)
time frame: Baseline, 3 weeks, and 6 weeks
description: Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome.
measure: Foot and Ankle Ability Measure (FAAM) Long-term
time frame: 3 months and 6 months
description: The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome.
measure: Defense and Veterans Pain Rating Scale (DVPRS) Long-term
time frame: 3 months and 6 months
description: Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome.
measure: Ankle Dorsiflexion
time frame: % change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeks
description: Measures range of motion of ankle in weight-bearing conditions; recorded as distance from great toe to wall at maximal dorsiflexion in centimeters. The percentage of change between timepoints will be calculated for each individual and then compiled per group.
arm group label: Usual Care
arm group type: Active Comparator
description: Participants will complete 6 weeks of stretching and cryotherapy
arm group label: PBM 10 Watts
arm group type: Experimental
description: Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks
arm group label: PBM 25 Watts
arm group type: Experimental
description: Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks
intervention type: Other
intervention name: Stretching
description: Daily foot and ankle stretching protocol
arm group label: PBM 10 Watts
arm group label: PBM 25 Watts
arm group label: Usual Care
intervention type: Other
intervention name: Cryotherapy
description: Daily cryotherapy in conjunction with stretching
arm group label: PBM 10 Watts
arm group label: PBM 25 Watts
arm group label: Usual Care
other name: Ice
intervention type: Device
intervention name: Photobiomodulation Low Power
description: Photobiomodulation treatment with 10W power output
arm group label: PBM 10 Watts
other name: Low Level Laser therapy
other name: low level light therapy
intervention type: Device
intervention name: Photobiomodulation High Power
description: Photobiomodulation treatment with 25W power output
arm group label: PBM 25 Watts
other name: Low level laser therapy
other name: low level light therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ann K Ketz, PhD
role: Principal Investigator
affiliation: LRMC
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Landstuhl Regional Medical Center
investigator full name: Ann Ketz
investigator title: Chief, Center for Nursing Science and Clinical Inquiry
mesh term: Fasciitis
mesh term: Fasciitis, Plantar
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: No sham group to neutralize bias related to intervention; Not able to compare the usual care group to the intervention group in long term follow up.
point of contact: 