Combined Military Hospital Abbottabad
Abbottabad, Khyber Pukhtunkhwa, 22020, Pakistan
NCT Number: NCT06060314
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.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Abbottabad, Khyber Pukhtunkhwa, 22020, Pakistan
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.
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.
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
Patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR)
Other names: open carpal tunnel release (OCTR)
Time frame: 3 months
Efficacy was determined in terms of functional improvement from the baseline as per Functional Status Scale Score
Combined Military Hospital Abbottabad
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT07334964
Carpal Tunnel Syndrome, Cumulative Trauma Disorders
Orléans, France
View Trial DetailsNCT04737239
Carpal Tunnel Syndrome, Cumulative Trauma Disorders
Detroit, Michigan, United States
View Trial DetailsNCT07724717
Carpal Tunnel Syndrome, Cumulative Trauma Disorders
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT07105540
Carpal Tunnel Syndrome, Cumulative Trauma Disorders
Ankara, Yenimahalle, Turkey (Türkiye)
View Trial Details