Predicting pain in carpal tunnel syndrome using sensory testing
Quantitative Sensory Testing to Predict Progression to Nociplastic Pain in Carpal Tunnel Syndrome: A Prospective Cohort Study
This study is testing if a special sensory test can help predict if people with carpal tunnel syndrome will develop ongoing pain over the next year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Ahram Canadian University Academic / other |
| Locations | 1 site (Al Ḩayy Ath Thāmin, Giza) |
| Trial ID | NCT05959954 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of quantitative sensory testing (QST) in predicting the development of nociplastic pain in patients diagnosed with carpal tunnel syndrome (CTS). A total of 120 adults aged 18-60 will be recruited, and baseline QST measures will be taken. Participants will be monitored over a one-year period to assess the progression to nociplastic pain, thereby determining the predictive value of the QST results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a clinical diagnosis of carpal tunnel syndrome and specific electrodiagnostic findings.
Not a fit: Patients with diabetes mellitus, cervical radiculopathy, or other neuromuscular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for developing chronic pain, allowing for earlier interventions.
How similar studies have performed: While there is limited data on the predictive use of QST in CTS, similar approaches in other pain conditions have shown promise, making this study a potentially novel exploration.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Al Ḩayy Ath Thāmin, Giza
- Outpatient clinic of faculty of physical therapy, Ahram Canadian University — Al Ḩayy Ath Thāmin, Giza, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed M ElMeligie, Ph.d
- Email: mohamed.elmeligie@acu.edu.eg
- Phone: +201064442032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.