To assess the effect of self-stretching on the clinical and electrophysiology symptoms of patients with carpal tunnel syndrome
Design
This is a Phase III randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Besat Hospital in Hamadan city, involving 96 eligible patients with carpal tunnel syndrome. The patients will be randomly assigned to the intervention and control groups through the block randomization. However, it should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 90 years
Carpal tunnel syndrome
Exclusion criteria:
Neuropathic disorders
History of surgery or trauma to the wrist
Intervention groups
Intervention group:
Routine treatment plus self-stretching exercises at home for 30 seconds 4 times a day for 6 weeks
Control group:
Routine treatment plus sham stretching movement at home for 30 seconds 4 times a day for 6 weeks
Main outcome variables
Primary outcome:
Average pain intensity, sensory disorder of the fingers, amplitude and sensory and motor latency of the median nerve, clinical symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N511
Registration date:2024-05-07, 1403/02/18
Registration timing:prospective
Last update:2024-05-07, 1403/02/18
Update count:0
Registration date
2024-05-07, 1403/02/18
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
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self-stretching on the clinical and electrophysiology symptoms of patients with carpal tunnel syndrome: A randomized clinical trial
Public title
Effect of self-stretching on the clinical and electrophysiology symptoms of patients with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 90 years
Carpal tunnel syndrome
Exclusion criteria:
Neuropathic disorders
History of surgery or trauma to the wrist
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2024-04-20, 1403/02/01
Ethics committee reference number
IR.UMSHA.REC.1403.032
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
Average pain intensity
Timepoint
Before the intervention and 6 weeks later
Method of measurement
Using the visual analog scale (VAS)
2
Description
Sensory disorder of the fingers
Timepoint
Before the intervention and 6 weeks later
Method of measurement
Using nerve and muscle tape
3
Description
Amplitude and sensory and motor latency of the median nerve
Timepoint
Before intervention and 6 weeks later
Method of measurement
Using nerve and muscle tape
4
Description
Clinical symptoms
Timepoint
Before the intervention and 6 weeks later
Method of measurement
Using the Boston Clinical Criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus self-stretching exercises at home for 30 seconds 4 times a day for 6 weeks (the patient should stand against a wall or a vertical surface at a right angle with the body completely parallel to the vertical surface while the elbow is fully extended, abduct the upper body straight and extended in front of the trunk so that the angle between the arm and the trunk reaches 90 degrees. The distance between the patient and the opposite surface should be equal to the distance from the shoulder to the wrist, and the wrist should be extended to 90 degrees so that the palm and fingers are on a flat surface. Then the patient hyperextends the thumb and thenar muscles towards himself and repeats this for 30 seconds each time)
Category
Other
2
Description
Control group: Routine treatment plus sham stretching movement at home for 30 seconds 4 times a day for 6 weeks (sham stretching movement is completely ineffective in the treatment of carpal tunnel syndrome. The patient should hold the affected hand from the forearm in front of their face in supine position, then the non-affected hand should put pressure on the place where the nerve passes in the wrist with the thumb)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Dr Alireza Sharifi
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
alirezamed1993@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, 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
Dr Alireza Sharifi
Position
Resident of Neurology
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
alirezamed1993@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Shahir Mazaheri
Position
Neurologist
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sh.mazaheri@umsha.ac.ir
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, 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