Protocol summary

Study aim
To find the effects of tendon gliding exercises and neurodynamic techniques on two point discrimination in patients with carpal tunnel syndrome (CTS).
Design
Two groups, Single blinded, Randomized Controlled Trial.
Settings and conduct
Riphah College of Rehabilitation & Allied Health Sciences Fatima Memorial Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria Age 20-40 years Gender both male and female Numbness and tingling in the area of the median nerve Positive Phalen’s test Positive Tinel’s sign Pain in the wrist area Exclusion Criteria Prior surgical treatment for carpal tunnel syndrome Tendon sheath inflammation Rheumatoid disease Past trauma to the wrist
Intervention groups
Intervention group A Tendon Gliding Exercises, Intervention group B Neurodynamic Technique
Main outcome variables
Two Point Discrimination, Boston Carpal Tunnel Questionnaire (BCTQ), Disability of Arm, Shoulder and Hand Questionnaire (DASH)

General information

Reason for update
Acronym
ETGENTTPDIPCTS
IRCT registration information
IRCT registration number: IRCT20160901029636N1
Registration date: 2019-11-13, 1398/08/22
Registration timing: registered_while_recruiting

Last update: 2019-11-13, 1398/08/22
Update count: 0
Registration date
2019-11-13, 1398/08/22
Registrant information
Name
Muhmmad Salman Bashir
Name of organization / entity
School of Rehabilitation,Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 919 831 4562
Email address
chistisalman@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-01, 1398/08/10
Expected recruitment end date
2020-01-15, 1398/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFECTS OF TENDON GLIDING EXERCISES AND NEURODYNAMIC TECHNIQUES ON TWO POINT DISCRIMINATION IN PATIENTS WITH CARPAL TUNNEL SYNDROME
Public title
EFFECTS OF TENDON GLIDING EXERCISES AND NEURODYNAMIC TECHNIQUES ON TWO POINT DISCRIMINATION IN PATIENTS WITH CARPAL TUNNEL SYNDROME
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-40 years Gender both male and female Numbness and tingling in the area of the median nerve Paresthesia at night Positive Phalen’s test Positive Tinel’s sign Pain in the wrist area
Exclusion criteria:
Prior surgical treatment for carpal tunnel syndrome Cervical radiculopathy Tendon sheath inflammation Rheumatoid disease Diabetes Pregnancy Past trauma to the wrist Muscular atrophy of the thenar eminence
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Written informed consent will be taken. After enrollment into study, patient will be allocated either to group A or Group B by lottery method. No. of Chits will be equal to total sample size, odd Numbers will be allocated to Group A and even number will be allocated to Group B. Each patient will be requested to draw a chit from the box and after that patient will be recruited into either Group A or Group B
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessor Blind: Data safety will be ensured by assigning Specific Identity numbers and all consent, readings forms will be placed in locker to blind Assessors
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
secretary ethical review committee, Riphah College of Rehabilitation and Allied Health Sciences
Street address
28-M, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore.
City
Lahore
Postal code
54000
Approval date
2019-09-07, 1398/06/16
Ethics committee reference number
Ref. No,RCR & AHS/REC/MS-NMPT/005

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
Two point discrimination
Timepoint
Before treatment and after completing the sessions
Method of measurement
Dellon discriminator tool

Secondary outcomes

1

Description
symptom severity/ functional status, physical functioning
Timepoint
Before and after completing treatment sessions
Method of measurement
Boston Carpal Tunnel Questionnaire (BCTQ), Disability of Arm, sHOULDER and Hand (DASH) Questionnaire

Intervention groups

1

Description
Intervention group A Tendon Gliding Exercises
Category
Treatment - Other

2

Description
Intervention group B Neurodynamic Technique
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Riphah College of Rehabilitation & Allied Health Sciences
Full name of responsible person
Muhammad Salman Bashir
Street address
28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore.
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Web page address

2

Recruitment center
Name of recruitment center
Fatima Memorial Hospital
Full name of responsible person
Dr. Farhia Shah
Street address
Main road, Shadman, Lahore.
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
farhia@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Street address
28-M Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore.
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 4497959
Email
chistisalman@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 4497959
Email
chistisalman@yahoo.com

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
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