Back to resultsEffects Of Power Ball Exercises In Addition To Routine Physical Therapy In Patients With Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Routine Physical Therapy
Powerball Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Physical therapy, Median Neuropathy, Power Ball Exercise, Carpal Tunnel Syndrome
Eligibility Criteria
Inclusion Criteria:
- Age group 45-60 years
- Both male and female
- Clinically diagnosed carpal tunnel syndrome
- Carpal Tunnel Syndrome for a duration of more than 02 months
- Tingling sensation and numbness over the dorsal surface of thumb, index, middle, and lateral 1/3rd of ring fingers
- Positive Tinel's sign
- Positive Phalen's Maneuver
Exclusion Criteria:
- Any previous trauma, fracture, subluxation, dislocation, surgery or bony abnormalities around wrist joint in the past 5 years.
- Symptomatic Arthritis of wrist joint
- Cervical radiculopathy
- Corticosteroid injection within 3 months
Sites / Locations
- The University of Lahore
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A
Group B
Arm Description
Routine physical therapy will be given to the participants of group A
Powerball exercises with routine physical therapy will be given to the participants of group B
Outcomes
Primary Outcome Measures
Pain Intensity
Pain Intensity will be measured by Numeric Rating Scale (NRS)
Grip Strength
Grip Strength will be measured by using handheld dynamometry (HHD)
Functional Disability
Functional disability will be measured by Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05460026
Brief Title
Effects Of Power Ball Exercises In Addition To Routine Physical Therapy In Patients With Carpal Tunnel Syndrome
Official Title
Effects Of Power Ball Exercises In Addition To Routine Physical Therapy On Pain, Grip Strength And Functional Disability In Patients With Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 23, 2021 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose for doing this study is to determine that whether use of Power Ball in form of resistance training will be effective in increasing grip strength in carpel tunnel syndrome patient and possible benefits of the regime as effective means of rehabilitation for wrist and hand injuries. Moreover for increasing grip strength it can be used as an adjunct for physical therapy treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Physical therapy, Median Neuropathy, Power Ball Exercise, Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The study will be single blinded in which the assessor will be unaware of the treatment intervention.
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Routine physical therapy will be given to the participants of group A
Arm Title
Group B
Arm Type
Experimental
Arm Description
Powerball exercises with routine physical therapy will be given to the participants of group B
Intervention Type
Other
Intervention Name(s)
Routine Physical Therapy
Intervention Description
Participants will receive routine physical therapy which includes ultrasound, nerve gliding, tendon mobilization, stretching, mobility and strengthening exercises for the wrist. Each session will last for 30 minutes with 12 sessions on alternate days (3 sessions / week).
Intervention Type
Other
Intervention Name(s)
Powerball Exercises
Intervention Description
Participants will be using the Powerball™ for 5 minutes per hand, 3 times a week along with routine physical therapy exercises.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Pain Intensity will be measured by Numeric Rating Scale (NRS)
Time Frame
Change in pain will be measured at initial visit, at sixth session and at the twelfth session.
Title
Grip Strength
Description
Grip Strength will be measured by using handheld dynamometry (HHD)
Time Frame
Change in grip strength will be measured at initial visit, at sixth session and at the twelfth session.
Title
Functional Disability
Description
Functional disability will be measured by Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
Time Frame
Change in functional disability will be measured at initial visit, at sixth session and at the twelfth session.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age group 45-60 years
Both male and female
Clinically diagnosed carpal tunnel syndrome
Carpal Tunnel Syndrome for a duration of more than 02 months
Tingling sensation and numbness over the dorsal surface of thumb, index, middle, and lateral 1/3rd of ring fingers
Positive Tinel's sign
Positive Phalen's Maneuver
Exclusion Criteria:
Any previous trauma, fracture, subluxation, dislocation, surgery or bony abnormalities around wrist joint in the past 5 years.
Symptomatic Arthritis of wrist joint
Cervical radiculopathy
Corticosteroid injection within 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashfaq Ahmed, PhD
Organizational Affiliation
The University of Lahore
Official's Role
Study Director
Facility Information:
Facility Name
The University of Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Immediately after publication
IPD Sharing Time Frame
Beginning 9 months and ending on 36th month
Learn more about this trial
Effects Of Power Ball Exercises In Addition To Routine Physical Therapy In Patients With Carpal Tunnel Syndrome
We'll reach out to this number within 24 hrs