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Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01014221
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : November 17, 2009
Sponsor:
Information provided by:
Kuang Tien General Hospital

Tracking Information
First Submitted Date  ICMJE November 13, 2009
First Posted Date  ICMJE November 16, 2009
Last Update Posted Date November 17, 2009
Study Start Date  ICMJE July 2007
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2009)
Global symptoms score (GSS) [ Time Frame: Baseline, Month 1, 7, and 13 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2009)
eletrophysiological parameters [ Time Frame: baseline, month 1 and 13 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial
Official Title  ICMJE Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial
Brief Summary To investigate the efficacy of acupuncture compared with steroid treatment in patients with mild-to-moderate carpal tunnel syndrome (CTS) as measured by objective changes in nerve conduction studies (NCS) and subjective symptoms assessment in a randomized, controlled study.
Detailed Description A total of 77 consecutive and prospective CTS patients confirmed by NCS were enrolled in the study. Those who had fixed sensory complaint over the median nerve and thenar muscle atrophy were excluded. The CTS patients were randomly divided into 2 treatment arms: (1) 2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily (n =39), and (2)acupuncture administered in 8 sessions over 4 weeks (n=38). A validated standard questionnaire as a subjective measurement was used to rate the 5 major symptoms (pain, numbness, paresthesia,weakness/clumsiness, and nocturnal awakening) on a scale from 0 (no symptoms) to 10 (very severe). The total score in each of the 5 categories was termed the global symptom score (GSS). Patients completed standard questionnaires at baseline and 2 and 4 weeks later. The changes in GSS were analyzed to evaluate the statistical significance. NCS were performed at baseline and repeated at the end of the study to assess improvement. All main analyses used intent-to-treat.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carpal Tunnel Syndrome
Intervention  ICMJE
  • Other: Acupuncture
    acupuncture administered in 8 sessions over 4 weeks
  • Drug: Prednisolone
    2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily
Study Arms  ICMJE
  • Experimental: Acupuncture group
    acupuncture administered in 8 sessions over 4 weeks
    Intervention: Other: Acupuncture
  • Active Comparator: Steroid group
    2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily
    Intervention: Drug: Prednisolone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2009)
77
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

presence of at least one of the following primary symptoms:

  1. numbness, tingling pain, or paresthesia in the median nerve distribution;
  2. precipitation of these symptoms by repetitive hand activities, which could be relieved by resting, rubbing, and shaking the hand; and
  3. nocturnal awakening by such sensory symptoms.- plus the presence of 1 or more of the following standard electrophysiologic criteria:

    • (1) prolonged distal motor latency (DML) to the abductor pollicis brevis (APB)(abnormal Z4.7 ms, stimulation over the wrist, 8 cm proximal to the active electrode);
    • (2) prolonged antidromic distal sensory latency (DSL) to the second digit (abnormal Z3.1 ms; stimulation over the wrist, 14 cm proximal to the active electrode); and
    • (3) prolonged antidromic wrist-palm sensory nerve conduction velocity (W-P SNCV) at a distance of 8 cm (W-P SNCV, abnormal <45 m/s).

Exclusion Criteria:

  1. symptoms occurring less than 3 months before the study or symptoms improving during the 1-month initial observation period (to exclude patients who might have spontaneous resolution of symptoms);
  2. severe CTS that had progressed to visible muscle atrophy;
  3. in our study, mild CTS referred to patients with decreased conduction velocity over the palm-wrist segment and delayed DSL, with normal median SNAP amplitude and CMAP amplitude of the APB. Moderate CTS referred to patients with abnormally delayed DML and DSL with either decreased median SNAP amplitude or decreased CMAP amplitude of the APB muscle. Thus, CTS patients with the presence of either fibrillation potentials or reinnervation on needle EMG in the APB were excluded (to ensure the inclusion of only mildly or moderately affected individuals);
  4. clinical or electrophysiologic evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as cervical radiculopathy, proximal median neuropathy, or significant polyneuropathy;
  5. evidence of obvious underlying causes of CTS such as diabetes mellitus, rheumatoid arthritis, hypothyroidism (acromegaly), pregnancy, alcohol abuse or drug usage (steroids or drugs acting through the central nervous system), use of vibrating machinery, and suspected malignancy or inflammation or autoimmune disease were documented as underlying causes for CTS;
  6. recent peptic ulcer or history of steroid intolerance;
  7. prior unpleasant experience with acupuncture or a bleeding diathesis; or
  8. cognitive impairment interfering with the patient's ability to follow instructions and describe symptoms.-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01014221
Other Study ID Numbers  ICMJE 9612
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yang, chun-pai/ Attending physician of Department of Neurology, Kuang Tien General Hospital
Study Sponsor  ICMJE Kuang Tien General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kuang Tien General Hospital
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP