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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00000394 |
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.
Condition | Intervention | Phase |
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Carpal Tunnel Syndrome |
Procedure: Acupuncture therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Controlled Trial of Acupuncture for Carpal Tunnel Syndrome |
Estimated Enrollment: | 144 |
Study Start Date: | May 1999 |
Estimated Study Completion Date: | January 2002 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | R01 AR45894, NIAMS-003 |
Study First Received: | November 3, 1999 |
Last Updated: | December 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00000394 |
Health Authority: | United States: Federal Government |
Carpal tunnel syndrome Acupuncture Median nerve Single-blind mute methodology |
Carpal Tunnel Syndrome Roussy Levy hereditary areflexic dystasia Charcot-Marie-Tooth Disease Wounds and Injuries Disorders of Environmental Origin Mononeuropathies Nerve Compression Syndromes |
Tomaculous neuropathy Neuromuscular Diseases Peripheral Nervous System Diseases Hereditary Motor and Sensory Neuropathies Charcot Marie Tooth disease Cumulative Trauma Disorders Sprains and Strains |
Median Neuropathy Pathologic Processes Disease Syndrome Nervous System Diseases |