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

Ahram Canadian University

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Other: Placebo; Device: Prefabricated Orthoses; Other: general and lumbrical muscle stretching

Study type: Interventional

Funder types: Other

Identifiers

NCT05838989

012/0701

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

75 participants in 3 patient groups, including a placebo group

Group A: Stretching and Prefabricated Orthoses

Experimental group

Description:

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.

Treatment:

Other: general and lumbrical muscle stretching

Device: Prefabricated Orthoses

Group B: Orthoses Alone

Experimental group

Description:

Participants in this arm will receive prefabricated wrist orthoses only.

Treatment:

Device: Prefabricated Orthoses

Group C: Placebo Treatment

Placebo Comparator group

Description:

Participants in this arm will receive placebo treatment consisting of gentle wrist and hand movements.

Treatment:

Other: Placebo