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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflammatory markers | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 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. | 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 | 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. | Changes of inflammatory markers and nerve conduction study at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed M ElMeligie, Ph.d | Contact | +201064442032 | mohamed.elmeligie@acu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Amal Fawzy, Ph.d | Faculty of Physical Therapy, Ahram Canadian University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient clinic of faculty of physical therapy, Ahram Canadian University | Al Ḩayy Ath Thāmin | Giza Governorate | 3221405 | Egypt |
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.
After finishing the trial and up to 1 year.
via email to mohamed.elmeligie@acu.edu.eg
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |