To assess the effect of exercise rehabilitation on quality of life in patients with carpal tunnel syndrome
Design
This is a before-after clinical trial, in which 30 eligible patients will be enrolled.
Settings and conduct
The eligible patients with carpal tunnel syndrome who will refer to Omid Clinic in Hamadan City during the study period will be enrolled in the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 25 to 65 year
Mild to moderate carpal tunnel syndrome
Exclusion criteria:
Orthopedic disorders
Cognitive disorders
Diabetes
Rheumatoid arthritis
Hyperthyroidism
Using any analgesic drugs
A history of wrist surgery
Pregnancy
Intervention groups
Intervention group:
Exercise rehabilitation for 30 minutes, three times a day, f5 days a week, for 6 weeks
Control group:
In comparison with before intervention
Main outcome variables
Primary outcome:
Assessing the severity of pain
Assessing the severity of the disability
Assessing the mood status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N278
Registration date:2019-05-14, 1398/02/24
Registration timing:registered_while_recruiting
Last update:2019-05-14, 1398/02/24
Update count:0
Registration date
2019-05-14, 1398/02/24
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of exercise rehabilitation on quality of life in patients with carpal tunnel syndrome: a before-after clinical trial
Public title
Effect of exercise rehabilitation on quality of life in patients with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 25 to 65 year
Mild to moderate carpal tunnel syndrome
Exclusion criteria:
Orthopedic disorders
Cognitive disorders
Diabetes
Rheumatoid arthritis
Hyperthyroidism
Using any analgesic drugs
A history of wrist surgery
Pregnancy
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-04-27, 1398/02/07
Ethics committee reference number
IR.UMSHA.REC.1398.020
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
Assessing the severity of pain
Timepoint
Before and 6 weeks after the intervention
Method of measurement
Using visual analog scale (VAS)
2
Description
Assessing the severity of disability
Timepoint
Before and 6 weeks after the intervention
Method of measurement
Through physical examination
3
Description
Assessing the mood status
Timepoint
Before and 6 weeks after the intervention
Method of measurement
Using a standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Exercise rehabilitation for 30 minutes, three times a day, f5 days a week, for 6 weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Clinic in Hamadan City
Full name of responsible person
Amin Kavianifard
Street address
Omid Clinic. Shariati Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Dr.aminkavianifard68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Amin Kavianifard
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Dr.aminkavianifard68@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Rashid Heidari Moghadam
Position
Sport Physiologist
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dr.haidari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available