Predicting Nociplastic Pain in Carpal Tunnel Syndrome Through Quantitative Sensory Testing

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Diagnostic Test: Quantitative Sensory Testing (QST)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carpal Tunnel Syndrome (CTS) Patients<br>Adults with clinical and electrodiagnostic evidence of carpal tunnel syndrome. | Diagnostic Test: Quantitative Sensory Testing (QST)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression to Nociplastic Pain | 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. | 1 year from the start of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quantitative Sensory Testing (QST) Measures | A significant change in QST measures could indicate the progression of sensory abnormalities in the participants. QST measures include thermal detection and pain thresholds, mechanical detection and pain thresholds, and vibration detection thresholds. Each of these thresholds is measured using specific testing equipment and protocols, and the exact scoring can vary based on the specific equipment and protocol used. In general, lower thresholds (i.e., the patient detects the stimulus at lower intensities) may indicate heightened sensitivity or hyperalgesia, while higher thresholds may indicate reduced sensitivity or hypoesthesia. Changes in these thresholds over time can indicate a worsening of sensory dysfunction. | Changes in QST at baseline and 1 year |