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

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupuncture
Prednisolone
Sponsored by
Kuang Tien General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring acupuncture, carpal tunnel syndrome, CTS, steroid, global symptom score (GSS)

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.-

Sites / Locations

  • Kuang Tien General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture group

Steroid group

Arm Description

acupuncture administered in 8 sessions over 4 weeks

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

Outcomes

Primary Outcome Measures

Global symptoms score (GSS)

Secondary Outcome Measures

eletrophysiological parameters

Full Information

First Posted
November 13, 2009
Last Updated
November 16, 2009
Sponsor
Kuang Tien General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01014221
Brief Title
Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial
Official Title
Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kuang Tien General Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
acupuncture, carpal tunnel syndrome, CTS, steroid, global symptom score (GSS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
acupuncture administered in 8 sessions over 4 weeks
Arm Title
Steroid group
Arm Type
Active Comparator
Arm Description
2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
acupuncture administered in 8 sessions over 4 weeks
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily
Primary Outcome Measure Information:
Title
Global symptoms score (GSS)
Time Frame
Baseline, Month 1, 7, and 13
Secondary Outcome Measure Information:
Title
eletrophysiological parameters
Time Frame
baseline, month 1 and 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.-
Facility Information:
Facility Name
Kuang Tien General Hospital
City
Taichung County
ZIP/Postal Code
40705
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
19590482
Citation
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.
Results Reference
result
PubMed Identifier
21111685
Citation
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.
Results Reference
derived

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

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