Treatment Efficacy of OMT for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Treatment Efficacy of OMT for Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394043
• Other study ID #: 1R21AT002303-01A2
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2006
• Last updated: March 14, 2017
• Start date: October 2006
• Est. completion date: October 2009

Study information

• Verified date: March 2017
• Source: University of North Texas Health Science Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigated whether an eight-week regimen of osteopathic manipulative treatment would have immediate and lasting positive effects on the symptoms, functional limitation and physiologic impairment associated with Carpal Tunnel Syndrome.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• Osteopathic Manipulative Treatment
A protocol of specific Osteopathic manipulative techniques was used.
• Placebo Sub-Therapeutic Ultrasound
Sub-therapeutic ultrasound was applied in a standardized method.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of North Texas Health Science Center	Osteopathic Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Median motor and sensory distal latencies.
Primary	Improvement in the patients'self-reported symptoms and functionality scores.
Secondary	Strength measured with one grip and three pinch strength tests.
Secondary	Changes in sensation as measured by Current Perceptual Threshold.
Secondary	Changes in the transverse and anterior/posterior interior diameters and cross-sectional areas of the carpal tunnel.
Secondary	Carpal tunnel edema.