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Comparison of Flexor Retinaculum Stretch and Carpal Mobilizations in Patients With Carpal Tunnel Syndrome.

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Carpal bone mobilization
Flexor retinaculum stretch
Carpal bone mobilization and flexor retinaculum stretch
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring median neuropathy, thenar muscle atrophy, compression neuropathy, flexor retinaculum

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Females Age between 18-40 years Unilateral CTS Already diagnosed patients of CTS. Exclusion Criteria: Fracture of wrist Dislocation Congenital abnormalities Rheumatoid arthritis Osteoarthritis Liver failure Pregnancy Bilateral CTS Systemic neurological condition e.g.: GB syndrome, multiple sclerosis.

Sites / Locations

  • Rawal Institute of Health Sciences
  • Islamabad physiotherapy rehabilitation centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Carpal bone mobilization

Flexor retinaculum stretch

Carpal bone mobilization and flexor retinaculum stretch

Arm Description

Carpal bone mobilization will be done

Flexor retinaculum stretch will be given.

Carpal bone mobilization and flexor retinaculum stretch will be given together

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)
Changes from baseline. NPRS is an 11 point numeric scale scored from 0-10. The maximum pain value is 10. 0 means no pain whereas 10 means most intense pain imaginable
Boston Carpal Tunnel Questionnaire (BCTQ) scale (SSS, FSS)
Changes from baseline. The Boston Carpal Tunnel Score is a patient-reported questionnaire that examines symptom severity and overall functional status. It has two subscales. The Symptom Severity Scale (SSS) with 11 questions is scored on a Likert scale from 1-5 where 1 means no symptom and 5 means most severe symptom. The maximum score is 55. The Functional Status Scale (FSS) with 8 questions is scored from 1-5 with 1 as no difficulty and 5 as "cannot do at all due to hand or wrist symptoms". The maximum score is 40.
6-item CTS symptoms scale (CTS-6)
Changes from baseline.The CTS-6 was scored with conventional scoring (similar to that used for the 11-item symptom severity scale) each item was scored on a scale of 1 (no symptom) to 5 (most severe symptom).
ROM wrist flexion
Changes from baseline ROM range of motion of wrist flexion was taken by using Goniometer
ROM wrist extenion
Changes from baseline ROM range of motion of wrist extension was taken by using Goniometer
ROM radial deviation
Changes from baseline ROM range of motion of radial deviation was taken by using Goniometer
ROM ulnar deviation
Changes from baseline ROM range of motion of ulnar deviation was taken by using Goniometer

Secondary Outcome Measures

Full Information

First Posted
February 20, 2023
Last Updated
May 17, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05863780
Brief Title
Comparison of Flexor Retinaculum Stretch and Carpal Mobilizations in Patients With Carpal Tunnel Syndrome.
Official Title
Comparison of Flexor Retinaculum Stretch and Carpal Mobilizations in Patients With Carpal Tunnel Syndrome on Pain, ROM and Functional Status
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
September 10, 2022 (Actual)
Study Completion Date
January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparison of flexor retinaculum stretch and carpal mobilizations in carpal tunnel syndrome patients.
Detailed Description
Carpal Bones Mobilization tends to improve the symptoms of carpal tunnel syndrome. Manual stretching of the flexor retinaculum effective in CTS patients. As there are no studies available to compare the effectiveness of flexor retinaculum stretch and carpal bone mobilization for the treatment of CTS, hence the purpose of this study is to find the effectiveness of carpal bone mobilization and flexor retinaculum stretch in improving Pain, ROM and Functional Status in patient with CTS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
median neuropathy, thenar muscle atrophy, compression neuropathy, flexor retinaculum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carpal bone mobilization
Arm Type
Experimental
Arm Description
Carpal bone mobilization will be done
Arm Title
Flexor retinaculum stretch
Arm Type
Experimental
Arm Description
Flexor retinaculum stretch will be given.
Arm Title
Carpal bone mobilization and flexor retinaculum stretch
Arm Type
Experimental
Arm Description
Carpal bone mobilization and flexor retinaculum stretch will be given together
Intervention Type
Other
Intervention Name(s)
Carpal bone mobilization
Intervention Description
Carpal bone mobilization 5 repetition/1 set lasted for 15 secs followed by 10 secs of rest- 3 sessions on alternate days per week for 04 weeks. Total of 12 sessions will be given, each consisting of 45 mins.
Intervention Type
Other
Intervention Name(s)
Flexor retinaculum stretch
Intervention Description
Flexor retinaculum stretch 5 repetitions/ 1 set held for 60 secs at a time,-3 sessions on alternate days per week for 04 weeks. Total of 12 sessions will be given, each consisting of 45 mins.
Intervention Type
Other
Intervention Name(s)
Carpal bone mobilization and flexor retinaculum stretch
Intervention Description
Carpal bone mobilization 5 repetition/1 set lasted for 15 secs followed by 10 secs of rest.3 sessions on alternate days per week for 04 weeks. Flexor retinaculum stretch 5 repetitions/ 1 set held for 60 secs at a time-3 sessions on alternate days per week for 04 weeks. Total of 12 sessions will be given, each consisting of 45 mins.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
Changes from baseline. NPRS is an 11 point numeric scale scored from 0-10. The maximum pain value is 10. 0 means no pain whereas 10 means most intense pain imaginable
Time Frame
4th week
Title
Boston Carpal Tunnel Questionnaire (BCTQ) scale (SSS, FSS)
Description
Changes from baseline. The Boston Carpal Tunnel Score is a patient-reported questionnaire that examines symptom severity and overall functional status. It has two subscales. The Symptom Severity Scale (SSS) with 11 questions is scored on a Likert scale from 1-5 where 1 means no symptom and 5 means most severe symptom. The maximum score is 55. The Functional Status Scale (FSS) with 8 questions is scored from 1-5 with 1 as no difficulty and 5 as "cannot do at all due to hand or wrist symptoms". The maximum score is 40.
Time Frame
4th week
Title
6-item CTS symptoms scale (CTS-6)
Description
Changes from baseline.The CTS-6 was scored with conventional scoring (similar to that used for the 11-item symptom severity scale) each item was scored on a scale of 1 (no symptom) to 5 (most severe symptom).
Time Frame
4th week
Title
ROM wrist flexion
Description
Changes from baseline ROM range of motion of wrist flexion was taken by using Goniometer
Time Frame
4th week
Title
ROM wrist extenion
Description
Changes from baseline ROM range of motion of wrist extension was taken by using Goniometer
Time Frame
4th week
Title
ROM radial deviation
Description
Changes from baseline ROM range of motion of radial deviation was taken by using Goniometer
Time Frame
4th week
Title
ROM ulnar deviation
Description
Changes from baseline ROM range of motion of ulnar deviation was taken by using Goniometer
Time Frame
4th week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females Age between 18-40 years Unilateral CTS Already diagnosed patients of CTS. Exclusion Criteria: Fracture of wrist Dislocation Congenital abnormalities Rheumatoid arthritis Osteoarthritis Liver failure Pregnancy Bilateral CTS Systemic neurological condition e.g.: GB syndrome, multiple sclerosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Affan Iqbal, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rawal Institute of Health Sciences
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
45550
Country
Pakistan
Facility Name
Islamabad physiotherapy rehabilitation centre
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46220
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Flexor Retinaculum Stretch and Carpal Mobilizations in Patients With Carpal Tunnel Syndrome.

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