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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carpal Tunnel Syndrome (CTS) Patients | Adults with clinical and electrodiagnostic evidence of carpal tunnel syndrome. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative Sensory Testing (QST) | 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. |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hand Function | Hand function can be measured using tools like the Boston Carpal Tunnel Questionnaire, which includes two scales: the Symptom Severity Scale and the Functional Status Scale. The Symptom Severity Scale measures the severity and frequency of symptoms, while the Functional Status Scale measures the impact of these symptoms on daily activities. Each item on these scales is rated on a scale of 1 (no symptoms or difficulty) to 5 (most severe symptoms or difficulty). Higher scores on the Symptom Severity Scale and lower scores on the Functional Status Scale indicate worse hand function. An increase in the Symptom Severity Scale score or a decrease in the Functional Status Scale score over time would indicate a worsening of hand function. |
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:
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:
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Adults with clinical and electrodiagnostic evidence of carpal tunnel syndrome.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed M ElMeligie, Ph.d | Contact | +201064442032 | mohamed.elmeligie@acu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Amal Fawzy, Ph.d | Faculty of Physical Therapy, Ahram Canadian University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient clinic of faculty of physical therapy, Ahram Canadian University | Recruiting | Al Ḩayy Ath Thāmin | Giza Governorate | 3221405 | Egypt |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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|
| Changes in QST at baseline and 1 year |
| Change in hand function measures at baseline and 1 year. |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |