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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05852288
Other study ID # 012/007075
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 15, 2023
Est. completion date September 15, 2023

Study information

Verified date May 2023
Source Ahram Canadian University
Contact Mohamed M ElMeligie, Ph.d
Phone +201064442032
Email mohamed.elmeligie@acu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 15, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Inflammatory markers
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-a), as well as clinical measures of CTS severity.

Locations

Country Name City State
Egypt Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al ?ayy Ath Thamin Giza

Sponsors (1)

Lead Sponsor Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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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