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NCT Number: NCT06635200

Pain Phenotype in Patients With Carpal Tunnel Syndrome

The aim of this study was to determine the dominant pain phenotype in a group of patients with Carpal Tunnel Syndrome by applying the International Association for the Study of Pain (IASP) criteria.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kutahya Health Science University

Kütahya, Turkey (Türkiye)

About this study

Voluntary participants between the ages of 18-65 who have been diagnosed with CTS will be included in the study.The 7 steps in the Clinical Criteria/Rating System determined by the International Association for the Study of Pain (IASP) for Nosiplastic Pain and Carpal Tunnel Syndrome will be applied to people with CTS. Thermal pain threshold, mechanical pain sensitivity and static/dynamic allodynia will be evaluated to determine pain hypersensitivity (Step 5). Specific questions will be asked to confirm the history of hypersensitivity in patients (Step 6). Finally, comorbidities, if any, will be determined (Step 7). As a result, the pain phenotype of patients with CTS will be determined (Nociceptive, Neuropathic or Nosiplastic). Shapiro-Wilk test will be performed to determine the distribution of the data. One-way ANOVA (continuous) or Kruskal-Wallis (categorical) will be used to examine whether the dependent variables differ between groups. For significant F-test, an additional investigation of differences between groups will be performed with Gabriel's post hoc procedure.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being diagnosed with CTS
  • Being between the ages of 18-65
  • Volunteering to participate in the study

Exclusion criteria

  • Having systemic inflammatory disease
  • Having a disease that may cause polyneuropathy such as diabetes mellitus
  • Having a pacemaker
  • Having a disease affecting the central nervous system
  • Having cervical radiculopathy
  • History of previous operation or local steroid injection due to CTS
  • Hypersensitivity to heat and cold

Treatment and study plan

Primary outcomes

  1. Numerical Rating Scale

    Time frame: 1 minute

    Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").

Secondary outcomes

  1. Cold Pain Threshold

    Time frame: 2 minutes

    For cold pain threshold, ice cubes (-5°C) placed in a plastic bag will be placed on the patients' skin for 10 seconds. Increased sensory perception will be considered as gain of function. The intensity of pain will also be recorded on an NRS scale ranging from 0 (no pain) to 10 (worst pain imaginable).

  2. Hot Pain Threshold

    Time frame: 2 minutes

    Thermal pain perception will be tested using a 3 cm2 sized metal piece equal to (lab-QST thermode size). The metal parts will be heated to 45˚C for hot pain threshold. The metal pieces will be applied to the skin for 3 seconds. It will be determined whether the stimulus is painful (yes/no), and if painful, the intensity of the pain on a numerical rating scale (NRS) (0: no pain, 10: imaginably worse pain).

  3. Mechanical Pain Threshold

    Time frame: 3 minutes

    Mechanical pain threshold: to be assessed with a toothpick and a von Frey filament (256 mN). Increased sensory perception will be considered to reflect gain of function. The intensity of pain will also be recorded on an NRS scale ranging from 0 (no pain at all) to 10 (worst pain imaginable).

  4. Static mechanical allodynia

    Time frame: 3 minutes

    A digital algometer will be used to measure Pressure Pain Threshold levels. Pressure will be applied at a rate of approximately 30 kPa with the algometer placed perpendicular to the point of application. Participants will be instructed to report when the sensation changes from pressure to pain. The intensity of pain will also be recorded on an NRS scale ranging from 0 (no pain at all) to 10 (worst pain imaginable).

  5. Dynamic Mechanical Allodynia

    Time frame: 3 minutes

    Patients will be touched on the affected area and the control area with a brush, an ear stick and a piece of cotton wool. The assessment tools will be applied 4 times by drawing a cross of 2 strokes (length 5 cm) at an angle of 90˚C in each direction. For each stimulus (brush/ear swab/cotton swab), they will indicate (1) whether the stimulus was perceived as painful (yes/no) and (2) the pain intensity on the NRS-11 (0 no pain, 10 imaginably worse pain).

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Determination of Dominant Pain Phenotype in Patients With Carpal Tunnel Syndrome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2024
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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