Medial Tibial Stress Syndrome Clinical Trial
Official title:
Acupuncture for Medial Tibial Stress Syndrome in the Primary Care Setting: A Randomized Controlled Trial
Verified date | November 2021 |
Source | Eglin AFB Regional Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 81 |
Est. completion date | November 23, 2021 |
Est. primary completion date | November 23, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | ***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 |
Country | Name | City | State |
---|---|---|---|
United States | 96th Medical Group | Eglin Air Force Base | Florida |
Lead Sponsor | Collaborator |
---|---|
Eglin AFB Regional Hospital |
United States,
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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. Review. — View 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. — View 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. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pain over time as measured by 11-point numerical pain rating score (NPRS-11) | 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. | Visit 1 (Day 1) Beginning, Visit 1 (Day 1) End, Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12) | |
Primary | Change in pain over time as measured by Pain Disability Index (PDI) | 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. | Visit 1 (Day 1) , Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12) | |
Secondary | Change in Medial Tibial Stress Syndrome (MTSS) Score over time | 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. | Visit 1 (Day 1) , Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12) |
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