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Clinical Trials/NCT05838989
NCT05838989
Completed
Not Applicable

Randomized Controlled Trial Comparing the Effectiveness of Stretching and Orthoses Versus Orthoses Alone in Individuals With Carpal Tunnel Syndrome

Ahram Canadian University1 site in 1 country75 target enrollmentMay 3, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carpal Tunnel Syndrome
Sponsor
Ahram Canadian University
Enrollment
75
Locations
1
Primary Endpoint
Boston Carpal Tunnel Questionnaire (BCTQ)
Status
Completed
Last Updated
last year

Overview

Brief Summary

The objective of this study is to compare the effectiveness of stretching and prefabricated orthoses versus orthoses alone in individuals with carpal tunnel syndrome (CTS) using validated condition-appropriate outcome measures such as BCTQ, pain levels, grip strength, and nerve conduction studies.

Registry
clinicaltrials.gov
Start Date
May 3, 2023
End Date
June 24, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Ahram Canadian University

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 30-60 years or older with a confirmed diagnosis of carpal tunnel syndrome based on clinical presentation and/or nerve conduction studies.
  • Participants must have a moderate level of symptom severity, defined as a score of 2 or greater on the symptom severity subscale of the Boston Carpal Tunnel Questionnaire (BCTQ).
  • Participants must have a moderate level of functional impairment, defined as a score of 2 or greater on the functional status subscale of the BCTQ.
  • Participants must be willing and able to provide informed consent to participate in the study.

Exclusion Criteria

  • Participants with a history of hand or wrist surgery within the past 6 months, as this could impact hand function and confound the study results.
  • Participants with severe hand or wrist pain that would prevent completion of the outcome measures or interfere with their ability to participate in the study.
  • Participants with severe cognitive impairment or language barrier that would prevent understanding of the study instructions or interfere with their ability to participate in the study.
  • Participants with any other medical condition that could affect hand function or interfere with test completion, such as rheumatoid arthritis, osteoarthritis, or peripheral neuropathy.
  • Participants who have participated in any other clinical trial or research study involving the hand or wrist within the past 3 months, as this could impact hand function and confound the study results.
  • Participants who are unable to comply with study procedures or follow-up requirements, such as attending scheduled study visits or completing study questionnaires.

Outcomes

Primary Outcomes

Boston Carpal Tunnel Questionnaire (BCTQ)

Time Frame: Changes in BCTQ at baseline, 8 weeks, and 16 weeks.

The BCTQ is a validated condition-specific questionnaire used to assess the severity of symptoms and functional limitations associated with carpal tunnel syndrome. The questionnaire consists of 11 items related to symptom severity and 8 items related to functional status. The scores for each set of items are combined to generate symptom severity and functional status scores, which will be used as the primary outcome measures for this study.

Pain Levels

Time Frame: Changes in pain level at baseline, 8 weeks, and 16 weeks.

Pain levels will be assessed using a visual analogue scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Participants will be asked to rate their pain levels at rest and during specific activities such as gripping, pinching, and typing.

Secondary Outcomes

  • Grip Strength(Changes in grip strength at baseline, 8 weeks, and 16 weeks.)
  • Nerve Conduction Studies(Changes in nerve conduction studies at baseline, 8 weeks, and 16 weeks.)

Study Sites (1)

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