<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/NCT03753373</url>
  </required_header>
  <id_info>
    <org_study_id>FWH20180168H</org_study_id>
    <nct_id>NCT03753373</nct_id>
  </id_info>
  <brief_title>Acupuncture for Medial Tibial Stress Syndrome in the Primary Care Setting</brief_title>
  <official_title>Acupuncture for Medial Tibial Stress Syndrome in the Primary Care Setting: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eglin AFB Regional Hospital</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eglin AFB Regional Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators want to investigate whether the KB2 acupuncture protocol is an effective&#xD;
      method for decreasing pain and improving physical function in adult subjects with medial&#xD;
      tibial stress syndrome. The investigators hypothesize that there will be significant&#xD;
      improvement in both the acute and long-term timeframes, with respect to measures of pain and&#xD;
      function. The investigators will measure shin pain immediately prior to treatment (baseline),&#xD;
      immediately after initial treatment, one-, two-, and four-weeks following treatment, then&#xD;
      again at three months post-treatment. Functional status will be evaluated at the above&#xD;
      intervals using the Pain Disability Index. The Medial Tibial Stress Syndrome (MTSS) Score is&#xD;
      a newly developed scoring system for subject-reported outcomes in evaluating treatment of&#xD;
      MTSS, and this will be used to evaluate pain relief and physical functional status at initial&#xD;
      treatment (baseline) and again at the four-week follow-up. If at the four-week follow-up no&#xD;
      significant improvement is noted, subjects in the non-acupuncture treatment group will be&#xD;
      given the option to crossover to another KB2 acupuncture treatment regimen, with follow-up as&#xD;
      previously noted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All of the below items are research-related unless marked as 'standard of care':&#xD;
&#xD;
      Screening Visit:&#xD;
&#xD;
        -  Obtain and document signed Informed Consent document and HIPAA Authorization.&#xD;
&#xD;
        -  Review past medical history in Armed Forces Health Longitudinal Technology Application&#xD;
           (AHLTA) to verify the inclusion/exclusion criteria including previous encounter, vital&#xD;
           signs review, medication list, co-morbidities, demographics, and problems list.&#xD;
&#xD;
        -  Record: Date of birth, age, gender, race, ethnicity, DOD ID#, name of standard of care&#xD;
           medications (over-the-counter and prescription), current email address (to be used for&#xD;
           scheduling), height (in inches), weight (in pounds), tobacco-use status, duration of&#xD;
           current shin splints, history of shin splints, and note any prior acupuncture received.&#xD;
&#xD;
        -  Investigators will ask what the subjects expectations are regarding acupuncture's&#xD;
           effectiveness for medial tibial stress syndrome.&#xD;
&#xD;
        -  If the subject is an active duty member, investigators will ask:&#xD;
&#xD;
             -  Have you or are you currently on a fitness restriction for medial tibial stress&#xD;
                syndrome.&#xD;
&#xD;
             -  If so, what are the dates of the restriction?&#xD;
&#xD;
        -  There are several standard of care treatments and physical therapy options for the&#xD;
           treatment of medial tibial stress syndrome which include physical therapy and a home&#xD;
           exercise program. Investigators will standardize what patients in this study are&#xD;
           receiving by having all subjects follow the standard of care prescribed home exercise&#xD;
           program and discontinue any formal physical therapy when entering this study (regular&#xD;
           physical activity such as exercise is allowed, as tolerated by pain level).&#xD;
&#xD;
      Randomization: Subjects will be randomized into 1 of 2 equal groups, using a random number&#xD;
      generator:&#xD;
&#xD;
        -  Group 1: Acupuncture plus the prescribed home exercise program&#xD;
&#xD;
        -  Group 2: The prescribed home exercise program alone&#xD;
&#xD;
      Encounter 1--Day 1 (may be same day as screening visit):&#xD;
&#xD;
        -  Subjects will be given a study diary to document the number of times they performed the&#xD;
           standard of care prescribed home exercise program. Subjects will be advised to complete&#xD;
           the stretching exercises daily and the strengthening exercises every other day.&#xD;
&#xD;
        -  Self-reported pain severity pre-intervention (0 for no pain to 10 being the worst pain)&#xD;
&#xD;
        -  Research treatment intervention according to their randomization group:&#xD;
&#xD;
             -  Group 1:&#xD;
&#xD;
      Acupuncturist will be given a copy of the Protocol for Needle Insertion. Acupuncture will be&#xD;
      performed. The name of the physician performing the acupuncture and also the number of&#xD;
      acupuncture needles placed for each treatment.&#xD;
&#xD;
      The prescribed home exercise program will be reviewed. o Group 2: The prescribed home&#xD;
      exercise program will be reviewed.&#xD;
&#xD;
        -  Self-reported pain severity post-intervention (0 for no pain to 10 being the worst pain)&#xD;
&#xD;
        -  Administer the Pain Disability Index (PDI), Medial Tibial Stress Syndrome Score (MTSS&#xD;
           Score) electronically&#xD;
&#xD;
        -  Subjects will be instructed to perform the stretching exercises daily and the&#xD;
           strengthening exercises every other day.&#xD;
&#xD;
      Encounter 2-- Week 2 Survey:&#xD;
&#xD;
      • Electronic completion of PDI, MTSS Score, pain scale, and patient reported frequency of&#xD;
      home exercise program diary&#xD;
&#xD;
      Encounter 3-- Week 4 Survey:&#xD;
&#xD;
        -  Electronic completion of PDI, MTSS Score, pain scale, and patient reported frequency of&#xD;
           home exercise program diary.&#xD;
&#xD;
        -  Subjects in the non-acupuncture treatment group, with failure of pain scale to decrease&#xD;
