Treatment Efficacy of OMT for Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment
Placebo Sub-Therapeutic Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Sydrome, Osteopathic Manipulative Treatment, Osteopathic Manipulative Medicine, Physical Medicine
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Osteopathic Manipulative Treatment
Placebo ultrasound
Standard Medical care
Arm Description
A protocol of specific osteopathic manipulative techniques was applied.
Sub-therapeutic ultrasound was applied.
Subjects did not receive either study treatment, but continued to receive standard medical care.
Outcomes
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.
Full Information
NCT ID
NCT00394043
First Posted
October 27, 2006
Last Updated
March 14, 2017
Sponsor
University of North Texas Health Science Center
Collaborators
Osteopathic Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00394043
Brief Title
Treatment Efficacy of OMT for Carpal Tunnel Syndrome
Official Title
Treatment Efficacy of OMT for Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of North Texas Health Science Center
Collaborators
Osteopathic Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal Tunnel Sydrome, Osteopathic Manipulative Treatment, Osteopathic Manipulative Medicine, Physical Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Osteopathic Manipulative Treatment
Arm Type
Experimental
Arm Description
A protocol of specific osteopathic manipulative techniques was applied.
Arm Title
Placebo ultrasound
Arm Type
Placebo Comparator
Arm Description
Sub-therapeutic ultrasound was applied.
Arm Title
Standard Medical care
Arm Type
No Intervention
Arm Description
Subjects did not receive either study treatment, but continued to receive standard medical care.
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manipulative Treatment
Intervention Description
A protocol of specific Osteopathic manipulative techniques was used.
Intervention Type
Procedure
Intervention Name(s)
Placebo Sub-Therapeutic Ultrasound
Intervention Description
Sub-therapeutic ultrasound was applied in a standardized method.
Primary Outcome Measure Information:
Title
Changes in the Median motor and sensory distal latencies.
Title
Improvement in the patients'self-reported symptoms and functionality scores.
Secondary Outcome Measure Information:
Title
Strength measured with one grip and three pinch strength tests.
Title
Changes in sensation as measured by Current Perceptual Threshold.
Title
Changes in the transverse and anterior/posterior interior diameters and cross-sectional areas of the carpal tunnel.
Title
Carpal tunnel edema.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott T Stoll, D.O., Ph.D.
Organizational Affiliation
Osteopathic Research Center University of North Texas Health Science Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Treatment Efficacy of OMT for Carpal Tunnel Syndrome
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