MedTrace Logo

Acupuncture for Medial Tibial Stress Syndrome in the Primary Care Setting

NCT03753373 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2021-11-30

No results posted yet for this study

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.

Conditions

  • Medial Tibial Stress Syndrome

Interventions

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.

Sponsors & Collaborators

  • Eglin AFB Regional Hospital

    lead FED

Principal Investigators

  • Julie A Creech, DO · Eglin AFB, United States Air Force

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-11
Primary Completion
2021-11-23
Completion
2021-11-23

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03753373 on ClinicalTrials.gov