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

NCT ID: NCT05838989

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2024-06-24

Brief Summary

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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

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized into one of three groups: stretching and prefabricated orthoses, orthoses alone, or a placebo treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Participants and care providers will not be blinded to the treatment group, but outcomes assessors will be blinded to the treatment group.

Study Groups

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Group A: Stretching and 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 Type EXPERIMENTAL

Prefabricated Orthoses

Intervention Type DEVICE

Participants in this group will be provided with prefabricated wrist orthoses to wear during the day and at night to provide support and immobilization to the wrist. Participants will be instructed to wear the orthoses as directed by their healthcare provider.

general and lumbrical muscle stretching

Intervention Type OTHER

Participants in this group will receive supervised general and lumbrical muscle stretching exercises for 10 minutes, three times per week, for 8 weeks. The stretching exercises will be performed under the supervision of a trained therapist and will include a series of exercises designed to stretch the muscles in the hands, wrists, and forearms. In addition, participants will be provided with prefabricated wrist orthoses to wear during the day and at night to provide support and immobilization to the wrist.

Group B: Orthoses Alone

Participants in this arm will receive prefabricated wrist orthoses only.

Group Type EXPERIMENTAL

Prefabricated Orthoses

Intervention Type DEVICE

Participants in this group will be provided with prefabricated wrist orthoses to wear during the day and at night to provide support and immobilization to the wrist. Participants will be instructed to wear the orthoses as directed by their healthcare provider.

Group C: Placebo Treatment

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants in this group will receive placebo treatment consisting of gentle wrist and hand movements. The movements will be performed under the supervision of a trained therapist and will consist of gentle range of motion exercises designed to mobilize the joints in the hands and wrists. Participants will not be provided with any orthoses to wear during the study.

Interventions

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Prefabricated Orthoses

Participants in this group will be provided with prefabricated wrist orthoses to wear during the day and at night to provide support and immobilization to the wrist. Participants will be instructed to wear the orthoses as directed by their healthcare provider.

Intervention Type DEVICE

general and lumbrical muscle stretching

Participants in this group will receive supervised general and lumbrical muscle stretching exercises for 10 minutes, three times per week, for 8 weeks. The stretching exercises will be performed under the supervision of a trained therapist and will include a series of exercises designed to stretch the muscles in the hands, wrists, and forearms. In addition, participants will be provided with prefabricated wrist orthoses to wear during the day and at night to provide support and immobilization to the wrist.

Intervention Type OTHER

Placebo

Participants in this group will receive placebo treatment consisting of gentle wrist and hand movements. The movements will be performed under the supervision of a trained therapist and will consist of gentle range of motion exercises designed to mobilize the joints in the hands and wrists. Participants will not be provided with any orthoses to wear during the study.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahram Canadian University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amal Fawzy, Ph.d

Role: STUDY_CHAIR

Faculty of Physical Therapy, Ahram Canadian University

Locations

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Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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012/0701

Identifier Type: -

Identifier Source: org_study_id

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