Role of Inflammation in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Role of Inflammation in Carpal Tunnel Syndrome: A Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05852288
• Other study ID #: 012/007075
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Inflammation
• Median Neuropathy
• Median Neuropathy, Carpal Tunnel
• Syndrome

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