Predicting Nociplastic Pain in Carpal Tunnel Syndrome Through Quantitative Sensory Testing

Quantitative Sensory Testing to Predict Progression to Nociplastic Pain in Carpal Tunnel Syndrome: A Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Diagnostic test: Quantitative Sensory Testing (QST)

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Mohamed M ElMeligie, Ph.d; Phone Number: +201064442032; Email: mohamed.elmeligie@acu.edu.eg

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with clinical and electrodiagnostic evidence of carpal tunnel syndrome.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Carpal Tunnel Syndrome (CTS) Patients; Adults with clinical and electrodiagnostic evidence of carpal tunnel syndrome.

Diagnostic test: Quantitative 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Changes in QST at baseline and 1 year

Other Outcome Measures

Outcome Measure	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.	Change in hand function measures at baseline and 1 year.

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Chair: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Estimated): July 21, 2023
• Primary Completion (Estimated): July 21, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: CTS-QST-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No