NCT05863780

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

February 20, 2023

Last Update Submit

May 17, 2023

Conditions

Keywords

median neuropathythenar muscle atrophycompression neuropathyflexor retinaculum

Outcome Measures

Primary Outcomes (7)

  • 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. 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.

    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

Study Arms (3)

Carpal bone mobilization

EXPERIMENTAL

Carpal bone mobilization will be done

Other: Carpal bone mobilization

Flexor retinaculum stretch

EXPERIMENTAL

Flexor retinaculum stretch will be given.

Other: Flexor retinaculum stretch

Carpal bone mobilization and flexor retinaculum stretch

EXPERIMENTAL

Carpal bone mobilization and flexor retinaculum stretch will be given together

Other: Carpal bone mobilization and flexor retinaculum stretch

Interventions

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.

Carpal bone mobilization

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.

Flexor retinaculum stretch

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.

Carpal bone mobilization and flexor retinaculum stretch

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Fracture of wrist
  • Dislocation
  • Congenital abnormalities
  • Rheumatoid arthritis
  • Osteoarthritis
  • Liver failure
  • Pregnancy
  • Bilateral CTS
  • Systemic neurological condition e.g.: GB syndrome, multiple sclerosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rawal Institute of Health Sciences

Rawalpindi, Punjab Province, 45550, Pakistan

Location

Islamabad physiotherapy rehabilitation centre

Rawalpindi, Punjab Province, 46220, Pakistan

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromeMedian NeuropathyTomaculous neuropathy

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Muhammad Affan Iqbal, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

May 18, 2023

Study Start

March 10, 2022

Primary Completion

September 10, 2022

Study Completion

January 10, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations