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Clinical Trials/NCT05959954
NCT05959954
Recruiting
N/A

Quantitative Sensory Testing to Predict Progression to Nociplastic Pain in Carpal Tunnel Syndrome: A Prospective Cohort Study

Ahram Canadian University1 site in 1 country120 target enrollmentJuly 21, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Carpal Tunnel Syndrome
Sponsor
Ahram Canadian University
Enrollment
120
Locations
1
Primary Endpoint
Progression to Nociplastic Pain
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 21, 2023
End Date
November 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Ahram Canadian University

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:
  • Prolonged median motor distal latency \>4.2 ms
  • 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.

Outcomes

Primary Outcomes

Progression to Nociplastic Pain

Time Frame: 1 year from the start of the study

Development of nociplastic pain in patients with carpal tunnel syndrome, as identified by a Kosek, by clinical criteria suggest by E., Clauw, D., Nijs, J., Baron, R., Gilron, I., Harris, R. E., ... \& Sterling, M. (2021). Chronic nociplastic pain affecting the musculoskeletal system: clinical criteria and grading system. Pain, 162(11), 2629-2634.

Secondary Outcomes

  • Change in Quantitative Sensory Testing (QST) Measures(Changes in QST at baseline and 1 year)

Study Sites (1)

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