Predicting Nociplastic Pain in Carpal Tunnel Syndrome Through Quantitative Sensory Testing

NCT ID: NCT05959954

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-21
• Study Completion Date: 2024-11-30

Brief Summary

This study aims to investigate the predictive value of quantitative sensory testing (QST) in identifying patients with carpal tunnel syndrome (CTS) who are at risk of developing nociplastic pain.

Detailed Description

The study will recruit 120 adults diagnosed with CTS and conduct baseline QST measures. The progression to nociplastic pain will be assessed over a one-year follow-up period to determine the predictive value of QST measures.

Conditions

Carpal Tunnel Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Carpal Tunnel Syndrome (CTS) Patients

Adults with clinical and electrodiagnostic evidence of carpal tunnel syndrome.

Quantitative Sensory Testing (QST)

Intervention Type: DIAGNOSTIC_TEST

Quantitative Sensory Testing (QST) is a non-invasive diagnostic method used to assess sensory dysfunction. The test evaluates individual thresholds and pain responses to different types of mechanical, thermal, and electrical stimuli. For this study, QST will be used to gather baseline sensory data for patients with carpal tunnel syndrome. This information will then be used to predict the progression to nociplastic pain over a one-year follow-up period.

Interventions

Quantitative Sensory Testing (QST)

Quantitative Sensory Testing (QST) is a non-invasive diagnostic method used to assess sensory dysfunction. The test evaluates individual thresholds and pain responses to different types of mechanical, thermal, and electrical stimuli. For this study, QST will be used to gather baseline sensory data for patients with carpal tunnel syndrome. This information will then be used to predict the progression to nociplastic pain over a one-year follow-up period.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Adults ages 18-60
• Clinical diagnosis of CTS based on presence of parasthesias and/or pain in median nerve distribution, positive Phalen's test and/or Tinel's sign, and nocturnal symptoms
• Electrodiagnostic evidence of median neuropathy at the wrist:

1. Prolonged median motor distal latency >4.2 ms

2. Prolonged median sensory latency >3.4 ms

• Symptom duration between 6 months and 2 years (to exclude very early or very late stages)
• Pain severity of ≥5 on 0-10 numerical rating scale
• No evidence of thenar muscle atrophy on physical exam
• No prior surgery or fracture of the affected wrist
• No evidence of comorbid diabetes mellitus, cervical radiculopathy, polyneuropathy, or other neuromuscular disorders

Exclusion Criteria

• Diabetes mellitus, as a common cause of polyneuropathy, which can confound QST measures.
• Cervical radiculopathy or other upper limb neuropathies, which can cause overlapping sensory symptoms and signs.
• History of wrist fracture or surgery, which may cause structural abnormalities affecting nerve function.
• Pregnancy, due to physiological changes that can affect nerve function.
• Patients with severe thenar muscle atrophy, indicating long-standing severe median neuropathy.
• Patients unable to provide informed consent or comply with study procedures.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahram Canadian University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Fawzy, Ph.d

Role: STUDY_CHAIR

Faculty of Physical Therapy, Ahram Canadian University

Locations

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed M ElMeligie, Ph.d

Role: CONTACT

mohamed.elmeligie@acu.edu.eg

+201064442032

Facility Contacts

Mohamed M ElMeligie, Ph.d

Role: primary

mohamed.elmeligie@acu.edu.eg

01064442032

Other Identifiers

CTS-QST-2023

Identifier Type: -

Identifier Source: org_study_id