Carpal Tunnel SyndromeNCT05863780

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

A study testing Carpal bone mobilization, Flexor retinaculum stretch and Carpal bone mobilization and flexor retinaculum stretch in people with Carpal Tunnel Syndrome, run by Riphah International University at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Comparison of flexor retinaculum stretch and carpal mobilizations in carpal tunnel syndrome patients. Read more about this study

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: Carpal Tunnel Syndrome
What is being tested?: Carpal bone mobilization, Flexor retinaculum stretch and Carpal bone mobilization and flexor retinaculum stretch
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 2 sitesPakistan
Study dates: 10 Mar 2022to 10 Jan 2023
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 18 to 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

Females
Age between 18-40 years
Unilateral CTS
Already diagnosed patients of CTS.

Who cannot join

Fracture of wrist
Dislocation
Congenital abnormalities
Rheumatoid arthritis
Osteoarthritis
Liver failure

Show all 9Show fewer

Pregnancy
Bilateral CTS
Systemic neurological condition e.g.: GB syndrome, multiple sclerosis.

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites

Rawal Institute of Health Sciences
Rawalpindi, Punjab Province, 45550
Islamabad physiotherapy rehabilitation centre
Rawalpindi, Punjab Province, 46220

Other trials in Pakistan

About this study

Official title: Comparison of Flexor Retinaculum Stretch and Carpal Mobilizations in Patients With Carpal Tunnel Syndrome on Pain, ROM and Functional Status

Comparison of flexor retinaculum stretch and carpal mobilizations in carpal tunnel syndrome patients.

Read the 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.

Conditions: Carpal Tunnel Syndrome
Being tested: Carpal bone mobilization, Flexor retinaculum stretch, Carpal bone mobilization and flexor retinaculum stretch
Keywords: median neuropathy, thenar muscle atrophy, compression neuropathy, flexor retinaculum
Medical subject headings: Carpal Tunnel Syndrome, Median Neuropathy, Tomaculous neuropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Carpal bone mobilizationOther
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.
Flexor retinaculum stretchOther
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.
Carpal bone mobilization and flexor retinaculum stretchOther
1. 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.
2. 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.

Study groups in NCT05863780
Study group	Role	What they receive
Carpal bone mobilization	Experimental	Carpal bone mobilization will be done Receives: Other: Carpal bone mobilization
Flexor retinaculum stretch	Experimental	Flexor retinaculum stretch will be given. Receives: Other: Flexor retinaculum stretch
Carpal bone mobilization and flexor retinaculum stretch	Experimental	Carpal bone mobilization and flexor retinaculum stretch will be given together Receives: Other: Carpal bone mobilization and flexor retinaculum stretch

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 4th week
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.
1. 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.
2. 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.
Measured: 4th week
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).
Measured: 4th week
ROM wrist flexion
Changes from baseline ROM range of motion of wrist flexion was taken by using Goniometer
Measured: 4th week
ROM wrist extenion
Changes from baseline ROM range of motion of wrist extension was taken by using Goniometer
Measured: 4th week
ROM radial deviation
Changes from baseline ROM range of motion of radial deviation was taken by using Goniometer
Measured: 4th week
ROM ulnar deviation
Changes from baseline ROM range of motion of ulnar deviation was taken by using Goniometer
Measured: 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 202210 Jan 2023

First posted18 May 2023
Study start10 Mar 2022
Primary completion10 Sep 2022
Study completion10 Jan 2023

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 Riphah International UniversityThe 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: Participant
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05863780
Sponsor's protocol ID: Riphah/RCRS/REC/01317
Status last verified: May 2023
First submitted: 20 Feb 2023
Last updated: 18 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery

All Carpal Tunnel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Flexor Retinaculum Stretch and Carpal Mobilizations in Patients With Carpal Tunnel Syndrome on Pain, ROM and Functional Status
ClinicalTrials.gov ID: NCT05863780
Acronym / sponsor ID: Riphah/RCRS/REC/01317
Conditions: Carpal Tunnel Syndrome
Keywords: median neuropathy, thenar muscle atrophy, compression neuropathy, flexor retinaculum
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Riphah International UniversityUniversity, hospital or other
Study start: 10 Mar 2022 (actual)
Primary completion: 10 Sep 2022 (actual)
Study completion: 10 Jan 2023 (actual)
First posted: 18 May 2023 (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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Carpal bone mobilization	Experimental	Other: Carpal bone mobilizationCarpal bone mobilization will be done
Flexor retinaculum stretch	Experimental	Other: Flexor retinaculum stretchFlexor retinaculum stretch will be given.
Carpal bone mobilization and flexor retinaculum stretch	Experimental	Other: Carpal bone mobilization and flexor retinaculum stretchCarpal bone mobilization and flexor retinaculum stretch will be given together

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Females
Age between 18-40 years
Unilateral CTS
Already diagnosed patients of CTS.

Key exclusion criteria (9 listed)

Fracture of wrist
Dislocation
Congenital abnormalities
Rheumatoid arthritis
Osteoarthritis

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
Carpal bone mobilizationCarpal 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.	Other	Carpal bone mobilization
Flexor retinaculum stretchFlexor 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.	Other	Flexor retinaculum stretch
Carpal bone mobilization and flexor retinaculum stretch1. 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. 2. 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.	Other	Carpal bone mobilization and flexor retinaculum stretch

Primary outcome

Numeric Pain Rating Scale (NPRS)
Time frame: 4th week
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)
Time frame: 4th week
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. 1. 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. 2. 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)
Time frame: 4th week
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
Time frame: 4th week
Changes from baseline ROM range of motion of wrist flexion was taken by using Goniometer
ROM wrist extenion
Time frame: 4th week
Changes from baseline ROM range of motion of wrist extension was taken by using Goniometer
ROM radial deviation
Time frame: 4th week
Changes from baseline ROM range of motion of radial deviation was taken by using Goniometer
ROM ulnar deviation
Time frame: 4th week
Changes from baseline ROM range of motion of ulnar deviation was taken by using Goniometer

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 18 May 2023.
Individual participant dataSharing planned: No

Related trials for Carpal Tunnel Syndrome

Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery

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.

Muhammad Affan Iqbal, PhD* principal investigator

Riphah International University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 9 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 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Numeric Pain Rating Scale (NPRS) (time frame: 4th week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05863780.

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 18 May 2023.