Comparison of short-term efficacy of acupuncture and exercise therapy in patients with mild to moderate CTS.
Design
This is a randomized controlled clinical trial study conducted on 60 patients
Settings and conduct
Imam Hossein Hospital in Tehran
Participants/Inclusion and exclusion criteria
Patients with mild to moderate CTS referring to Imam Hossein Hospital in Tehran in 2016.
Intervention groups
The patients were randomly divided in to 3 equal groups (20 patients in each group; age range, 29-70 years). In the first group only night splint was used for 6 weeks (control), in the second group splint and tendon and nerve gliding exercises (2 times a day for 6 week) were applied, and the third group splint with electroacupuncture was performed in the PC-6 and PC-7 points for 12 sessions of 40- minute duration (2 sessions/week)
Main outcome variables
The score on the Boston Carpal Tunnel Questionnaire (BCTQ) for Functional Status and Symptom Severity (BCTQ FUNCT and SYMPT), parameters of pinch force, grip force, ROM (flexion and extension) and visual analog scale (VAS) score were evaluated at baseline and after the treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180212038693N1
Registration date:2018-04-12, 1397/01/23
Registration timing:retrospective
Last update:2018-04-12, 1397/01/23
Update count:0
Registration date
2018-04-12, 1397/01/23
Registrant information
Name
Amir Rashed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1406
Email address
a.rashed@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-09-22, 1396/06/31
Trial completion date
empty
Scientific title
The comparison of the effectiveness of acupuncture and exercise therapy in patients with carpal tunnel syndrome
Public title
The effectiveness of exercise therapy and acupuncture in carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate disease stage
No severe CST
Lack of extreme limitation upper extremity limbs
No symptoms of atrophy and muscle dystrophy
Lack of other types of peripheral neuropathy
No history of carpal tunnel surgery, or any damage to the median nerve
The absence of autoimmune or inflammatory diseases
No history of using steroid medications
No use of splint or any treatment for CTS
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization (based on ABC)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
District 1, Daneshjou Boulevard
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2016-06-19, 1395/03/30
Ethics committee reference number
IR.SBMU.MSP.REC.1395.152
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
Functional Status and Symptom Severity
Timepoint
At baseline and after the treatment (6 week)
Method of measurement
Boston Carpal Tunnel Questionnaire (BCTQ) for Functional Status and Symptom Severity (BCTQ FUNCT and SYMPT)
2
Description
Pinch and grip force
Timepoint
At baseline and after the treatment
Method of measurement
Using hydraulic dynamometer
3
Description
ROM (flexion and extension)
Timepoint
At baseline and after the treatment
Method of measurement
Inclinometer
4
Description
Pain severty
Timepoint
at baseline and after the treatment
Method of measurement
visual analog scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: splint with electroacupuncture
Category
Treatment - Devices
2
Description
Intervention group: splint and tendon and nerve gliding exercises