Role of Inflammation in Carpal Tunnel Syndrome

NCT05852288 | Unknown

• 1 other identifier: 012/007075
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Median Neuropathy, Carpal Tunnel

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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.

Diagnostic Test: Inflammatory markers

Interventions

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.

Individuals with carpal tunnel syndrome

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY CHAIR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 10, 2023
• Study Start: May 15, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 15, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: After finishing the trial and up to 1 year.
• Access Criteria: via email to mohamed.elmeligie@acu.edu.eg

Locations

EG (1)