Role of Inflammation in Carpal Tunnel Syndrome

Sponsor
Ahram Canadian University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05852288
Collaborator
(none)
50
1
4
12.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Inflammatory markers

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Role of Inflammation in Carpal Tunnel Syndrome: A Prospective Cohort Study
Anticipated Study Start Date :
May 15, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 15, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. The relationship between inflammatory markers and symptom severity of carpal tunnel syndrome (CTS). [Changes of inflammatory markers and symptoms severity at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline]

    interleukin-6, tumor necrosis factor-alpha using blood tests. Symptom severity will be assessed with standardized questionnaire "the Boston Carpal Tunnel Questionnaire".

  2. The relationship between inflammatory markers and grip strength of patients with CTS. [Changes of inflammatory markers and grip strength at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline]

    interleukin-6, tumor necrosis factor-alpha using blood tests. functional status by grip strength using a dynamometer.

  3. The relationship between inflammatory markers and pinch strength of CTS patients. [Changes of inflammatory markers and pinch strength at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline]

    interleukin-6, tumor necrosis factor-alpha using blood tests. pinch strength will be measured using a dynamometer

  4. The relationship between inflammatory markers and nerve conduction study of patients with CTS [Changes of inflammatory markers and nerve conduction study at baseline, 4 weeks, 8 weeks, and 12 weeks after baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al Ḩayy Ath Thāmin Giza Egypt 3221405

Sponsors and Collaborators

  • Ahram Canadian University

Investigators

  • Study Chair: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University
ClinicalTrials.gov Identifier:
NCT05852288
Other Study ID Numbers:
  • 012/007075
First Posted:
May 10, 2023
Last Update Posted:
May 10, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2023