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Acupuncture for Medial Tibial Stress Syndrome in the Primary Care Setting

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ClinicalTrials.gov Identifier: NCT03753373
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Eglin AFB Regional Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Medial Tibial Stress Syndrome Other: Acupuncture Other: Home Exercise Program Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture for Medial Tibial Stress Syndrome in the Primary Care Setting: A Randomized Controlled Trial
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture and Home Exercise
Acupuncture plus the prescribed home exercise program
Other: Acupuncture
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).

Other: Home Exercise Program
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.

Active Comparator: Home Exercise Only
The prescribed home exercise program alone
Other: Home Exercise Program
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.




Primary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.


Secondary Outcome Measures :
  1. 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) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

***THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.***

Inclusion Criteria:

  • Male and female DoD beneficiaries, age 18 years or older,
  • Diagnosed with medial tibial stress syndrome (in one or both of their lower extremities) OR subjects meeting criteria of pain in the posteromedial tibia with exercise and direct palpation of the posteromedial tibia. Subjects with acute and chronic diagnoses will be included.

Exclusion Criteria:

  • Pregnant
  • Any of the following in the lower extremity being included into the study:
  • Active cellulitis of lower extremity
  • Tibial stress fracture
  • If they have ever had any prior acupuncture for medial tibial stress syndrome using the defined KB-2 points.
  • Use of anticoagulants
  • Neurologic deficits, to include abnormal sensation, hypo- or hyper-active reflexes, muscle weakness not attributable to pain
  • History of needle-shock with acupuncture

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753373


Contacts
Contact: Amanda J Crawford, BA (702) 653-2113 amanda.j.crawford.ctr@mail.mil
Contact: Jill M Clark, MBA/HCM (702) 653-3298 jill.m.clark15.ctr@mail.mil

Locations
United States, Florida
96th Medical Group Recruiting
Eglin Air Force Base, Florida, United States, 32542
Contact: Amanda J Crawford, BA    702-653-2113    amanda.j.crawford.ctr@mail.mil   
Contact: Jill M Clark, MBA/HCM    (702) 653-3298    jill.m.clark15.ctr@mail.mil   
Principal Investigator: Julie A Creech, DO         
Sponsors and Collaborators
Eglin AFB Regional Hospital
Investigators
Principal Investigator: Julie A Creech, DO Eglin AFB, United States Air Force

Publications:
Responsible Party: Eglin AFB Regional Hospital
ClinicalTrials.gov Identifier: NCT03753373     History of Changes
Other Study ID Numbers: FWH20180168H
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eglin AFB Regional Hospital:
acupuncture
Medial Tibial Stress Syndrome

Additional relevant MeSH terms:
Syndrome
Medial Tibial Stress Syndrome
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Leg Injuries
Wounds and Injuries