Treatment Efficacy of OMT for Carpal Tunnel Syndrome
|ClinicalTrials.gov Identifier: NCT00394043|
Recruitment Status : Completed
First Posted : October 31, 2006
Last Update Posted : March 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome||Procedure: Osteopathic Manipulative Treatment Procedure: Placebo Sub-Therapeutic Ultrasound||Phase 2|
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 was to evaluate the efficacy of a conservative, manual medicine treatment as an adjunctive therapy to standard care for CTS. This pilot study utilized 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 would 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 were 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 were: 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 demonstrated 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 was expected that a significantly greater number of subjects in the OMT adjunctive treatment group would achieve the effective change in nerve latency compared to the other two treatment groups. It was also expected that the OMT adjunctive treatment group would have greater improvement of all physiological and clinical outcome measures than the other two groups.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Treatment Efficacy of OMT for Carpal Tunnel Syndrome|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Experimental: Osteopathic Manipulative Treatment
A protocol of specific osteopathic manipulative techniques was applied.
Procedure: Osteopathic Manipulative Treatment
A protocol of specific Osteopathic manipulative techniques was used.
Placebo Comparator: Placebo ultrasound
Sub-therapeutic ultrasound was applied.
Procedure: Placebo Sub-Therapeutic Ultrasound
Sub-therapeutic ultrasound was applied in a standardized method.
No Intervention: Standard Medical care
Subjects did not receive either study treatment, but continued to receive standard medical care.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394043
|Principal Investigator:||Scott T Stoll, D.O., Ph.D.||Osteopathic Research Center University of North Texas Health Science Center|