Carpal Tunnel SyndromeNCT05852288
Role of Inflammation in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome and Median Neuropathy, Carpal Tunnel, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
This study aims to investigate the role of inflammation in carpal tunnel syndrome (CTS) using a prospective cohort study design. The study will involve a sample of at least 50 individuals with CTS who will undergo a comprehensive clinical and biochemical evaluation to assess the role of inflammation in CTS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Median Neuropathy, Carpal Tunnel
- What is being tested?
- Inflammatory markers
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2023to 15 Sep 2023
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population will be recruited from a single center and will include at least 50 individuals with CTS. The population may include individuals of all ages, but the study will likely focus on middle-aged and older adults, as CTS is more common in this population. The study population will be diverse in terms of gender and race/ethnicity to ensure that the study findings are generalizable to a broader population.
Who may be able to join
- Individuals aged 18 years or older
- Diagnosis of carpal tunnel syndrome based on clinical symptoms and nerve conduction studies
- Willingness and ability to provide informed consent to participate in the study
- Willingness and ability to comply with study procedures and follow-up visits
Who cannot join
- Presence of other neurological conditions that may affect nerve function in the upper extremities
- Use of medications that may affect inflammation or carpal tunnel syndrome severity
- History of previous carpal tunnel release surgery on the affected wrist
- Inability to comply with study procedures or follow-up visits
- Pregnancy or breastfeeding
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: Role of Inflammation in Carpal Tunnel Syndrome: A Prospective Cohort Study
This study aims to investigate the role of inflammation in carpal tunnel syndrome (CTS) using a prospective cohort study design. The study will involve a sample of at least 50 individuals with CTS who will undergo a comprehensive clinical and biochemical evaluation to assess the role of inflammation in CTS. The primary outcome measures include inflammatory markers, such as C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), as well as clinical measures of CTS severity. Data will be analyzed using regression analysis to determine the relationship between inflammation and CTS. The study is expected to provide information on the role of inflammation in CTS and inform the choice of drug and concentration for transdermal drug administration.
- Being tested
- Inflammatory markers
- 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.
Inflammatory markersDiagnostic test
Participants in this cohort will undergo a comprehensive clinical and biochemical evaluation to assess the role of inflammation in CTS. The evaluation will include assessments of inflammatory markers, such as C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), as well as clinical measures of CTS severity.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with carpal tunnel syndrome | This study will follow a group of individuals with carpal tunnel syndrome (CTS) according to Bland's grading scale (grades 1-3) to assess the role of inflammation in CTS. Participants will undergo clinical and biochemical evaluations to assess inflammatory markers and CTS severity. The study will follow participants over time to determine the relationship between inflammation and CTS, which can inform the choice of transdermal drug administration. Receives: Diagnostic Test: Inflammatory markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between inflammatory markers and symptom severity of carpal tunnel syndrome (CTS).
interleukin-6, tumor necrosis factor-alpha using blood tests. Symptom severity will be assessed with standardized questionnaire "the Boston Carpal Tunnel Questionnaire".
Measured: Changes of inflammatory markers and symptoms severity at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline
The relationship between inflammatory markers and grip strength of patients with CTS.
interleukin-6, tumor necrosis factor-alpha using blood tests. functional status by grip strength using a dynamometer.
Measured: Changes of inflammatory markers and grip strength at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline
The relationship between inflammatory markers and pinch strength of CTS patients.
interleukin-6, tumor necrosis factor-alpha using blood tests. pinch strength will be measured using a dynamometer
Measured: Changes of inflammatory markers and pinch strength at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline
The relationship between inflammatory markers and nerve conduction study of patients with CTS
interleukin-6, tumor necrosis factor-alpha using blood tests. Nerve conduction study results (motor and sensory distal latency of median nerve and amplitude) will be used to determine CTS severity based on Bland's grading scale.
Measured: Changes of inflammatory markers and nerve conduction study at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start15 May 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
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
- NCT05852288
- Sponsor's protocol ID
- 012/007075
- Status last verified
- May 2023
- First submitted
- 19 Apr 2023
- Last updated
- 10 May 2023
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Inflammation in Carpal Tunnel Syndrome: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05852288
- Acronym / sponsor ID
- 012/007075
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 10 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.
This study aims to investigate the role of inflammation in carpal tunnel syndrome (CTS) using a prospective cohort study design. The study will involve a sample of at least 50 individuals with CTS who will undergo a comprehensive clinical and biochemical evaluation to assess the role of inflammation in CTS. The primary outcome measures include inflammatory markers, such as C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), as well as clinical measures of CTS severity. Data will be analyzed using regression analysis to determine the relationship between inflammation and CTS. The study is expected to provide information on the role of inflammation in CTS and inform the choice of drug and concentration for transdermal drug administration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with carpal tunnel syndrome | – | Diagnostic Test: Inflammatory markersThis study will follow a group of individuals with carpal tunnel syndrome (CTS) according to Bland's grading scale (grades 1-3) to assess the role of inflammation in CTS. Participants will undergo clinical and biochemical evaluations to assess inflammatory markers and CTS severity. The study will follow participants over time to determine the relationship between inflammation and CTS, which can inform the choice of transdermal drug administration. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will be recruited from a single center and will include at least 50 individuals with CTS. The population may include individuals of all ages, but the study will likely focus on middle-aged and older adults, as CTS is more common in this population. The study population will be diverse in terms of gender and race/ethnicity to ensure that the study findings are generalizable to a broader population.
Key inclusion criteria (4 listed)
- Individuals aged 18 years or older
- Diagnosis of carpal tunnel syndrome based on clinical symptoms and nerve conduction studies
- Willingness and ability to provide informed consent to participate in the study
- Willingness and ability to comply with study procedures and follow-up visits
Key exclusion criteria (5 listed)
- Presence of other neurological conditions that may affect nerve function in the upper extremities
- Use of medications that may affect inflammation or carpal tunnel syndrome severity
- History of previous carpal tunnel release surgery on the affected wrist
- Inability to comply with study procedures or follow-up visits
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Inflammatory markersParticipants in this cohort will undergo a comprehensive clinical and biochemical evaluation to assess the role of inflammation in CTS. The evaluation will include assessments of inflammatory markers, such as C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), as well as clinical measures of CTS severity. | Diagnostic test | Individuals with carpal tunnel syndrome |
Primary outcome
The relationship between inflammatory markers and symptom severity of carpal tunnel syndrome (CTS).
Time frame: Changes of inflammatory markers and symptoms severity at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline
interleukin-6, tumor necrosis factor-alpha using blood tests. Symptom severity will be assessed with standardized questionnaire "the Boston Carpal Tunnel Questionnaire".
The relationship between inflammatory markers and grip strength of patients with CTS.
Time frame: Changes of inflammatory markers and grip strength at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline
interleukin-6, tumor necrosis factor-alpha using blood tests. functional status by grip strength using a dynamometer.
The relationship between inflammatory markers and pinch strength of CTS patients.
Time frame: Changes of inflammatory markers and pinch strength at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline
interleukin-6, tumor necrosis factor-alpha using blood tests. pinch strength will be measured using a dynamometer
The relationship between inflammatory markers and nerve conduction study of patients with CTS
Time frame: Changes of inflammatory markers and nerve conduction study at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline
interleukin-6, tumor necrosis factor-alpha using blood tests. Nerve conduction study results (motor and sensory distal latency of median nerve and amplitude) will be used to determine CTS severity based on Bland's grading scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- 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?
An observational study of Carpal Tunnel Syndrome and Median Neuropathy, Carpal Tunnel, 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 5 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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between inflammatory markers and symptom severity of carpal tunnel syndrome (CTS). (time frame: Changes of inflammatory markers and symptoms severity at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline). The study lists 4 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 10 May 2023.