Clinical trial NCT05959954: Predicting Nociplastic Pain in Carpal Tunnel Syndrome Through Quantitative Sensory Testing
Official title: Quantitative Sensory Testing to Predict Progression to Nociplastic Pain in Carpal Tunnel Syndrome: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with clinical and electrodiagnostic evidence of carpal tunnel syndrome.

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.

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:

  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.

Primary outcomes:
measure: Progression to Nociplastic Pain
timeFrame: 1 year from the start of the study
Secondary outcomes:
measure: Change in Quantitative Sensory Testing (QST) Measures
timeFrame: Changes in QST at baseline and 1 year
Other outcomes:
measure: Change in Hand Function
timeFrame: Change in hand function measures at baseline and 1 year.
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References: