Carpal Tunnel SyndromeNCT05460026
Effects Of Power Ball Exercises In Addition To Routine Physical Therapy In Patients With Carpal Tunnel Syndrome
A study testing Routine Physical Therapy and Powerball Exercises in people with Carpal Tunnel Syndrome, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Routine Physical Therapy and Powerball Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Dec 2021to 23 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Routine Physical Therapy, Powerball Exercises
- Keywords
- Physical therapy, Median Neuropathy, Power Ball Exercise, Carpal Tunnel Syndrome
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Physical TherapyOther
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).
Powerball ExercisesOther
Participants will be using the Powerball™ for 5 minutes per hand, 3 times a week along with routine physical therapy exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Routine physical therapy will be given to the participants of group A Receives: Other: Routine Physical Therapy |
| Group B | Experimental | Powerball exercises with routine physical therapy will be given to the participants of group B Receives: Other: Powerball Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain Intensity will be measured by Numeric Rating Scale (NRS)
Measured: Change in pain will be measured at initial visit, at sixth session and at the twelfth session.
Grip Strength
Grip Strength will be measured by using handheld dynamometry (HHD)
Measured: Change in grip strength will be measured at initial visit, at sixth session and at the twelfth session.
Functional Disability
Functional disability will be measured by Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
Measured: Change in functional disability will be measured at initial visit, at sixth session and at the twelfth session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start23 Dec 2021
- Primary completion23 May 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Jamil, University of Lahore
- Investigators
- Ashfaq Ahmed, PhD, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460026
- Sponsor's protocol ID
- Muhammad Jahanzaib Rasool
- Status last verified
- Apr 2023
- First submitted
- 1 Jul 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Immediately after publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05460026
- Acronym / sponsor ID
- Muhammad Jahanzaib Rasool
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Physical therapy, Median Neuropathy, Power Ball Exercise, Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Routine Physical TherapyRoutine physical therapy will be given to the participants of group A |
| Group B | Experimental | Other: Powerball ExercisesPowerball exercises with routine physical therapy will be given to the participants of group B |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Physical TherapyParticipants 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). | Other | Group A |
| Powerball ExercisesParticipants will be using the Powerball™ for 5 minutes per hand, 3 times a week along with routine physical therapy exercises. | Other | Group B |
Primary outcome
Pain Intensity
Time frame: Change in pain will be measured at initial visit, at sixth session and at the twelfth session.
Pain Intensity will be measured by Numeric Rating Scale (NRS)
Grip Strength
Time frame: Change in grip strength will be measured at initial visit, at sixth session and at the twelfth session.
Grip Strength will be measured by using handheld dynamometry (HHD)
Functional Disability
Time frame: Change in functional disability will be measured at initial visit, at sixth session and at the twelfth session.
Functional disability will be measured by Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: Yes. Immediately after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashfaq Ahmed, PhD study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Physical Therapy and Powerball Exercises in people with Carpal Tunnel Syndrome, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Change in pain will be measured at initial visit, at sixth session and at the twelfth session.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.