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Completed

NCT Number: NCT01014221

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuang Tien General Hospital

Taichung County, Taiwan, 40705

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.-

Treatment and study plan

Acupuncture

Other

acupuncture administered in 8 sessions over 4 weeks

Prednisolone

Drug

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

Primary outcomes

  1. Global symptoms score (GSS)

    Time frame: Baseline, Month 1, 7, and 13

Secondary outcomes

  1. eletrophysiological parameters

    Time frame: baseline, month 1 and 13

Sponsors and collaborators

Lead sponsor

Kuang Tien General Hospital

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 16, 2009
Registry last updated
Nov 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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