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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: Carpal bone mobilization; Other: Flexor retinaculum stretch; Other: Carpal bone mobilization and flexor retinaculum stretch

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carpal bone mobilization; Carpal bone mobilization will be done	Other: Carpal bone mobilization; 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.
Experimental: Flexor retinaculum stretch; Flexor retinaculum stretch will be given.	Other: Flexor retinaculum stretch; 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.
Experimental: Carpal bone mobilization and flexor retinaculum stretch; Carpal bone mobilization and flexor retinaculum stretch will be given together	Other: Carpal bone mobilization and flexor retinaculum stretch; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.; 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.	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).	4th week
ROM wrist flexion	Changes from baseline ROM range of motion of wrist flexion was taken by using Goniometer	4th week
ROM wrist extenion	Changes from baseline ROM range of motion of wrist extension was taken by using Goniometer	4th week
ROM radial deviation	Changes from baseline ROM range of motion of radial deviation was taken by using Goniometer	4th week
ROM ulnar deviation	Changes from baseline ROM range of motion of ulnar deviation was taken by using Goniometer	4th week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Muhammad Affan Iqbal, PhD*, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): September 10, 2022
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: compression neuropathy; median neuropathy; thenar muscle atrophy; flexor retinaculum
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: Riphah/RCRS/REC/01317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No