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RecruitingNCT05959954Updated Jul 25, 2023

Predicting Nociplastic Pain in Carpal Tunnel Syndrome Through Quantitative Sensory Testing

An observational study in Carpal Tunnel Syndrome, sponsored by Ahram Canadian University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-07-25.

Sponsored by Ahram Canadian University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Carpal Tunnel Syndrome
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In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.

This study's planned enrollment of 120 is above the median of 90 across 127 observational studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Ahram Canadian University is the lead sponsor of 69 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults with clinical and electrodiagnostic evidence of carpal tunnel syndrome.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Carpal Tunnel Syndrome (CTS) Patients

    Adults with clinical and electrodiagnostic evidence of carpal tunnel syndrome.

    Diagnostic Test: Quantitative Sensory Testing (QST)

Interventions

  • Diagnostic testQuantitative Sensory Testing (QST)

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year from the start of the study

Secondary outcomes

  1. 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.

    Time frame: Changes in QST at baseline and 1 year

Other outcomes

  1. 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.

    Time frame: Change in hand function measures at baseline and 1 year.

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Study locations

1 of 1 sites recruiting
  • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
    Al Ḩayy Ath Thāmin, Giza 3221405, Egypt
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05959954
Lead sponsor
Ahram Canadian University
Responsible party
Mohamed Magdy ElMeligie (Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University) — Principal investigator
First posted
Jul 25, 2023
Start date
Jul 21, 2023 (estimated)
Primary completion
Jul 21, 2024 (estimated)
Completion
Nov 30, 2024 (estimated)
Last update
Jul 25, 2023

Study contacts

Mohamed M ElMeligie, Ph.d
Contact
mohamed.elmeligie@acu.edu.eg
+201064442032
Amal Fawzy, Ph.d
study chair · Faculty of Physical Therapy, Ahram Canadian University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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