Carpal Tunnel SyndromeNCT05838989
The Effectiveness of Stretching and Orthoses in Individuals With Carpal Tunnel Syndrome
A study testing Prefabricated Orthoses and general and lumbrical muscle stretching in people with Carpal Tunnel Syndrome, run by Ahram Canadian University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Prefabricated Orthoses and general and lumbrical muscle stretching
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 3 May 2023to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
About this study
Official title: Randomized Controlled Trial Comparing the Effectiveness of Stretching and Orthoses Versus Orthoses Alone in Individuals With Carpal Tunnel Syndrome
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
- Being tested
- Prefabricated Orthoses, general and lumbrical muscle stretching, Placebo
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefabricated OrthosesDevice
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 stretchingOther
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Prefabricated Orthoses; Other: general and lumbrical muscle stretching |
| Group B: Orthoses Alone | Experimental | Participants in this arm will receive prefabricated wrist orthoses only. Receives: Device: Prefabricated Orthoses |
| Group C: Placebo Treatment | Placebo comparator | Participants in this arm will receive placebo treatment consisting of gentle wrist and hand movements. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Changes in pain level at baseline, 8 weeks, and 16 weeks.
Secondary outcomes (2)
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.
Measured: Changes in grip strength at baseline, 8 weeks, and 16 weeks.
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.
Measured: Changes in nerve conduction studies at baseline, 8 weeks, and 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start3 May 2023
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into one of three groups: stretching and prefabricated orthoses, orthoses alone, or a placebo treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study chair, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838989
- Sponsor's protocol ID
- 012/0701
- Status last verified
- Jul 2024
- First submitted
- 20 Apr 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Effectiveness of Stretching and Orthoses Versus Orthoses Alone in Individuals With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05838989
- Acronym / sponsor ID
- 012/0701
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized into one of three groups: stretching and prefabricated orthoses, orthoses alone, or a placebo treatment.
| Arm | Type | Receives |
|---|---|---|
| Group A: Stretching and Prefabricated Orthoses | Experimental | Device: Prefabricated Orthoses, Other: general and lumbrical muscle stretchingParticipants 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 B: Orthoses Alone | Experimental | Device: Prefabricated OrthosesParticipants in this arm will receive prefabricated wrist orthoses only. |
| Group C: Placebo Treatment | Placebo comparator | Other: PlaceboParticipants in this arm will receive placebo treatment consisting of gentle wrist and hand movements. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prefabricated OrthosesParticipants 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. | Device | Group A: Stretching and Prefabricated Orthoses, Group B: Orthoses Alone |
| general and lumbrical muscle stretchingParticipants 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. | Other | Group A: Stretching and Prefabricated Orthoses |
| PlaceboParticipants 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. | Other | Group C: Placebo Treatment |
Primary outcome
Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: 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
Time frame: 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.
2 secondary outcomes
Grip Strength
Time frame: Changes in grip strength at baseline, 8 weeks, and 16 weeks.
Nerve Conduction Studies
Time frame: Changes in nerve conduction studies at baseline, 8 weeks, and 16 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Fawzy, Ph.d study chair
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prefabricated Orthoses and general and lumbrical muscle stretching in people with Carpal Tunnel Syndrome, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Carpal Tunnel Questionnaire (BCTQ) (time frame: Changes in BCTQ at baseline, 8 weeks, and 16 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.