Acupuncture for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will look at the effectiveness of acupuncture for treating carpal tunnel syndrome
      (CTS). People who participate in this study will have CTS that has been diagnosed by physical
      examination and neurological testing. We will randomly assign study participants to receive
      one of the three types of acupuncture either once, twice, or three times weekly for a total
      of 6 weeks. Acupuncturists will treat one group of patients with true acupuncture. They will
      give the other two groups of patients one of two alternative acupuncture treatments that do
      not use the true acupuncture points. The patients and evaluators will not know the type of
      acupuncture (True, Alternative 1, or Alternative 2) that is being used. The acupuncturists
      will not communicate with the patients and will not be involved in patient evaluation.
    

Detailed description: 
      This is a randomized, double-blind, controlled trial of acupuncture for carpal tunnel
      syndrome (CTS). The study's aims are: (1) To show that we can develop a "single-blind mute"
      methodology that will enable true and alternative acupuncture to be given in a standardized
      and unbiased fashion. (2) To identify and standardize the most appropriate invasive control
      (alternative) acupuncture points for CTS. (3) To develop a manual of acupuncture methods that
      codifies the techniques of administration of true and alternative points that can be used at
      any site performing a randomized clinical trial for CTS. (4) To demonstrate that patient
      recruitment for and retention in a small, short-term, randomized controlled trial (RCT) of
      acupuncture for CTS is sufficient to justify a full-scale RCT. (5) To determine, in an RCT,
      whether true acupuncture provides meaningful benefit for pain in CTS compared to alternative
      acupuncture and whether the frequency of administration of acupuncture influences the
      outcome.

      The patients and evaluators will be blinded as to the type of acupuncture (True, Alternative
      1, or Alternative 2). The acupuncturists will not be blinded but will be mute
      (noncommunicative to the patients) and will not be involved in patient evaluation. Patients
      will have clinically and electrodiagnostically proven CTS. They will be randomized to receive
      one of the three types of acupuncture either once, twice, or three times weekly for 6 weeks
      total (three by three design). Our aim is to recruit 144 patients for this study. The primary
      outcome measure will be a validated CTS Symptom Severity Scale at 2 weeks after the last
      acupuncture treatment. We will evaluate patients 10 weeks later to determine the durability
      of any improvement from acupuncture. Other outcome measures include subjective symptoms,
      functional status, analgesic consumption, frequency/duration of splinting, and effect on
      median nerve conduction velocity.
    

Intervention name(s): Acupuncture therapy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Carpal tunnel syndrome; Acupuncture; Median nerve; Single-blind mute methodology