Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial
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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 |
- Global symptoms score (GSS) [ Time Frame: Baseline, Month 1, 7, and 13 ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
presence of at least one of the following primary symptoms:
- numbness, tingling pain, or paresthesia in the median nerve distribution;
- precipitation of these symptoms by repetitive hand activities, which could be relieved by resting, rubbing, and shaking the hand; and
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:
- 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);
- severe CTS that had progressed to visible muscle atrophy;
- 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);
- 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;
- 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;
- recent peptic ulcer or history of steroid intolerance;
- prior unpleasant experience with acupuncture or a bleeding diathesis; or
- cognitive impairment interfering with the patient's ability to follow instructions and describe symptoms.-
Contacts and Locations
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 Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate |
Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013