Treatment Efficacy of OMT for Carpal Tunnel Syndrome

NCT ID: NCT00394043

Last Updated: 2017-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-10-31

Brief 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.

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Osteopathic Manipulative Treatment

A protocol of specific osteopathic manipulative techniques was applied.

Group Type: EXPERIMENTAL

Osteopathic Manipulative Treatment

Intervention Type: PROCEDURE

A protocol of specific Osteopathic manipulative techniques was used.

Placebo ultrasound

Sub-therapeutic ultrasound was applied.

Group Type: PLACEBO_COMPARATOR

Placebo Sub-Therapeutic Ultrasound

Intervention Type: PROCEDURE

Sub-therapeutic ultrasound was applied in a standardized method.

Standard Medical care

Subjects did not receive either study treatment, but continued to receive standard medical care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Osteopathic Manipulative Treatment

A protocol of specific Osteopathic manipulative techniques was used.

Intervention Type: PROCEDURE

Placebo Sub-Therapeutic Ultrasound

Sub-therapeutic ultrasound was applied in a standardized method.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osteopathic Research Center

UNKNOWN

Sponsor Role: collaborator

University of North Texas Health Science Center

OTHER

Sponsor Role: lead

Principal Investigators

Scott T Stoll, D.O., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Osteopathic Research Center University of North Texas Health Science Center

Other Identifiers

1R21AT002303-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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