An interventional study of Conservative Approach and Surgical Approach in Carpal Tunnel Syndrome, sponsored by Combined Military Hospital Abbottabad. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Combined Military Hospital Abbottabad · Not applicable, Interventional, and Treatment
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.
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.
587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 443 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Combined Military Hospital Abbottabad is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
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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.
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 · Procedure: Surgical Approach
The principal investigator will carry out the whole study.
Procedure: Conservative Approach · Procedure: Surgical Approach
Consultant Orthopedic Surgeon will be outcome assessor.
Procedure: Conservative Approach · Procedure: Surgical 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
Also known as: Splinting
Patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR)
Also known as: open carpal tunnel release (OCTR)
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
Time frame: 3 months
Plan to share: No — I am not going to share it with other researchers.
No publications or documents are linked to this record.
Ran from Mar 2022 to primary completion in Jun 2022, 3 months.
Of 251 non-industry interventional studies with no phase under Carpal Tunnel Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 27. This study's 3 months is below that.
Counting every sponsor, half of 261 studies reached it within 12 months; a quarter within 7 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Combined Military Hospital Abbottabad