NCT06519058

Brief Summary

Background/Objectives: Carpal tunnel syndrome (CTS), a median mononeuropathy from nerve compression in the wrist's carpal tunnel, will be studied to compare self-myofascial carpal ligament stretching plus conventional physical therapy versus physical therapy alone for pain reduction and function improvement in stage I/II CTS patients. Methods: Thirty-six eligible stage I/II CTS patients will be randomized (18/group). The experimental group will receive self-myofascial stretching + conventional therapy; controls will get conventional therapy only. Treatment will last 6 weeks; outcomes will be assessed via Boston Carpal Tunnel Questionnaire and Visual Analogue Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

December 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

June 27, 2024

Last Update Submit

December 9, 2025

Conditions

Patients With Stage I and II Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (2)

  • Boston Carpal Tunnel Questionnaire

    Used to assess the function of carpals

    6 weeks

  • Visual Analogue Scale

    Involves asking participants to rate their current level of pain on a scale from 0= No pain to 10= maximum pain is felt.

    6 weeks

Study Arms (2)

self-myofascial stretching group

EXPERIMENTAL
Other: self-myofascial stretching

conventional physical therapy group

SHAM COMPARATOR
Other: conventional physical therapy

Interventions

self-myofascial stretchingOTHER

self-myofascial stretching exercise

self-myofascial stretching group
conventional physical therapyOTHER

conventional physical therapy treatment, including exercises

conventional physical therapy group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed CTS, stage I/II (EMG-confirmed).
  • Age 30-60 years.
  • Both genders.
  • Dominant hand (unilateral/bilateral).
  • English literate.

You may not qualify if:

  • Polyneuropathy.
  • Adaptive equipment use.
  • Shoulder pathologies.
  • Other neurological/musculoskeletal conditions.
  • Recent carpal tunnel release (\<1 year).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Awh special college

Calicut, India

Location

Study Officials

  • Shibili Nuhmani, PhD

    Imam Abdulrahman Bin Faisal 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
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 25, 2024

Study Start

December 1, 2023

Primary Completion

February 4, 2024

Study Completion

May 29, 2024

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations

IN(1)