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The Effect of Exercise Therapy with Wrist splint on Pain and Function of Patients with Mild Idiopathic Carpal Tunnel Syndrome

Protocol summary

Study aim
Examining the effect of exercise therapy with splint on the improvement of pain and function compared to wrist splinting in patients with mild idiopathic carpal tunnel syndrome
Design
Clinical trial include control group, parallel, double blind, randomized The study has two groups, treatment group (50 subjects) and control group (50 Subjects) Phase 3 clinical trial
Settings and conduct
Severity of the symptoms and hand function will be assessed by Boston carpal tunnel syndrome questionnaire. Then the Grip and Pinch strength, Two-point discrimination, Phalen, Tinel and Compression test will be assessed. Prefabricated splints will be given to both groups. A tendon and nerve gliding exercise program will prescribe to the patients in the treatment group . The exercise therapy last for six weeks. After the treatment, the patients will re-visit and the tests performed at baseline will be repeated for them.
Participants/Inclusion and exclusion criteria
Subjects over 18 years of olds with complaining of symptoms of CTS , and electrophysiological findings of nerve compression will be included. Patients with history of previous treatment with splint or surgery, any trauma on the hands, neck, and shoulders within three months of the study onset, wrist surgery, pregnancy, diabetes, thyroid disorders, and any findings suggesting conditions that interfere with CTS will be excluded.
Intervention groups
َA prefabricated splints will be given to both groups and the patients in the treatment group will be prescribed a tendon and nerve gliding exercise program. Patients will be asked to exercise three times a day and hold every position for 5 seconds. The exercise therapy will last for six weeks.
Main outcome variables
Severity of the symptoms will be assessed by BCTQ. The secondary outcome measures such as the grip and pinch strength will be assessed by dynamometer and pinch-meter, respectively.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191222045849N2
Registration date: 2020-02-08, 1398/11/19
Registration timing: registered_while_recruiting

Last update: 2020-02-08, 1398/11/19
Update count: 0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Maryam Mirshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8500
Email address
m-mirshahi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-05, 1398/10/15
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Exercise Therapy with Wrist splint on Pain and Function of Patients with Mild Idiopathic Carpal Tunnel Syndrome
Public title
The effect of exercise therapy in Carpal Tunnel Syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Symptoms of CTS (pain, paresthesia in the area of hand innervated by the median nerve) and electrophysiological findings of nerve compression (mild CTS)
Exclusion criteria:
Previous treatment with splint or surgery History of any trauma on the hands, neck, and shoulders within three months of the study onset History of wrist surgery Pregnancy History of diabetes, thyroid disorders Any findings suggesting conditions that interfere with CTS (e g, cervical radiculopathy)
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated to receive either splinting or splinting with exercise . A researcher who not involve in the selection and treatment of patients, prepare and sealed opaque envelopes containing the treatment options. After that, every patient randomly will choose one sealed opaque envelope to determine the type of intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
Except sports medicine specialist who educated patients for correct exercising, other researchers, patients, and a person who analysis the data will be blind to the allocated treatments.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Sina Hospital, Imam Khomeini Ave., Hassan Abad Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2017-02-18, 1395/11/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1720

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
Pain and function
Timepoint
Baseline, at two- and six-week intervals after the intervention
Method of measurement
By Boston Carpal Tunnel Questionnaire

Secondary outcomes

1

Description
Grip strength
Timepoint
Baseline, at two- and six-week intervals after the intervention.
Method of measurement
Dynamometer

2

Description
Pinch strength
Timepoint
Baseline, at two- and six-week intervals after the intervention.
Method of measurement
Pinch meter

Intervention groups

1

Description
Intervention group: Wrist splint with tendon and nerve glide exercise, prefabricated splints (wrist splint, Tynor, India) will wear during the night. In tendon glide exercises, fingers are held in five positions of straight, hook, fist, tabletop, and long fist, respectively. The fingers are in full extension in all these positions. At all stages of this exercise, the wrist is in a neutral position. By doing the nerve glide exercises, the median nerve moves through the wrist and the fingers in six different positions. To do this exercise, the elbows are kept supinated with 90 degrees of flexion and shoulder and neck are in the neutral position. In the 1st state, the wrist is in a neutral position, and the fingers and thumb are in the flexion. In the 2nd state, the wrist is in the neutral position, and the fingers and thumb are in the extension. In the 3rd state, the wrist and fingers are in the extension and the thumb is in a neutral position. Then, the wrist, fingers, and thumb are hold in the extension position. In the next step, maintaining the previous position, the forearm is kept supinated. In the final step, a mild extension is applied to the exercising thumb by the opposite hand. All the above steps are performed respectively. Patients will ask to perform all the exercises three times a day, 10 repeats each time, and hold each position for five seconds.
Category
Rehabilitation

2

Description
Control group: Wrist splint (wrist splint, Tynor, India) during at night
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Maryam Mirshahi
Street address
Sina Hospital, Imam Khomeini Ave., Hassan Abad Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
m-mirshahi@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Sahraian
Street address
Central Building of Tehran University of Medical Sciences،No. 226, Qods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8889 6694
Email
m-mirshahi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Mirshahi
Position
Sports Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sina Hospital, Imam Khomeini Ave., Hassan Abad Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
m-mirshahi@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Mirshahi
Position
Sports Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sina Hospital, Imam Khomeini Ave., Hassan Abad Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
m-mirshahi@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Mirshahi
Position
Sports Medicine Specialist
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sina Hospital, Imam Khomeini Ave., Hassan Abad Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
m-mirshahi@sina.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
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