Clinical trial NCT05852288: Role of Inflammation in Carpal Tunnel Syndrome
Official title: Role of Inflammation in Carpal Tunnel Syndrome: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carpal Tunnel Syndrome
Median Neuropathy, Carpal Tunnel
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The relationship between inflammatory markers and symptom severity of carpal tunnel syndrome (CTS).
timeFrame: Changes of inflammatory markers and symptoms severity at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline
measure: The relationship between inflammatory markers and grip strength of patients with CTS.
timeFrame: Changes of inflammatory markers and grip strength at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline
measure: The relationship between inflammatory markers and pinch strength of CTS patients.
timeFrame: Changes of inflammatory markers and pinch strength at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline
measure: The relationship between inflammatory markers and nerve conduction study of patients with CTS
timeFrame: Changes of inflammatory markers and nerve conduction study at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References: