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Predicting Nociplastic Pain in Carpal Tunnel Syndrome Through Quantitative Sensory Testing

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ClinicalTrials.gov Identifier: NCT05959954
Recruitment Status : Recruiting
First Posted : July 25, 2023
Last Update Posted : July 25, 2023
Sponsor:
Information provided by (Responsible Party):
Mohamed Magdy ElMeligie, Ahram Canadian University

Study Description
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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.

Condition or disease Intervention/treatment
Carpal Tunnel Syndrome 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 Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative Sensory Testing to Predict Progression to Nociplastic Pain in Carpal Tunnel Syndrome: A Prospective Cohort Study
Estimated Study Start Date : July 21, 2023
Estimated Primary Completion Date : July 21, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Progression to Nociplastic Pain [ Time Frame: 1 year from the start of the study ]
    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.


Secondary Outcome Measures :
  1. Change in Quantitative Sensory Testing (QST) Measures [ Time Frame: Changes in QST at baseline and 1 year ]
    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.


Other Outcome Measures:
  1. Change in Hand Function [ Time Frame: Change in hand function measures at baseline and 1 year. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with clinical and electrodiagnostic evidence of carpal tunnel syndrome.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05959954


Contacts
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Contact: Mohamed M ElMeligie, Ph.d +201064442032 mohamed.elmeligie@acu.edu.eg

Locations
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Egypt
Outpatient clinic of faculty of physical therapy, Ahram Canadian University Recruiting
Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
Contact: Mohamed M ElMeligie, Ph.d    01064442032    mohamed.elmeligie@acu.edu.eg   
Sponsors and Collaborators
Ahram Canadian University
Investigators
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Study Chair: Amal Fawzy, Ph.d Faculty of Physical Therapy, Ahram Canadian University
More Information
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Responsible Party: Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University
ClinicalTrials.gov Identifier: NCT05959954    
Other Study ID Numbers: CTS-QST-2023
First Posted: July 25, 2023    Key Record Dates
Last Update Posted: July 25, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries