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

This study has been completed.
Sponsor:
Information provided by:
Kuang Tien General Hospital
ClinicalTrials.gov Identifier:
NCT01014221
First received: November 13, 2009
Last updated: November 16, 2009
Last verified: November 2009
  Purpose

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 Intervention
Carpal Tunnel Syndrome
Other: Acupuncture
Drug: Prednisolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Kuang Tien General Hospital:

Primary Outcome Measures:
  • Global symptoms score (GSS) [ Time Frame: Baseline, Month 1, 7, and 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • eletrophysiological parameters [ Time Frame: baseline, month 1 and 13 ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: July 2007
Study Completion Date: September 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.-
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01014221

Locations
Taiwan
Kuang Tien General Hospital
Taichung County, Taiwan, 40705
Sponsors and Collaborators
Kuang Tien General Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yang, chun-pai/ Attending physician of Department of Neurology, Kuang Tien General Hospital
ClinicalTrials.gov Identifier: NCT01014221     History of Changes
Other Study ID Numbers: 9612
Study First Received: November 13, 2009
Last Updated: November 16, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by Kuang Tien General Hospital:
acupuncture
carpal tunnel syndrome
CTS
steroid
global symptom score (GSS)

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Syndrome
Cumulative Trauma Disorders
Disease
Median Neuropathy
Mononeuropathies
Nerve Compression Syndromes
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases
Sprains and Strains
Wounds and Injuries
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 23, 2014