           by 2 points on 0-10 point pain scale, will be given the option to crossover to the&#xD;
           acupuncture treatment group, receive acupuncture, and continue scheduled follow-up at 2,&#xD;
           4, and 12 weeks.&#xD;
&#xD;
      Encounter 4-- Week 12 Survey:&#xD;
&#xD;
        -  Electronic completion of PDI, MTSS Score, pain scale, and patient reported frequency of&#xD;
           home exercise program diary&#xD;
&#xD;
        -  Investigators will ask if the subject's expectations regarding acupuncture's&#xD;
           effectiveness for medial tibial stress syndrome were met.&#xD;
&#xD;
      Acupuncture: For purposes of this study, acupuncture will be considered a research-related&#xD;
      intervention and all acupuncturists performing the procedure will be considered engaged&#xD;
      investigators for research purposes. For this study, all physician acupuncturists are deemed&#xD;
      engaged research investigators, since the acupuncture procedure is research-related for the&#xD;
      study. Unless the acupuncturist is added to the study, they will not be permitted to perform&#xD;
      the acupuncture procedure s on the research subjects. Acupuncture treatments will be&#xD;
      utilizing the KB-2 points with manual manipulation accomplished by vigorously running the&#xD;
      acupuncturists thumb nail up and down the handle until a perceived sensation change is noted&#xD;
      in the subject's posteromedial tibia. A single, sterile 100mm needle will be inserted into&#xD;
      the upper third of the medial tibiofibular ligament, followed by a second needle&#xD;
      approximately 2-4 cm below the second needle. The needles will be manipulated as detailed&#xD;
      above to achieve the sensation change along the posteromedial tibia. The needles will then be&#xD;
      irregularly stimulated over the course of 5-7 minutes. The needles will be removed after the&#xD;
      treatment is complete, which will last approximately 5-10 minutes (standard care).&#xD;
&#xD;
      Acupuncture treatments will be as defined: KB-2 are generally not defined specific points,&#xD;
      but are referred to the placement of the needle into the lateral leg and advanced through the&#xD;
      medial tibiofibular ligament (interosseous membrane). The initial KB-2 point will be placed&#xD;
      in the upper 1/3 of the leg distal to the tibial tuberosity. The second needle will be placed&#xD;
      2-4 cm below the first needle, still within the upper 1/3 of the leg.&#xD;
&#xD;
      This study will follow all FDA requirements for the safe use of these devices.&#xD;
&#xD;
      The acupuncture being performed in this study is a standard acupuncture technique for the&#xD;
      treatment of medial tibial stress syndrome. However, for this study, the research-related&#xD;
      acupuncture procedure being performed is considered research-related. The physicians&#xD;
      performing the treatment are trained in this acupuncture technique and added to the study as&#xD;
      engaged research investigators. The Food and Drug Administration (FDA) regulates acupuncture&#xD;
      needles as a class II medical device, because they are intended for use in the cure,&#xD;
      mitigation, treatment, or prevention of disease in man or are intended to affect the&#xD;
      structure or function of the body of man. The FDA regulates the acupuncture needles (see 21&#xD;
      CFR 880.5580). The needles being used are Hwato 0.30X100mm Acupuncture needles, which are&#xD;
      exempt from premarket notification by the FDA for use in acupuncture and will be used in&#xD;
      accordance with their FDA approved labeling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2019</start_date>
  <completion_date type="Actual">November 23, 2021</completion_date>
  <primary_completion_date type="Actual">November 23, 2021</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>Change in pain over time as measured by 11-point numerical pain rating score (NPRS-11)</measure>
    <time_frame>Visit 1 (Day 1) Beginning, Visit 1 (Day 1) End, Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12)</time_frame>
    <description>The NPRS is a validated segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The common format is a horizontal bar or line.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. &quot;no pain&quot;) to '10' representing the other pain extreme (e.g. &quot;pain as bad as you can imagine&quot; or &quot;worst pain imaginable&quot;). The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pain over time as measured by Pain Disability Index (PDI)</measure>
    <time_frame>Visit 1 (Day 1) , Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12)</time_frame>
    <description>The PDI score is a measure of functional status incorporating the dimensions of family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life support activities. The total of these dimensions provides the PDI score, which has been studied as clinically significant when a decrease of 9 points was observed. A score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which you would normally be involved have been totally disrupted or prevented by the patient's pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Medial Tibial Stress Syndrome (MTSS) Score over time</measure>
    <time_frame>Visit 1 (Day 1) , Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12)</time_frame>
    <description>This a score of patient-related outcome measures. Score ranges from 0 (no limitation) to 10 (full limitation). The MTSS score specifically measures pain experienced along the shin and limitations due to shin pain. For the purpose of this study, we will compare the MTSS score reduction to NPRS-11 and look for a concurrent MTSS score decrease by 2 for clinical significance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Medial Tibial Stress Syndrome</condition>
  <arm_group>
    <arm_group_label>Acupuncture and Home Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acupuncture plus the prescribed home exercise program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home Exercise Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The prescribed home exercise program alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Acupuncture treatments will be utilizing the KB-2 points with manual manipulation accomplished by vigorously running the acupuncturists thumb nail up and down the handle until a perceived sensation change is noted in the subject's posteromedial tibia. A single, sterile 100mm needle will be inserted into the upper third of the medial tibiofibular ligament, followed by a second needle approximately 2-4 cm below the second needle. The needles will be manipulated as detailed above to achieve the sensation change along the posteromedial tibia. The needles will then be irregularly stimulated over the course of 5-7 minutes. The needles will be removed after the treatment is complete, which will last approximately 5-10 minutes (standard care).</description>
    <arm_group_label>Acupuncture and Home Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home Exercise Program</intervention_name>
    <description>Subjects will be given a study diary to document the number of times they performed the standard of care prescribed home exercise program. Subjects will be advised to complete the stretching exercises daily and the strengthening exercises every other day.</description>
    <arm_group_label>Acupuncture and Home Exercise</arm_group_label>
    <arm_group_label>Home Exercise Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        ***THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY&#xD;
        INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.***&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female DoD beneficiaries, age 18 years or older,&#xD;
&#xD;
          -  Diagnosed with medial tibial stress syndrome (in one or both of their lower&#xD;
             extremities) OR subjects meeting criteria of pain in the posteromedial tibia with&#xD;
             exercise and direct palpation of the posteromedial tibia. Subjects with acute and&#xD;
             chronic diagnoses will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Any of the following in the lower extremity being included into the study:&#xD;
&#xD;
          -  Active cellulitis of lower extremity&#xD;
&#xD;
          -  Tibial stress fracture&#xD;
&#xD;
          -  If they have ever had any prior acupuncture for medial tibial stress syndrome using&#xD;
             the defined KB-2 points.&#xD;
&#xD;
          -  Use of anticoagulants&#xD;
&#xD;
          -  Neurologic deficits, to include abnormal sensation, hypo- or hyper-active reflexes,&#xD;
             muscle weakness not attributable to pain&#xD;
&#xD;
          -  History of needle-shock with acupuncture&#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>Julie A Creech, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eglin AFB, United States Air Force</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>96th Medical Group</name>
      <address>
        <city>Eglin Air Force Base</city>
        <state>Florida</state>
        <zip>32542</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Garnock C, Witchalls J, Newman P. Predicting individual risk for medial tibial stress syndrome in navy recruits. J Sci Med Sport. 2018 Jun;21(6):586-590. doi: 10.1016/j.jsams.2017.10.020. Epub 2017 Oct 23.</citation>
    <PMID>29122474</PMID>
  </reference>
  <reference>
    <citation>Winters M, Eskes M, Weir A, Moen MH, Backx FJ, Bakker EW. Treatment of medial tibial stress syndrome: a systematic review. Sports Med. 2013 Dec;43(12):1315-33. doi: 10.1007/s40279-013-0087-0.</citation>
    <PMID>23979968</PMID>
  </reference>
  <reference>
    <citation>Rompe JD, Cacchio A, Furia JP, Maffulli N. Low-energy extracorporeal shock wave therapy as a treatment for medial tibial stress syndrome. Am J Sports Med. 2010 Jan;38(1):125-32. doi: 10.1177/0363546509343804. Epub 2009 Sep 23.</citation>
    <PMID>19776340</PMID>
  </reference>
  <reference>
    <citation>Reshef N, Guelich DR. Medial tibial stress syndrome. Clin Sports Med. 2012 Apr;31(2):273-90. doi: 10.1016/j.csm.2011.09.008.</citation>
    <PMID>22341017</PMID>
  </reference>
  <reference>
    <citation>Soer R, Reneman MF, Vroomen PC, Stegeman P, Coppes MH. Responsiveness and minimal clinically important change of the Pain Disability Index in patients with chronic back pain. Spine (Phila Pa 1976). 2012 Apr 15;37(8):711-5. doi: 10.1097/BRS.0b013e31822c8a7a.</citation>
    <PMID>21796022</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 29, 2021</last_update_submitted>
  <last_update_submitted_qc>November 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acupuncture</keyword>
  <keyword>Medial Tibial Stress Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Medial Tibial Stress Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT03753373
org study id: FWH20180168H
nct id: NCT03753373
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators want to investigate whether the KB2 acupuncture protocol is an effective
      method for decreasing pain and improving physical function in adult subjects with medial
      tibial stress syndrome. The investigators hypothesize that there will be significant
      improvement in both the acute and long-term timeframes, with respect to measures of pain and
      function. The investigators will measure shin pain immediately prior to treatment (baseline),
      immediately after initial treatment, one-, two-, and four-weeks following treatment, then
      again at three months post-treatment. Functional status will be evaluated at the above
      intervals using the Pain Disability Index. The Medial Tibial Stress Syndrome (MTSS) Score is
      a newly developed scoring system for subject-reported outcomes in evaluating treatment of
      MTSS, and this will be used to evaluate pain relief and physical functional status at initial
      treatment (baseline) and again at the four-week follow-up. If at the four-week follow-up no
      significant improvement is noted, subjects in the non-acupuncture treatment group will be
      given the option to crossover to another KB2 acupuncture treatment regimen, with follow-up as
      previously noted.
All of the below items are research-related unless marked as 'standard of care':

      Screening Visit:

        -  Obtain and document signed Informed Consent document and HIPAA Authorization.

        -  Review past medical history in Armed Forces Health Longitudinal Technology Application
           (AHLTA) to verify the inclusion/exclusion criteria including previous encounter, vital
           signs review, medication list, co-morbidities, demographics, and problems list.

        -  Record: Date of birth, age, gender, race, ethnicity, DOD ID#, name of standard of care
           medications (over-the-counter and prescription), current email address (to be used for
           scheduling), height (in inches), weight (in pounds), tobacco-use status, duration of
           current shin splints, history of shin splints, and note any prior acupuncture received.

        -  Investigators will ask what the subjects expectations are regarding acupuncture's
           effectiveness for medial tibial stress syndrome.

        -  If the subject is an active duty member, investigators will ask:

             -  Have you or are you currently on a fitness restriction for medial tibial stress
                syndrome.

             -  If so, what are the dates of the restriction?

        -  There are several standard of care treatments and physical therapy options for the
           treatment of medial tibial stress syndrome which include physical therapy and a home
           exercise program. Investigators will standardize what patients in this study are
           receiving by having all subjects follow the standard of care prescribed home exercise
           program and discontinue any formal physical therapy when entering this study (regular
           physical activity such as exercise is allowed, as tolerated by pain level).

