Back to resultsThe Effectiveness of Stretching and Orthoses in Individuals With Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Prefabricated Orthoses
general and lumbrical muscle stretching
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group A: Stretching and Prefabricated Orthoses
Group B: Orthoses Alone
Group C: Placebo Treatment
Arm 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.
Participants in this arm will receive prefabricated wrist orthoses only.
Participants in this arm will receive placebo treatment consisting of gentle wrist and hand movements.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Grip Strength
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
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.
Full Information
NCT ID
NCT05838989
First Posted
April 20, 2023
Last Updated
April 20, 2023
Sponsor
Ahram Canadian University
1. Study Identification
Unique Protocol Identification Number
NCT05838989
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 16, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized into one of three groups: stretching and prefabricated orthoses, orthoses alone, or a placebo treatment.
Masking
Outcomes Assessor
Masking Description
Participants and care providers will not be blinded to the treatment group, but outcomes assessors will be blinded to the treatment group.
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: Stretching and Prefabricated Orthoses
Arm Type
Experimental
Arm 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.
Arm Title
Group B: Orthoses Alone
Arm Type
Experimental
Arm Description
Participants in this arm will receive prefabricated wrist orthoses only.
Arm Title
Group C: Placebo Treatment
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive placebo treatment consisting of gentle wrist and hand movements.
Intervention Type
Device
Intervention Name(s)
Prefabricated Orthoses
Intervention Description
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
Other
Intervention Name(s)
general and lumbrical muscle stretching
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Boston Carpal Tunnel Questionnaire (BCTQ)
Description
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.
Time Frame
Changes in BCTQ at baseline, 8 weeks, and 16 weeks.
Title
Pain Levels
Description
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.
Time Frame
Changes in pain level at baseline, 8 weeks, and 16 weeks.
Secondary Outcome Measure Information:
Title
Grip Strength
Description
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.
Time Frame
Changes in grip strength at baseline, 8 weeks, and 16 weeks.
Title
Nerve Conduction Studies
Description
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.
Time Frame
Changes in nerve conduction studies at baseline, 8 weeks, and 16 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Chair
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual participant data (IPD) collected during this study will be available upon reasonable request. Requests for access to the data should be submitted via email to mohamed.elmeligie@acu.edu.eg. All requests will be reviewed by the study investigators to ensure that they are reasonable and consistent with the ethical principles of the study. Access to the data will be granted in compliance with applicable laws and regulations, and with appropriate safeguards to protect the privacy and confidentiality of study participants.
IPD Sharing Time Frame
During the trial and 1 year after it ends
IPD Sharing Access Criteria
via email to mohamed.elmeligie@acu.edu.eg
Learn more about this trial
The Effectiveness of Stretching and Orthoses in Individuals With Carpal Tunnel Syndrome
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