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

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conservative Approach
Surgical Approach
Sponsored by
Combined Military Hospital Abbottabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Combined Military Hospital Abbottabad

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Patients

Principle Investigator

Consultant Orthopedic Surgeon

Arm Description

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.

The principal investigator will carry out the whole study.

Consultant Orthopedic Surgeon will be outcome assessor.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 24, 2023
Last Updated
September 24, 2023
Sponsor
Combined Military Hospital Abbottabad
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1. Study Identification

Unique Protocol Identification Number
NCT06060314
Brief Title
Comparison of Efficacy Between Conservative Versus Operative Management of Carpel Tunnel Syndrome
Official Title
Comparison of Efficacy Between Conservative Versus Operative Management of Carpel Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
June 3, 2022 (Actual)
Study Completion Date
September 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Abbottabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Other
Arm Description
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.
Arm Title
Principle Investigator
Arm Type
Other
Arm Description
The principal investigator will carry out the whole study.
Arm Title
Consultant Orthopedic Surgeon
Arm Type
Other
Arm Description
Consultant Orthopedic Surgeon will be outcome assessor.
Intervention Type
Procedure
Intervention Name(s)
Conservative Approach
Other Intervention Name(s)
Splinting
Intervention Description
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
Intervention Name(s)
Surgical Approach
Other Intervention Name(s)
open carpal tunnel release (OCTR)
Intervention Description
Patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR)
Primary Outcome Measure Information:
Title
Efficacy in terms of Functional Status Scale Score (FSS Score)
Description
Efficacy was determined in terms of functional improvement from the baseline as per Functional Status Scale Score
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Ad Afsar
Organizational Affiliation
Combined Military Hospital Abbottabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Combined Military Hospital Abbottabad
City
Abbottabad
State/Province
Khyber Pukhtunkhwa
ZIP/Postal Code
22020
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
I am not going to share it with other researchers.

Learn more about this trial

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

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