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

NCT ID: NCT06060314

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-03

Study Completion Date

2022-09-03

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was a randomized control trial. 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).
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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. 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 by consultant orthopedic surgeon. Data was recorded by the principle investigator under the supervision of consultant orthopedic surgeon.

Study Groups

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Patients

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.

Group Type OTHER

Conservative Approach

Intervention Type PROCEDURE

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

Surgical Approach

Intervention Type PROCEDURE

Patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR)

Principle Investigator

The principal investigator will carry out the whole study.

Group Type OTHER

Conservative Approach

Intervention Type PROCEDURE

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

Surgical Approach

Intervention Type PROCEDURE

Patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR)

Consultant Orthopedic Surgeon

Consultant Orthopedic Surgeon will be outcome assessor.

Group Type OTHER

Conservative Approach

Intervention Type PROCEDURE

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

Surgical Approach

Intervention Type PROCEDURE

Patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR)

Interventions

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Conservative Approach

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

Intervention Type PROCEDURE

Surgical Approach

Patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR)

Intervention Type PROCEDURE

Other Intervention Names

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Splinting open carpal tunnel release (OCTR)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Combined Military Hospital Abbottabad

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Adnan Afsar

Major Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Ad Afsar

Role: PRINCIPAL_INVESTIGATOR

Combined Military Hospital Abbottabad

Locations

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Combined Military Hospital Abbottabad

Abbottabad, Khyber Pukhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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Combined Military Hospital Ab

Identifier Type: -

Identifier Source: org_study_id