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

NCT01014221 | Completed

• 1 other identifier: 9612
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

acupuncture; carpal tunnel syndrome; CTS; steroid; global symptom score (GSS)

Outcome Measures

Primary Outcomes (1)

• Global symptoms score (GSS)

  Baseline, Month 1, 7, and 13

Secondary Outcomes (1)

• eletrophysiological parameters

  baseline, month 1 and 13

Study Arms (2)

Acupuncture group

EXPERIMENTAL

acupuncture administered in 8 sessions over 4 weeks

Other: Acupuncture

Steroid group

ACTIVE COMPARATOR

2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily

Drug: Prednisolone

Interventions

Acupuncture OTHER

acupuncture administered in 8 sessions over 4 weeks

Acupuncture group

Prednisolone DRUG

2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily

Steroid group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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.-

Sponsors & Collaborators

• Kuang Tien General Hospital: lead

Study Sites (1)

Kuang Tien General Hospital

Taichung County, Taiwan, 40705, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 19590482 RESULT

• Yang CP, Wang NH, Li TC, Hsieh CL, Chang HH, Hwang KL, Ko WS, Chang MH. A randomized clinical trial of acupuncture versus oral steroids for carpal tunnel syndrome: a long-term follow-up. J Pain. 2011 Feb;12(2):272-9. doi: 10.1016/j.jpain.2010.09.001. Epub 2010 Nov 26.

  PMID: 21111685 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Acupuncture Therapy; Prednisolone

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 16, 2009
• Study Start: July 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 17, 2009

Record last verified: 2009-11

Locations

TW (1)