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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. Identifier: NCT01014221
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : November 17, 2009
Information provided by:
Kuang Tien General Hospital

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Other: Acupuncture Drug: Prednisolone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial
Study Start Date : July 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: Acupuncture group
acupuncture administered in 8 sessions over 4 weeks
Other: Acupuncture
acupuncture administered in 8 sessions over 4 weeks

Active Comparator: Steroid group
2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily
Drug: Prednisolone
2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily

Primary Outcome Measures :
  1. Global symptoms score (GSS) [ Time Frame: Baseline, Month 1, 7, and 13 ]

Secondary Outcome Measures :
  1. eletrophysiological parameters [ Time Frame: baseline, month 1 and 13 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01014221

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Kuang Tien General Hospital
Taichung County, Taiwan, 40705
Sponsors and Collaborators
Kuang Tien General Hospital
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yang, chun-pai/ Attending physician of Department of Neurology, Kuang Tien General Hospital Identifier: NCT01014221    
Other Study ID Numbers: 9612
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: November 17, 2009
Last Verified: November 2009
Keywords provided by Kuang Tien General Hospital:
carpal tunnel syndrome
global symptom score (GSS)
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Pathologic Processes
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents