Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06060314
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2023-09-24
Brief Title:
Comparison of Efficacy Between Conservative Versus Operative Management of Carpel Tunnel Syndrome
Sponsor:
Combined Military Hospital Abbottabad
Organization:
Combined Military Hospital Abbottabad
Study Overview
Official Title:
Comparison of Efficacy Between Conservative Versus Operative Management of Carpel Tunnel Syndrome
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 ie 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 591 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 ie 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 ie 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
The sample size was calculated by WHO Sample Size calculator with 90 10 efficacy of surgical treatment and 591 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 ie 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None