NCT07018011

Brief Summary

This study aimed at to fill the gaps by comparing the surgical outcomes of the conventional versus transverse mini-incision technique for carpal tunnel syndrome in terms of pain and functional outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

12 months

First QC Date

June 4, 2025

Last Update Submit

June 4, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain severity

    A score percentage of 0-40 on the visual analog scale was graded as good, 50-60 as fair, and 70-100 as poor

    9 months

  • Functional outcome

    On functional severity scale, a score percentage of 20-45% was graded as good, 46-60% was graded as fair, and 61-100% was graded as poor.

    9 months

Study Arms (2)

Conventional open CTR

EXPERIMENTAL

Conventional open CTR involved making a longitudinal incision in the wrist, typically along the median palmar crease, to access and release the transverse carpal ligament.

Procedure: Conventional open CTR

Transverse mini-incision technique

EXPERIMENTAL

Mini-incision CTR involved a smaller incision than traditional CTR procedures, aiming to minimize scarring and improve recovery time.

Procedure: Transverse mini-incision technique

Interventions

Conventional open CTR involved making a longitudinal incision in the wrist, typically along the median palmar crease, to access and release the transverse carpal ligament.

Conventional open CTR

Mini-incision CTR involved a smaller incision than traditional CTR procedures, aiming to minimize scarring and improve recovery time.

Transverse mini-incision technique

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any genders
  • Aged between 18 and 70 years
  • Presenting with symptoms of carpal tunnel syndrome for at least 3 months duration, and having a VAS score \> 4.

You may not qualify if:

  • Patients with wrists with thenar atrophy
  • Those who had previous CTR surgery
  • Local injection for CTS
  • Pregnant females
  • Patients suffering from inflammatory arthropathy
  • Polyneuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahiwal Teaching Hospital

Sahiwal, Punjab Province, 57000, Pakistan

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kashif Raza, FCPS

    Sahiwal Teaching Hospital, Sahiwal

    PRINCIPAL INVESTIGATOR
  • Muhammad Rashid, FCPS

    Sahiwal Teaching Hospital, Sahiwal

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 12, 2025

Study Start

April 1, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations