Treatment Efficacy of OMT for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Osteopathic Manipulative Treatment; Placebo Sub-Therapeutic Ultrasound
Intervention type(s): Procedure; Procedure
Intervention description(s): A protocol of specific Osteopathic manipulative techniques was used.; Sub-therapeutic ultrasound was applied in a standardized method.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Carpal Tunnel Sydrome; Osteopathic Manipulative Treatment; Osteopathic Manipulative Medicine; Physical Medicine