Predicting Nociplastic Pain in Carpal Tunnel Syndrome Through Quantitative Sensory Testing

NCT05959954 | Unknown DMC

• 1 other identifier: CTS-QST-2023
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

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.

  1 year from the start of the study

Secondary Outcomes (1)

• Change in Quantitative Sensory Testing (QST) Measures

  Changes in QST at baseline and 1 year

Other Outcomes (1)

• Change in Hand Function

  Change in hand function measures at baseline and 1 year.

Study Arms (1)

Carpal Tunnel Syndrome (CTS) Patients

Adults with clinical and electrodiagnostic evidence of carpal tunnel syndrome.

Diagnostic Test: Quantitative Sensory Testing (QST)

Interventions

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.

Carpal Tunnel Syndrome (CTS) Patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults with clinical and electrodiagnostic evidence of carpal tunnel syndrome.

You may qualify if:

• 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:
• Prolonged median motor distal latency \>4.2 ms
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY CHAIR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 25, 2023
• Study Start: July 21, 2023
• Primary Completion: July 21, 2024
• Study Completion: November 30, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)