The aim of this trial study is to assess the short term effects of acupuncture in treatment of mild to moderate carpal tunnel syndrome. The target population is patients with mild to moderate CTS. A total of sixty four patients will be randomly assigned into control group who will receive night splinting, vitamin B1, B6 and sham acupuncture for four weeks, intervention group who will receive acupuncture in 8 sessions over 4 weeks. Acupuncture consists of 8 sessions that were 60 minutes each in duration, administrated over 4 weeks. Global symptom score will be assessed before intervention, 2 weeks and 4 weeks after the intervention. Electrophysiologic studies will be done before and four weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108174242N2
Registration date:2011-09-24, 1390/07/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-24, 1390/07/02
Registrant information
Name
Najmeh Jafari
Name of organization / entity
Isfahan University of Medical Sciences (IUMS)
Country
Iran (Islamic Republic of)
Phone
+98 31 1771 1112
Email address
n_jafari@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-07-05, 1389/04/14
Expected recruitment end date
2011-09-30, 1390/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Acupuncture in Treatment of Carpal Tunnel Syndrome: A Randomized, Blind Controlled Trial
Public title
Acupuncture in Treatment of Carpal Tunnel Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: clinically diagnosed CTS confirmed by the presence of 1 or more of the following standard electrophysiological criteria : 1) prolonged distal motor latency (DML) (abnormal ≥4.2 ms); 2) prolonged antidromic distal sensory latency (DSL) to the second digit (abnormal ≥3.6 ms; 3) prolonged antidromic wrist-palm sensory nerve conduction velocity (W-P SNCV) (W-P SNCV, abnormal <40 ms) (2)
Exclusion criteria: Severe degree CTS, experiencing symptoms less than 3 months, Clinical and electro diagnostic criteria of associated conditions that could mimic CTS or interfere with its evaluation, such as cervical radiculopathy, proximal median neuropathy, or significant polyneuropathy, Evidence of predisposing conditions such as pregnancy, diabetes mellitus, rheumatoid arthritis, hypothyroidism and trauma, Unfavorable experience of acupuncture or bleeding history, Cognitive disorders, Unwillingness to participate in the present study
Age
From 25 years old to 70 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Chancellor, Isfahan University of Medical Sciences
Street address
Hezarjerib street
City
Isfahan
Postal code
Approval date
2010-07-04, 1389/04/13
Ethics committee reference number
389393
Health conditions studied
1
Description of health condition studied
Carpal tunnel Syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
Global symptom score
Timepoint
Before intervention, 2 weeks and 4 weeks after intervention
Method of measurement
Interview
Secondary outcomes
1
Description
Electrophysiologic criteria
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
Electromyogram
Intervention groups
1
Description
Intervention:intervention group will receive a acupuncture in 8 sessions over 4 weeks. (2 sessions per week). Acupuncture was done with 0.25*40 mm size gauge in fixed and classic acupuncture points (PC-7 [Daling], PC-6 [Neiguan]) for each patient.
Category
Treatment - Other
2
Description
Control group will receive night Splinting, vitamin B1 300mg, B6 40 mg and sham acupuncture for four weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Street address
City
Isfahan
2
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research chancellor, Isfahan University of Medical Sciences
Full name of responsible person
Dr Peyman Adibi
Street address
Hezarjerib street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research chancellor, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Community medicine department
Full name of responsible person
Amir Loghmani
Position
Resident
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1771 1112
Fax
Email
a_loghmani@residents.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Physical Medicine and rehabilitation department
Full name of responsible person
Dr Saeid Khosrawi
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Neurology-Electrodiagnosis Center-Alzahra Hospital
City
Isfahan
Postal code
Phone
+98 31 1221 2167
Fax
Email
khosrawi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Community medicine department
Full name of responsible person
Najmeh Jafari
Position
Resident
Other areas of specialty/work
Street address
Isfahan univesity of medical sciences
City
Isfahan
Postal code
Phone
+98 31 1771 1112
Fax
Email
n_jafari@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)