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Effects of Deep Transverse Friction Massage along with the Nerve Gliding Exercises in the management of Carpal Tunnel Syndrome patients

Protocol summary

Study aim
To determine the effect of deep transverse friction massage along with the nerve gliding exercises in the management of carpal tunnel syndrome patients
Design
A Randomized Clinical Trial with two groups, not a blinded study of 3rd phase with 11 patients in each group, which is 22 in total
Settings and conduct
Mujahid Hospital, Social Security Hospital, District Health Quarter Hospital
Participants/Inclusion and exclusion criteria
positive Phalen's test, positive Tinel test, positive Duncan's test, both genders of patients with unilateral hand, age 20 to 40, moderate pain(4-7), No neurovascular surgery, No neurovascular condition of neck or upper limb, No neurological condition, No musculoskeletal problem of upper quadrant, No myofascial pain syndrome, No upper extremity trauma, No pain with orthopedic condition, No fracture, No post-traumatic stiffness, No osteoarthritis pain, Not pregnant, No diabetes mellitus
Intervention groups
group A: TENS, Nerve gliding exercises, soft tissue massage Group B: TENS, nerve gliding exercises
Main outcome variables
Pain, Wrist ROM, The Grip Strength, Functional Disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240528061934N1
Registration date: 2024-09-21, 1403/06/31
Registration timing: retrospective

Last update: 2024-09-21, 1403/06/31
Update count: 0
Registration date
2024-09-21, 1403/06/31
Registrant information
Name
Aemen Abid
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 322 7796059
Email address
aimenmalik61@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-17, 1402/11/28
Expected recruitment end date
2024-05-30, 1403/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Deep Transverse Friction Massage along with the Nerve Gliding Exercises in the management of Carpal Tunnel Syndrome patients
Public title
Effects of Deep Transverse Friction Massage on Carpal Tunnel Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of Carpal Tunnel Syndrome by Positive Phalen’s test Positive tinel test, Positive Duncan’s test Both gender of patients with unilateral involvement of hand with age 20 to 40. At least moderate pain (4-7), according to VAS scale (60)4. Patients willing to participate in the study Patients willing to participate in the study.
Exclusion criteria:
Patients with neurovascular surgery or neurovascular condition of the neck or upper limb other than carpal tunnel syndrome Patients with Neurological conditions include (cervical radiculopathy cervical myelopathy, musculoskeletal problems of the upper quadrant (such as rheumatoid arthritis, fibromyalgia Myofascial pain syndrome including pain referred to the hand) or recent upper extremity trauma on the affected Side were excluded. Pain with the orthopaedic condition, fractures, post traumatic stiffness of wrist, wrist pain due to osteoarthritis Pregnancy, postoperative scenario of carpal tunnel syndrome, postsurgical wrist numbness and patients with thyroid complications are all conditions that may be associated with carpal tunnel syndrome .6. Diabetic mellitus patients were excluded from the study
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 22
More than 1 sample in each individual
Number of samples in each individual: 11
Eleven
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling was used to allocate patients. The list of individuals was generated through online randomization generator. According to the list patients were assigned into group 1 and group 2
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
Research and Ethics/ Technical committee for the University of Faisalabad
Street address
University Avenue, Faisal Town Canal Road, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Approval date
2024-02-17, 1402/11/28
Ethics committee reference number
TUF/DR/SA/MSPP/2024/420

Health conditions studied

1

Description of health condition studied
Carpal Tunnel Syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
Before intervention and at the end of 6 weeks of intervention
Method of measurement
Visual Analog Scale will be used

2

Description
Wrist ROM
Timepoint
Before intervention and at the end of 6 weeks of intervention
Method of measurement
Goniometer will be used

3

Description
The Grip Strength
Timepoint
Before intervention and at the end of 6 weeks of intervention
Method of measurement
Handheld Dynamometer will be used

Secondary outcomes

1

Description
Functional Disability
Timepoint
Before intervention and at the end of 6 weeks of intervention
Method of measurement
Boston Carpal Tunnel Questionnaire will be used

Intervention groups

1

Description
Intervention group:
Category
Treatment - Devices

2

Description
Intervention group:
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Mujahid Hospital
Full name of responsible person
Maryam Safdar
Street address
P-103 Z Block Madina Town, Green Belt, Susan Road
City
Faisalabad
Postal code
38000
Phone
+92 321 7978088
Email
asst.prof.rehab.689@tuf.edu.pk
Web page address
https://www.mujahidhospital.org.pk/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Maryam Safdar
Street address
University Avenue, Faisal Town Canal Road, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 321 7978088
Email
asst.prof.rehab.689@tuf.edu.pk
Web page address
https://tuf.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
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
The University of Faisalabad
Full name of responsible person
Aemen Abid
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no 310, khayaban colony no.2, Imtiaz shaheed road tipu street, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2026337
Email
aimenmalik61@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Aemen Abid
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no 310, khayaban colony no.2, Imtiaz shaheed road tipu street, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2026337
Email
aimenmalik61@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Aemen Abid
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no 310, khayaban colony no.2, Imtiaz shaheed road tipu street, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2026337
Email
aimenmalik61@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Effects of deep transverse friction massage along with nerve gliding exercises in the management of carpal tunnel syndrome patients
When the data will become available and for how long
starting six months after publication and it will remain available for everyone
To whom data/document is available
this will be available for everyone
Under which criteria data/document could be used
asst.prof.rehab.689@tuf.edu.pk Mobile number 0092 321 7978088
From where data/document is obtainable
aimenmalik61@yahoo.com Mobile number 0092 322 7796059
What processes are involved for a request to access data/document
Any applicant just need to contact for data/file contact through email at aimenmalik61@yahoo.com
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