The Effectiveness of Stretching and Orthoses in Individuals With Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Device: Prefabricated Orthoses; Other: Placebo; Other: general and lumbrical muscle stretching

• Registration Number: NCT05838989
• Lead Sponsor: Ahram Canadian University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-04-20
• Study Start: 2023-05-03
• Study First Posted: 2023-05-03
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Stretching and Prefabricated Orthoses	Prefabricated Orthoses	Participants in this arm will receive supervised general and lumbrical muscle stretching exercises for 10 minutes, three times per week, for 8 weeks, as well as prefabricated wrist orthoses.
Group A: Stretching and Prefabricated Orthoses	general and lumbrical muscle stretching	Participants in this arm will receive supervised general and lumbrical muscle stretching exercises for 10 minutes, three times per week, for 8 weeks, as well as prefabricated wrist orthoses.
Group C: Placebo Treatment	Placebo	Participants in this arm will receive placebo treatment consisting of gentle wrist and hand movements.
Group B: Orthoses Alone	Prefabricated Orthoses	Participants in this arm will receive prefabricated wrist orthoses only.

Primary Outcome Measures

Name	Time	Method
Boston Carpal Tunnel Questionnaire (BCTQ)	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	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 Outcome Measures

Name	Time	Method
Grip Strength	Changes in grip strength at baseline, 8 weeks, and 16 weeks.	Grip strength will be measured using a hand-held dynamometer. Participants will be instructed to grip the dynamometer as hard as possible, and the maximum force generated will be recorded in kilograms. Grip strength is a commonly used outcome measure in hand rehabilitation research and is a reliable and valid measure of hand function.
Nerve Conduction Studies	Changes in nerve conduction studies at baseline, 8 weeks, and 16 weeks.	Nerve conduction studies will be used to assess the severity and extent of median nerve involvement in participants with carpal tunnel syndrome. The studies will be performed by a trained neurophysiologist using standard techniques and equipment.

Trial Locations

Locations (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt