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Comparison of Efficacy Between Conservative Versus Operative Management of Carpel Tunnel Syndrome

Comparison of Efficacy Between Conservative Versus Operative Management of Carpel Tunnel Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06060314
Enrollment
60
Registered
2023-09-29
Start date
2022-03-03
Completion date
2022-09-03
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

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.

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.

Interventions

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)

Sponsors

Combined Military Hospital Abbottabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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. 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 by consultant orthopedic surgeon. Data was recorded by the principle investigator under the supervision of consultant orthopedic surgeon.

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy in terms of Functional Status Scale Score (FSS Score)3 monthsEfficacy was determined in terms of functional improvement from the baseline as per Functional Status Scale Score

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026