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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
University of North Texas Health Science Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 27, 2006
    Last Updated
    March 14, 2017
    Sponsor
    University of North Texas Health Science Center
    Collaborators
    Osteopathic Research Center
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    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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