Predicting Nociplastic Pain in Carpal Tunnel Syndrome Through Quantitative Sensory Testing

Recruiting

• Conditions: Carpal Tunnel Syndrome
• Interventions: Diagnostic Test: Quantitative Sensory Testing (QST)

• Registration Number: NCT05959954
• Lead Sponsor: Ahram Canadian University

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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Study Start: 2023-07-21
• Study First Posted: 2023-07-25
• Last Update Posted: 2023-07-25
• Primary Completion: 2024-07-21
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carpal Tunnel Syndrome (CTS) Patients	Quantitative Sensory Testing (QST)	Adults with clinical and electrodiagnostic evidence of carpal tunnel syndrome.

Primary Outcome Measures

Name	Time	Method
Progression to Nociplastic Pain	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 Outcome Measures

Name	Time	Method
Change in Quantitative Sensory Testing (QST) Measures	Changes in QST at baseline and 1 year	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.

Trial Locations

Locations (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt