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Completed

NCT Number: NCT06060314

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Combined Military Hospital Abbottabad

Abbottabad, Khyber Pukhtunkhwa, 22020, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conservative approach

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

Other names: Splinting

Surgical approach

Procedure

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

Other names: open carpal tunnel release (OCTR)

Primary outcomes

  1. Efficacy in terms of Functional Status Scale Score (FSS Score)

    Time frame: 3 months

    Efficacy was determined in terms of functional improvement from the baseline as per Functional Status Scale Score

Sponsors and collaborators

Lead sponsor

Combined Military Hospital Abbottabad

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2023
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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