Comparison of Efficacy Between Conservative Versus Operative Management of Carpel Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Conservative Approach; Procedure: Surgical Approach

• Registration Number: NCT06060314
• Lead Sponsor: Combined Military Hospital Abbottabad

Brief Summary

Patients presented with symptoms of numbness at night, pain, or tingling sensation in the fingers particularly at night diagnosed by consultant orthopedic surgeon on physical examination. Patients in Group A were treated conservatively i.e splinting in neutral position of wrist for 6 wks min at night and during the day as preferred while patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR). Patients were assessed during a follow up visit at 3rd month measured using functional status scale of the Boston questionnaire (BQ). Efficacy was determined in terms of functional improvement from the baseline.

Detailed Description

This randomized controlled trial was conducted at the Department of Orthopedic Surgery, CMH Abbottabad, from 3 March 2022 to 3 September 2022. Ethical approval (file no: CMH-ADT-73-Ortho-23) was sought from the Ethical Committee.

The sample size was calculated by WHO Sample Size calculator with 90% 10 efficacy of surgical treatment and 59.1% 11 efficacy of conservative treatment, with 80% power of test and 5% significance level. Nonprobability consecutive sampling technique was used to gather the sample for this trial.

Inclusion Criteria: Patients of either gender, aged between 18 to 60 years presented with symptoms of numbness at night, pain, or tingling sensation in the fingers particularly at night diagnosed for Carpal tunnel syndrome (CTS) by consultant orthopedic surgeon on physical examination were included in the study.

Exclusion Criteria: Patients already under treatment for carpal tunnel syndrome (CTS) were excluded.

Written informed consent was also taken from all the study participants after a complete description. Carpal tunnel syndrome (CTS) was diagnosed by consultant orthopedic surgeon on physical examination having symptoms of numbness at night, pain, or tingling sensation in the fingers particularly at night. To ensure randomization, the lottery method was used to allocate the patients to study groups. Patients in Group A were treated conservatively i.e Splinting in neutral position of wrist for 6 wks min at night and during the day as preferred while patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR). Patients were assessed during a follow up visit at 3rd month measured using functional status scale of the Boston questionnaire (BQ). The Functional Status Scale (FSS) from the Boston Carpal Tunnel Questionnaire is an 8-item questionnaire originally developed by Levine et al. \[10\] to assess functional abilities in patients with CTS. Each item of the FSS is rated on a scale from "1" "no difficulty" to "5" "unable." The overall score for the FSS was calculated as the mean of the completed items, and ranges from 1 to 5. Higher scores indicated greater disability. Efficacy was determined in terms of functional improvement from the baseline. An improvement of '2' points from the baseline was termed efficacious.

Study Timeline

• Study Start: 2022-03-03
• Primary Completion: 2022-06-03
• Study Completion: 2022-09-03
• Status Verified: 2023-09
• Study First Submitted: 2023-09-24
• Study First Submitted QC: 2023-09-24
• Last Update Submitted: 2023-09-24
• Study First Posted: 2023-09-29
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients of either gender, aged between 18 to 60 years presented with symptoms of numbness at night, pain, or tingling sensation in the fingers particularly at night diagnosed for Carpal tunnel syndrome (CTS) by a consultant orthopedic surgeon on physical examination were included in the study.

Exclusion Criteria

Patients already under treatment for carpal tunnel syndrome (CTS) were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients	Conservative Approach	Patients presented with symptoms of numbness at night, pain, or tingling sensation in the fingers particularly at night diagnosed by a consultant orthopedic surgeon on physical examination.
Principle Investigator	Surgical Approach	The principal investigator will carry out the whole study.
Consultant Orthopedic Surgeon	Surgical Approach	Consultant Orthopedic Surgeon will be outcome assessor.
Principle Investigator	Conservative Approach	The principal investigator will carry out the whole study.
Patients	Surgical Approach	Patients presented with symptoms of numbness at night, pain, or tingling sensation in the fingers particularly at night diagnosed by a consultant orthopedic surgeon on physical examination.
Consultant Orthopedic Surgeon	Conservative Approach	Consultant Orthopedic Surgeon will be outcome assessor.

Primary Outcome Measures

Name	Time	Method
Efficacy in terms of Functional Status Scale Score (FSS Score)	3 months	Efficacy was determined in terms of functional improvement from the baseline as per Functional Status Scale Score

Trial Locations

Locations (1)

Combined Military Hospital Abbottabad; 🇵🇰 Abbottabad, Khyber Pukhtunkhwa, Pakistan