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

NCT05838989 | Completed

• 1 other identifier: 012/0701
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (2)

• Boston Carpal Tunnel Questionnaire (BCTQ)

  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.

  Changes in BCTQ at baseline, 8 weeks, and 16 weeks.

• Pain Levels

  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.

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

Secondary Outcomes (2)

• 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 Arms (3)

Group A: Stretching and Prefabricated Orthoses

EXPERIMENTAL

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.

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

Group B: Orthoses Alone

EXPERIMENTAL

Participants in this arm will receive prefabricated wrist orthoses only.

Device: Prefabricated Orthoses

Group C: Placebo Treatment

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Prefabricated Orthoses 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 A: Stretching and Prefabricated Orthoses; Group B: Orthoses Alone

general and lumbrical muscle stretching 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 A: Stretching and Prefabricated Orthoses

Placebo 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.

Group C: Placebo Treatment

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and care providers will not be blinded to the treatment group, but outcomes assessors will be blinded to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

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

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: May 3, 2023
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: During the trial and 1 year after it ends
• Access Criteria: via email to mohamed.elmeligie@acu.edu.eg

Locations

EG (1)