Treatment Efficacy of OMT for Carpal Tunnel Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women with a self-reported medical diagnosis of unilateral or bilateral CTS, between the ages of 21 and 65 and all races and ethnic groups.
- Median motor nerve distal latency greater than 4.2 ms
- A difference between ipsilateral Median and Ulnar motor nerve distal latency greater than 1.5 ms.
- Median nerve sensory nerve distal latency greater than 2.2 ms
- A difference between Median and Ulnar sensory nerve peak distal latency greater than 0.2 ms
Exclusion Criteria:
- severe CTS that has progressed to muscle atrophy
- pregnancy
- previous wrist surgery on the wrist to be studied
- systemic disease or condition including but not limited to diabetes mellitus, thyroid disorders, rheumatoid disorders, Paget's bone disease, gout, myxedema, multiple myeloma, acromegaly, hepatic disease, dialysis patients, or other diseases or conditions in which peripheral neuropathies are common.
- secondary cause of CTS such as a ganglion cyst, mass, or an accessory muscle shown by an MRI exam of the wrist.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Osteopathic Manipulative Treatment
A protocol of specific osteopathic manipulative techniques was applied.
|
A protocol of specific Osteopathic manipulative techniques was used.
|
|
Placebo Comparator: Placebo ultrasound
Sub-therapeutic ultrasound was applied.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Changes in the Median motor and sensory distal latencies.
|
|
Improvement in the patients'self-reported symptoms and functionality scores.
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
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.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Scott T Stoll, D.O., Ph.D., Osteopathic Research Center University of North Texas Health Science Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21AT002303-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.