Treatment Efficacy of OMT for Carpal Tunnel Syndrome
Recruitment status was: Recruiting
Carpal Tunnel Syndrome
Procedure: Osteopathic Manipulative Treatment
Procedure: Placebo Sub-Therapeutic Ultrasound
Procedure: Standard Medical Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Treatment Efficacy of OMT for Carpal Tunnel Syndrome|
- Changes in the Median motor and sensory distal latencies.
- Improvement in the patients'self-reported symptoms and functionality scores.
- Strength measured with one grip and three pinch strength tests.
- Changes in sensation as measured by Current Perceptual Threshold.
- Changes in the transverse and anterior/posterior interior diameters and cross-sectional areas of the carpal tunnel.
- Carpal tunnel edema.
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||October 2009|
The incidence of Carpal Tunnel Syndrome (CTS) in adults in the U.S. ranges from 15-20% depending on the study, and costs over one billion dollars annually in medical care. Surgery for CTS accounts for much of these costs with up to one third of these patients experiencing re-occurrence of symptoms post-operatively.
The overall goal for this proposed exploratory clinical trial is to evaluate the efficacy of a conservative, manual medicine treatment as an adjunctive therapy to standard care for CTS. This pilot study utilizes a prospective, randomized, placebo-controlled clinical trial methodology to examine whether an eight week treatment regimen of osteopathic manipulative treatment (OMT) when used adjunctively to standard therapy will have immediate and lasting positive effects on the symptoms, functional limitations, and physiologic impairment associated with CTS.
Male and female subjects between the ages of 20 and 65 who meet electro-physiologic and symptom/functional inclusion criteria will be randomly assigned to one of three study groups, all of which will continue standard medical care with their treating physician/provider; (i) OMT plus standard medical care; (ii) placebo (sub-therapeutic ultrasound) plus standard medical care; and (iii) standard medical care only (no-treat).
Outcome measures are: 1. Median and Ulnar motor and sensory nerve conduction amplitudes and distal latencies, 2. Symptoms and Functional status, 3. Strength, 4. Sensation, 5. Interior dimensions of the carpal tunnel, and 6. Quantification (signal intensity by MRI) of water (edema) in the Median nerve and carpal tunnel. Placebo potency and blinding success will be evaluated. A preliminary investigation demonstrates our ability to recruit subjects and measure these outcomes. Power analysis based upon a decrease in the mean median motor nerve distal latency of 30% identified a minimum number of 42 subjects per treatment group.
It is expected that a significantly greater number of subjects in the OMT adjunctive treatment group will achieve the effective change in nerve latency compared to the other two treatment groups. It is also expected that the OMT adjunctive treatment group will have greater improvement of all physiological and clinical outcome measures than the other two groups. It is anticipated that the findings of this preliminary clinical trial will provide a basis for the development of a multi-center clinical trial to compare the outcomes of conservative non-surgical manual medicine treatments with the outcomes of surgical treatments of CTS.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394043
|United States, Texas|
|Univeristy of North Texas Health Science Center/Osteopathic Research Center|
|Fort Worth, Texas, United States, 76107|
|Principal Investigator:||Scott T Stoll, D.O., Ph.D.||Osteopathic Research Center University of North Texas Health Science Center|