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

NCT06060314 | Completed DMC

• 1 other identifier: Combined Military Hospital Ab
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Study Arms (3)

Patients

OTHER

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

Principle Investigator

OTHER

The principal investigator will carry out the whole study.

Procedure: Conservative Approach; Procedure: Surgical Approach

Consultant Orthopedic Surgeon

OTHER

Consultant Orthopedic Surgeon will be outcome assessor.

Procedure: Conservative Approach; Procedure: Surgical Approach

Interventions

Conservative Approach PROCEDURE

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

Consultant Orthopedic Surgeon; Patients; Principle Investigator

Surgical Approach PROCEDURE

Patients in Group B were managed through surgical intervention i.e open carpal tunnel release (OCTR)

Also known as: open carpal tunnel release (OCTR)

Consultant Orthopedic Surgeon; Patients; Principle Investigator

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients already under treatment for carpal tunnel syndrome (CTS) were excluded.

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

Combined Military Hospital Abbottabad

Abbottabad, Khyber Pukhtunkhwa, 22020, Pakistan

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Splints

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Muhammad Ad Afsar

  Combined Military Hospital Abbottabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Major Doctor

Model Details: 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).

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: September 29, 2023
• Study Start: March 3, 2022
• Primary Completion: June 3, 2022
• Study Completion: September 3, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)