Treatment Efficacy of OMT for Carpal Tunnel Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by University of North Texas Health Science Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Osteopathic Research Center
Information provided by:
University of North Texas Health Science Center
ClinicalTrials.gov Identifier:
NCT00394043
First received: October 27, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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


Condition Intervention Phase
Carpal Tunnel Syndrome
Procedure: Osteopathic Manipulative Treatment
Procedure: Placebo Sub-Therapeutic Ultrasound
Procedure: Standard Medical Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment Efficacy of OMT for Carpal Tunnel Syndrome

Resource links provided by NLM:


Further study details as provided by University of North Texas Health Science Center:

Primary Outcome Measures:
  • Changes in the Median motor and sensory distal latencies.
  • Improvement in the patients'self-reported symptoms and functionality scores.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 138
Study Start Date: October 2006
Estimated Study Completion Date: October 2009
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 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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394043

Contacts
Contact: Scott T Stoll, D.O., Ph.D. 817-735-2114 ORCresearch@hsc.unt.edu

Locations
United States, Texas
Univeristy of North Texas Health Science Center/Osteopathic Research Center Recruiting
Fort Worth, Texas, United States, 76107
Principal Investigator: Scott T Stoll, D.O., Ph.D.         
Sub-Investigator: des Anges Cruser, Ph.D., MPA         
Sub-Investigator: Kendi H Pim, D.O.         
Sponsors and Collaborators
University of North Texas Health Science Center
Osteopathic Research Center
Investigators
Principal Investigator: Scott T Stoll, D.O., Ph.D. Osteopathic Research Center University of North Texas Health Science Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00394043     History of Changes
Other Study ID Numbers: 1R21 AT002303-01A2
Study First Received: October 27, 2006
Last Updated: October 27, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Texas Health Science Center:
Carpal Tunnel Sydrome
Osteopathic Manipulative Treatment
Osteopathic Manipulative Medicine
Physical Medicine

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014