Comparison of Efficacy Between Conservative Versus Operative Management of Carpel Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

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.
    

Intervention name(s): Conservative Approach; Surgical Approach
Intervention type(s): Procedure; Procedure
Intervention description(s): 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; Patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR)
Other intervention name(s): Splinting; open carpal tunnel release (OCTR)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment