NCT00000394

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 1999

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
Last Updated

May 15, 2013

Status Verified

June 1, 2000

First QC Date

November 3, 1999

Last Update Submit

May 14, 2013

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal tunnel syndromeAcupunctureMedian nerveSingle-blind mute methodology

Interventions

Acupuncture therapyPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hand or wrist pain combined with parathesias or numbness in any or all fingers, predominating in a median nerve distribution, and especially occurring at night
  • Symptoms unresponsive or poorly responsive to standard conservative therapy (wrist splints, analgesics, nonsteroidal anti-inflammatory drugs)
  • Electrodiagnostic evidence of distal median neuropathy compatible with carpal tunnel syndrome (to be confirmed at study site)
  • Symptoms present for at least 3 months
  • No prior treatment with acupuncture for carpal tunnel syndrome

You may not qualify if:

  • Evidence of pronounced abductor pollicis weakness or significant thenar wasting (probable candidate for carpal tunnel surgery)
  • Prior carpal tunnel surgery on affected side
  • Use of narcotic analgesia
  • History of wrist or hand fracture on the symptomatic limb
  • Current pregnancy or less than 3 months postpartum
  • Corticosteroid injection into the carpal tunnel within 3 months
  • History of generalized peripheral neuropathy or clinical or electrodiagnostic evidence of generalized polyneuropathy or mononeuropathy multiplex
  • History of other neurologic disorders which may cause confusion with the diagnosis of carpal tunnel syndrome, including but not limited to stroke, cervical radiculopathy, myelopathy, subdural hematoma, brain tumor
  • Inflammatory articular disease or tendinitis of the hand or wrist by history or physical examination
  • Insulin-dependent diabetes mellitus
  • Clinical hypothyroidism
  • Chronic renal failure or renal dialysis or forearm fistulae
  • Other disorder known to predispose to carpal tunnel syndrome including acromegaly, multiple myeloma, amyloidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Arthur Weinstein, M.D.

    The George Washington University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

May 1, 1999

Study Completion

January 1, 2002

Last Updated

May 15, 2013

Record last verified: 2000-06