Comparison of Efficacy Between Conservative Versus Operative Management of Carpel Tunnel Syndrome
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
Procedure: 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
Other Names:
Procedure: Surgical Approach
Patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR)
Other Names:
|
| Other: Principle Investigator The principal investigator will carry out the whole study. |
Procedure: 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
Other Names:
Procedure: Surgical Approach
Patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR)
Other Names:
|
| Other: Consultant Orthopedic Surgeon Consultant Orthopedic Surgeon will be outcome assessor. |
Procedure: 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
Other Names:
Procedure: Surgical Approach
Patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Combined Military Hospital Abbottabad | Abbottabad | Khyber Pukhtunkhwa | Pakistan | 22020 |
Sponsors and Collaborators
- Combined Military Hospital Abbottabad
Investigators
- Principal Investigator: Muhammad Ad Afsar, Combined Military Hospital Abbottabad
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Combined Military Hospital Ab