Clinical trial NCT05838989: The Effectiveness of Stretching and Orthoses in Individuals With Carpal Tunnel Syndrome
Official title: Randomized Controlled Trial Comparing the Effectiveness of Stretching and Orthoses Versus Orthoses Alone in Individuals With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of three groups: stretching and prefabricated orthoses, orthoses alone, or a placebo treatment.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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).
3. 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.
4. Participants must be willing and able to provide informed consent to participate in the study.

Exclusion Criteria:

1. 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.
2. 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.
3. 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.
4. Participants with any other medical condition that could affect hand function or interfere with test completion, such as rheumatoid arthritis, osteoarthritis, or peripheral neuropathy.
5. 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.
6. Participants who are unable to comply with study procedures or follow-up requirements, such as attending scheduled study visits or completing study questionnaires.

Primary outcomes:
measure: Boston Carpal Tunnel Questionnaire (BCTQ)
timeFrame: Changes in BCTQ at baseline, 8 weeks, and 16 weeks.
measure: Pain Levels
timeFrame: Changes in pain level at baseline, 8 weeks, and 16 weeks.
Secondary outcomes:
measure: Grip Strength
timeFrame: Changes in grip strength at baseline, 8 weeks, and 16 weeks.
measure: Nerve Conduction Studies
timeFrame: Changes in nerve conduction studies at baseline, 8 weeks, and 16 weeks.
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References: