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

Sponsor

Kuang Tien General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01014221

Collaborator

(none)

Enrollment

Location

Arms

26.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Jul 1, 2007

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Global symptoms score (GSS) [Baseline, Month 1, 7, and 13]

Secondary Outcome Measures

eletrophysiological parameters [baseline, month 1 and 13]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.-