<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/NCT03246087</url>
  </required_header>
  <id_info>
    <org_study_id>FWH20170077H</org_study_id>
    <nct_id>NCT03246087</nct_id>
  </id_info>
  <brief_title>Acupuncture for Plantar Fasciosis in the Primary Care Setting</brief_title>
  <official_title>Acupuncture for Plantar Fasciosis in the Primary Care Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mike O'Callaghan Military Hospital</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mike O'Callaghan Military Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the addition of acupuncture to a standard of&#xD;
      care prescribed exercise program is more effective at improving pain and function in adult&#xD;
      patients with plantar fasciosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators are studying whether a specific acupuncture protocol, when added to the&#xD;
      standard of care treatment, can improve pain and function in adults with plantar fasciosis.&#xD;
      Investigators hypothesize that there will be a significant improvement in both pain and&#xD;
      functional outcomes, both acutely and over time, in the experimental group compared to the&#xD;
      control group. Investigators will measure foot pain immediately prior to treatment&#xD;
      (baseline), immediately after the initial treatment and at 2 weeks, 4 weeks, and 3 months.&#xD;
      The Foot Function Index Revised short form will be used during the same intervals to evaluate&#xD;
      foot function. At 3 months, patients in the non-acupuncture group will cross-over into the&#xD;
      acupuncture group if still experiencing pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2017</start_date>
  <completion_date type="Actual">February 13, 2019</completion_date>
  <primary_completion_date type="Actual">February 13, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>NPRS-11</measure>
    <time_frame>90 days</time_frame>
    <description>Numeric Pain Rating Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VAS</measure>
    <time_frame>90 days</time_frame>
    <description>Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FFI-R</measure>
    <time_frame>90 days</time_frame>
    <description>Revised Foot Function Index Short Form</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Plantar Fascitis</condition>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive acupuncture for plantar fasciosis. The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Crossover</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acupunture</intervention_name>
    <description>acupuncture for plantar fasciosis&#xD;
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.</description>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_label>Crossover</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>standard of care home exercise program</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE&#xD;
        IN ORDER TO PARTICIPATE IN THIS STUDY.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Male and female DoD beneficiaries, age 18 years or older, who have been diagnosed with&#xD;
        plantar fasciitis/fasciosis OR Patients meeting criteria of pain in the bottom of the&#xD;
        foot/heel with first steps in the morning &amp; tender to palpation over the medial calcaneal&#xD;
        tubercle (where the plantar fascia inserts). Those with acute and chronic diagnoses will be&#xD;
        included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Absence of leg&#xD;
&#xD;
          -  Active cellulitis of lower extremity&#xD;
&#xD;
          -  Prior surgery for plantar fasciitis&#xD;
&#xD;
          -  Steroid injections in the last 12 weeks for plantar fasciitis; if received in last 12&#xD;
             weeks subjects will be offered to be involved in the study after they have completed a&#xD;
             12 week wash out period.&#xD;
&#xD;
          -  Any regenerative therapy to include proliferation therapy or platelet rich plasma&#xD;
             therapy in the last 12 weeks for plantar fasciitis; if received in last 12 weeks&#xD;
             subject will be offered to be involved in the study after they have completed a 12&#xD;
             week wash out period.&#xD;
&#xD;
          -  Botox injections for plantar fasciitis injections in the last 12 weeks for plantar&#xD;
             fasciitis; if received in last 12 weeks subject will be offered to be involved in the&#xD;
             study after they have completed a 12 week wash out period.&#xD;
&#xD;
          -  Use of anticoagulants&#xD;
&#xD;
          -  If they have every had any prior acupuncture for plantar fasciitis using the defined&#xD;
             KB-2 points&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Cagle, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scott AFB</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlton Covey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nellis AF</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Scott AFB</name>
      <address>
        <city>Belleville</city>
        <state>Illinois</state>
        <zip>62225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mike O'Callaghan Federal Hospital</name>
      <address>
        <city>Nellis Air Force Base</city>
        <state>Nevada</state>
        <zip>89191</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Cotchett MP, Landorf KB, Munteanu SE. Effectiveness of dry needling and injections of myofascial trigger points associated with plantar heel pain: a systematic review. J Foot Ankle Res. 2010 Sep 1;3:18. doi: 10.1186/1757-1146-3-18.</citation>
    <PMID>20807448</PMID>
  </reference>
  <reference>
    <citation>Covey CJ, Mulder MD. Plantar fasciitis: How best to treat? J Fam Pract. 2013 Sep;62(9):466-71.</citation>
    <PMID>24080555</PMID>
  </reference>
  <reference>
    <citation>Glickman-Simon R, Wallace J. Acupuncture for knee osteoarthritis, chasteberry for premenstrual syndrome, probiotics for irritable bowel syndrome, yoga for hypertension, and trigger point dry needling for plantar fasciitis. Explore (NY). 2015 Mar-Apr;11(2):157-61. doi: 10.1016/j.explore.2014.12.009. Epub 2014 Dec 29. No abstract available.</citation>
    <PMID>25682385</PMID>
  </reference>
  <reference>
    <citation>Kumnerddee W, Pattapong N. Efficacy of electro-acupuncture in chronic plantar fasciitis: a randomized controlled trial. Am J Chin Med. 2012;40(6):1167-76. doi: 10.1142/S0192415X12500863.</citation>
    <PMID>23227789</PMID>
  </reference>
  <reference>
    <citation>Li S, Shen T, Liang Y, Zhang Y, Bai B. Miniscalpel-Needle versus Steroid Injection for Plantar Fasciitis: A Randomized Controlled Trial with a 12-Month Follow-Up. Evid Based Complement Alternat Med. 2014;2014:164714. doi: 10.1155/2014/164714. Epub 2014 Jul 8.</citation>
    <PMID>25114704</PMID>
  </reference>
  <reference>
    <citation>Schwartz O, Levinson T, Astman N, Haim L. Attrition due to orthopedic reasons during combat training: rates, types of injuries, and comparison between infantry and noninfantry units. Mil Med. 2014 Aug;179(8):897-900. doi: 10.7205/MILMED-D-13-00567. Erratum In: Mil Med. 2016 Sep;181(9):1165. Mil Med. 2016 Oct;181(10 ):1391.</citation>
    <PMID>25102533</PMID>
  </reference>
  <reference>
    <citation>Owens BD, Wolf JM, Seelig AD, Jacobson IG, Boyko EJ, Smith B, Ryan MA, Gackstetter GD, Smith TC; Millennium Cohort Study Team. Risk Factors for Lower Extremity Tendinopathies in Military Personnel. Orthop J Sports Med. 2013 Jun 11;1(1):2325967113492707. doi: 10.1177/2325967113492707. eCollection 2013 Jan-Jun.</citation>
    <PMID>26535232</PMID>
  </reference>
  <reference>
    <citation>Roy TC. Diagnoses and mechanisms of musculoskeletal injuries in an infantry brigade combat team deployed to Afghanistan evaluated by the brigade physical therapist. Mil Med. 2011 Aug;176(8):903-8. doi: 10.7205/milmed-d-11-00006.</citation>
    <PMID>21882780</PMID>
  </reference>
  <reference>
    <citation>Scher DL, Belmont PJ Jr, Bear R, Mountcastle SB, Orr JD, Owens BD. The incidence of plantar fasciitis in the United States military. J Bone Joint Surg Am. 2009 Dec;91(12):2867-72. doi: 10.2106/JBJS.I.00257.</citation>
    <PMID>19952249</PMID>
  </reference>
  <reference>
    <citation>Thiagarajah AG. How effective is acupuncture for reducing pain due to plantar fasciitis? Singapore Med J. 2017 Feb;58(2):92-97. doi: 10.11622/smedj.2016143. Epub 2016 Aug 16.</citation>
    <PMID>27526703</PMID>
  </reference>
  <reference>
    <citation>Woitzik E, Jacobs C, Wong JJ, Cote P, Shearer HM, Randhawa K, Sutton D, Southerst D, Varatharajan S, Brison RJ, Yu H, van der Velde G, Stern PJ, Taylor-Vaisey A, Stupar M, Mior S, Carroll LJ. The effectiveness of exercise on recovery and clinical outcomes of soft tissue injuries of the leg, ankle, and foot: A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Man Ther. 2015 Oct;20(5):633-45. doi: 10.1016/j.math.2015.03.012. Epub 2015 Mar 28.</citation>
    <PMID>25892707</PMID>
  </reference>
  <reference>
    <citation>Zhang SP, Yip TP, Li QS. Acupuncture treatment for plantar fasciitis: a randomized controlled trial with six months follow-up. Evid Based Complement Alternat Med. 2011;2011:154108. doi: 10.1093/ecam/nep186. Epub 2011 Feb 15.</citation>
    <PMID>19933769</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acupuncture</keyword>
  <keyword>plantar fasiosis</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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03246087
org study id: FWH20170077H
nct id: NCT03246087
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to determine if the addition of acupuncture to a standard of
      care prescribed exercise program is more effective at improving pain and function in adult
      patients with plantar fasciosis.
Investigators are studying whether a specific acupuncture protocol, when added to the
      standard of care treatment, can improve pain and function in adults with plantar fasciosis.
      Investigators hypothesize that there will be a significant improvement in both pain and
      functional outcomes, both acutely and over time, in the experimental group compared to the
      control group. Investigators will measure foot pain immediately prior to treatment
      (baseline), immediately after the initial treatment and at 2 weeks, 4 weeks, and 3 months.
      The Foot Function Index Revised short form will be used during the same intervals to evaluate
      foot function. At 3 months, patients in the non-acupuncture group will cross-over into the
      acupuncture group if still experiencing pain.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: NPRS-11
time frame: 90 days
description: Numeric Pain Rating Scale
measure: VAS
time frame: 90 days
description: Visual Analogue Scale
measure: FFI-R
time frame: 90 days
description: Revised Foot Function Index Short Form
arm group label: Acupuncture
arm group type: Active Comparator
description: Patients will receive acupuncture for plantar fasciosis. The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
arm group label: Standard of Care
arm group type: Experimental
description: The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.
arm group label: Crossover
arm group type: Experimental
description: At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study.
intervention type: Device
intervention name: Acupunture
description: acupuncture for plantar fasciosis
Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.
arm group label: Acupuncture
arm group label: Crossover
intervention type: Other
intervention name: Standard of care
description: standard of care home exercise program
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen Cagle, MD
role: Principal Investigator
affiliation: Scott AFB
last name: Carlton Covey, MD
role: Principal Investigator
affiliation: Nellis AF
facility: 
facility: 
country: United States
citation: Cotchett MP, Landorf KB, Munteanu SE. Effectiveness of dry needling and injections of myofascial trigger points associated with plantar heel pain: a systematic review. J Foot Ankle Res. 2010 Sep 1;3:18. doi: 10.1186/1757-1146-3-18.
PMID: 20807448
citation: Covey CJ, Mulder MD. Plantar fasciitis: How best to treat? J Fam Pract. 2013 Sep;62(9):466-71.
PMID: 24080555
citation: Glickman-Simon R, Wallace J. Acupuncture for knee osteoarthritis, chasteberry for premenstrual syndrome, probiotics for irritable bowel syndrome, yoga for hypertension, and trigger point dry needling for plantar fasciitis. Explore (NY). 2015 Mar-Apr;11(2):157-61. doi: 10.1016/j.explore.2014.12.009. Epub 2014 Dec 29. No abstract available.
PMID: 25682385
citation: Kumnerddee W, Pattapong N. Efficacy of electro-acupuncture in chronic plantar fasciitis: a randomized controlled trial. Am J Chin Med. 2012;40(6):1167-76. doi: 10.1142/S0192415X12500863.
PMID: 23227789
citation: Li S, Shen T, Liang Y, Zhang Y, Bai B. Miniscalpel-Needle versus Steroid Injection for Plantar Fasciitis: A Randomized Controlled Trial with a 12-Month Follow-Up. Evid Based Complement Alternat Med. 2014;2014:164714. doi: 10.1155/2014/164714. Epub 2014 Jul 8.
PMID: 25114704
citation: Schwartz O, Levinson T, Astman N, Haim L. Attrition due to orthopedic reasons during combat training: rates, types of injuries, and comparison between infantry and noninfantry units. Mil Med. 2014 Aug;179(8):897-900. doi: 10.7205/MILMED-D-13-00567. Erratum In: Mil Med. 2016 Sep;181(9):1165. Mil Med. 2016 Oct;181(10 ):1391.
PMID: 25102533
citation: Owens BD, Wolf JM, Seelig AD, Jacobson IG, Boyko EJ, Smith B, Ryan MA, Gackstetter GD, Smith TC; Millennium Cohort Study Team. Risk Factors for Lower Extremity Tendinopathies in Military Personnel. Orthop J Sports Med. 2013 Jun 11;1(1):2325967113492707. doi: 10.1177/2325967113492707. eCollection 2013 Jan-Jun.
PMID: 26535232
citation: Roy TC. Diagnoses and mechanisms of musculoskeletal injuries in an infantry brigade combat team deployed to Afghanistan evaluated by the brigade physical therapist. Mil Med. 2011 Aug;176(8):903-8. doi: 10.7205/milmed-d-11-00006.
PMID: 21882780
citation: Scher DL, Belmont PJ Jr, Bear R, Mountcastle SB, Orr JD, Owens BD. The incidence of plantar fasciitis in the United States military. J Bone Joint Surg Am. 2009 Dec;91(12):2867-72. doi: 10.2106/JBJS.I.00257.
PMID: 19952249
citation: Thiagarajah AG. How effective is acupuncture for reducing pain due to plantar fasciitis? Singapore Med J. 2017 Feb;58(2):92-97. doi: 10.11622/smedj.2016143. Epub 2016 Aug 16.
PMID: 27526703
citation: Woitzik E, Jacobs C, Wong JJ, Cote P, Shearer HM, Randhawa K, Sutton D, Southerst D, Varatharajan S, Brison RJ, Yu H, van der Velde G, Stern PJ, Taylor-Vaisey A, Stupar M, Mior S, Carroll LJ. The effectiveness of exercise on recovery and clinical outcomes of soft tissue injuries of the leg, ankle, and foot: A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Man Ther. 2015 Oct;20(5):633-45. doi: 10.1016/j.math.2015.03.012. Epub 2015 Mar 28.
PMID: 25892707
citation: Zhang SP, Yip TP, Li QS. Acupuncture treatment for plantar fasciitis: a randomized controlled trial with six months follow-up. Evid Based Complement Alternat Med. 2011;2011:154108. doi: 10.1093/ecam/nep186. Epub 2011 Feb 15.
PMID: 19933769
responsible party type: Sponsor
mesh term: Fasciitis
mesh term: Fasciitis, Plantar
sharing ipd: No