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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014221
• Other study ID #: 9612
• Status: Completed
• Phase: N/A
• First received: November 13, 2009
• Last updated: November 16, 2009
• Start date: July 2007
• Est. completion date: September 2009

Study information

• Verified date: November 2009
• Source: Kuang Tien General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: September 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.-

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Taiwan	Kuang Tien General Hospital	Taichung County

Sponsors (1)

Lead Sponsor	Collaborator
Kuang Tien General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Yang CP, Hsieh CL, Wang NH, Li TC, Hwang KL, Yu SC, Chang MH. Acupuncture in patients with carpal tunnel syndrome: A randomized controlled trial. Clin J Pain. 2009 May;25(4):327-33. doi: 10.1097/AJP.0b013e318190511c. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global symptoms score (GSS)		Baseline, Month 1, 7, and 13	No
Secondary	eletrophysiological parameters		baseline, month 1 and 13	No