      Randomization: Subjects will be randomized into 1 of 2 equal groups, using a random number
      generator:

        -  Group 1: Acupuncture plus the prescribed home exercise program

        -  Group 2: The prescribed home exercise program alone

      Encounter 1--Day 1 (may be same day as screening visit):

        -  Subjects will be given a study diary to document the number of times they performed the
           standard of care prescribed home exercise program. Subjects will be advised to complete
           the stretching exercises daily and the strengthening exercises every other day.

        -  Self-reported pain severity pre-intervention (0 for no pain to 10 being the worst pain)

        -  Research treatment intervention according to their randomization group:

             -  Group 1:

      Acupuncturist will be given a copy of the Protocol for Needle Insertion. Acupuncture will be
      performed. The name of the physician performing the acupuncture and also the number of
      acupuncture needles placed for each treatment.

      The prescribed home exercise program will be reviewed. o Group 2: The prescribed home
      exercise program will be reviewed.

        -  Self-reported pain severity post-intervention (0 for no pain to 10 being the worst pain)

        -  Administer the Pain Disability Index (PDI), Medial Tibial Stress Syndrome Score (MTSS
           Score) electronically

        -  Subjects will be instructed to perform the stretching exercises daily and the
           strengthening exercises every other day.

      Encounter 2-- Week 2 Survey:

      • Electronic completion of PDI, MTSS Score, pain scale, and patient reported frequency of
      home exercise program diary

      Encounter 3-- Week 4 Survey:

        -  Electronic completion of PDI, MTSS Score, pain scale, and patient reported frequency of
           home exercise program diary.

        -  Subjects in the non-acupuncture treatment group, with failure of pain scale to decrease
           by 2 points on 0-10 point pain scale, will be given the option to crossover to the
           acupuncture treatment group, receive acupuncture, and continue scheduled follow-up at 2,
           4, and 12 weeks.

      Encounter 4-- Week 12 Survey:

        -  Electronic completion of PDI, MTSS Score, pain scale, and patient reported frequency of
           home exercise program diary

        -  Investigators will ask if the subject's expectations regarding acupuncture's
           effectiveness for medial tibial stress syndrome were met.

      Acupuncture: For purposes of this study, acupuncture will be considered a research-related
      intervention and all acupuncturists performing the procedure will be considered engaged
      investigators for research purposes. For this study, all physician acupuncturists are deemed
      engaged research investigators, since the acupuncture procedure is research-related for the
      study. Unless the acupuncturist is added to the study, they will not be permitted to perform
      the acupuncture procedure s on the research subjects. Acupuncture treatments will be
      utilizing the KB-2 points with manual manipulation accomplished by vigorously running the
      acupuncturists thumb nail up and down the handle until a perceived sensation change is noted
      in the subject's posteromedial tibia. A single, sterile 100mm needle will be inserted into
      the upper third of the medial tibiofibular ligament, followed by a second needle
      approximately 2-4 cm below the second needle. The needles will be manipulated as detailed
      above to achieve the sensation change along the posteromedial tibia. The needles will then be
      irregularly stimulated over the course of 5-7 minutes. The needles will be removed after the
      treatment is complete, which will last approximately 5-10 minutes (standard care).

      Acupuncture treatments will be as defined: KB-2 are generally not defined specific points,
      but are referred to the placement of the needle into the lateral leg and advanced through the
      medial tibiofibular ligament (interosseous membrane). The initial KB-2 point will be placed
      in the upper 1/3 of the leg distal to the tibial tuberosity. The second needle will be placed
      2-4 cm below the first needle, still within the upper 1/3 of the leg.

      This study will follow all FDA requirements for the safe use of these devices.

      The acupuncture being performed in this study is a standard acupuncture technique for the
      treatment of medial tibial stress syndrome. However, for this study, the research-related
      acupuncture procedure being performed is considered research-related. The physicians
      performing the treatment are trained in this acupuncture technique and added to the study as
      engaged research investigators. The Food and Drug Administration (FDA) regulates acupuncture
      needles as a class II medical device, because they are intended for use in the cure,
      mitigation, treatment, or prevention of disease in man or are intended to affect the
      structure or function of the body of man. The FDA regulates the acupuncture needles (see 21
      CFR 880.5580). The needles being used are Hwato 0.30X100mm Acupuncture needles, which are
      exempt from premarket notification by the FDA for use in acupuncture and will be used in
      accordance with their FDA approved labeling.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in pain over time as measured by 11-point numerical pain rating score (NPRS-11)
time frame: Visit 1 (Day 1) Beginning, Visit 1 (Day 1) End, Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12)
description: The NPRS is a validated segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The common format is a horizontal bar or line.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion.
measure: Change in pain over time as measured by Pain Disability Index (PDI)
time frame: Visit 1 (Day 1) , Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12)
description: The PDI score is a measure of functional status incorporating the dimensions of family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life support activities. The total of these dimensions provides the PDI score, which has been studied as clinically significant when a decrease of 9 points was observed. A score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which you would normally be involved have been totally disrupted or prevented by the patient's pain.
measure: Change in Medial Tibial Stress Syndrome (MTSS) Score over time
time frame: Visit 1 (Day 1) , Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12)
description: This a score of patient-related outcome measures. Score ranges from 0 (no limitation) to 10 (full limitation). The MTSS score specifically measures pain experienced along the shin and limitations due to shin pain. For the purpose of this study, we will compare the MTSS score reduction to NPRS-11 and look for a concurrent MTSS score decrease by 2 for clinical significance.
arm group label: Acupuncture and Home Exercise
arm group type: Experimental
description: Acupuncture plus the prescribed home exercise program
arm group label: Home Exercise Only
arm group type: Active Comparator
description: The prescribed home exercise program alone
intervention type: Other
intervention name: Acupuncture
description: Acupuncture treatments will be utilizing the KB-2 points with manual manipulation accomplished by vigorously running the acupuncturists thumb nail up and down the handle until a perceived sensation change is noted in the subject's posteromedial tibia. A single, sterile 100mm needle will be inserted into the upper third of the medial tibiofibular ligament, followed by a second needle approximately 2-4 cm below the second needle. The needles will be manipulated as detailed above to achieve the sensation change along the posteromedial tibia. The needles will then be irregularly stimulated over the course of 5-7 minutes. The needles will be removed after the treatment is complete, which will last approximately 5-10 minutes (standard care).
arm group label: Acupuncture and Home Exercise
intervention type: Other
intervention name: Home Exercise Program
description: Subjects will be given a study diary to document the number of times they performed the standard of care prescribed home exercise program. Subjects will be advised to complete the stretching exercises daily and the strengthening exercises every other day.
arm group label: Acupuncture and Home Exercise
arm group label: Home Exercise Only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julie A Creech, DO
role: Principal Investigator
affiliation: Eglin AFB, United States Air Force
facility: 
country: United States
citation: Garnock C, Witchalls J, Newman P. Predicting individual risk for medial tibial stress syndrome in navy recruits. J Sci Med Sport. 2018 Jun;21(6):586-590. doi: 10.1016/j.jsams.2017.10.020. Epub 2017 Oct 23.
PMID: 29122474
citation: Winters M, Eskes M, Weir A, Moen MH, Backx FJ, Bakker EW. Treatment of medial tibial stress syndrome: a systematic review. Sports Med. 2013 Dec;43(12):1315-33. doi: 10.1007/s40279-013-0087-0.
PMID: 23979968
citation: Rompe JD, Cacchio A, Furia JP, Maffulli N. Low-energy extracorporeal shock wave therapy as a treatment for medial tibial stress syndrome. Am J Sports Med. 2010 Jan;38(1):125-32. doi: 10.1177/0363546509343804. Epub 2009 Sep 23.
PMID: 19776340
citation: Reshef N, Guelich DR. Medial tibial stress syndrome. Clin Sports Med. 2012 Apr;31(2):273-90. doi: 10.1016/j.csm.2011.09.008.
PMID: 22341017
citation: Soer R, Reneman MF, Vroomen PC, Stegeman P, Coppes MH. Responsiveness and minimal clinically important change of the Pain Disability Index in patients with chronic back pain. Spine (Phila Pa 1976). 2012 Apr 15;37(8):711-5. doi: 10.1097/BRS.0b013e31822c8a7a.
PMID: 21796022
responsible party type: Sponsor
mesh term: Medial Tibial Stress Syndrome
mesh term: Syndrome