Reliability and Validity of the IASP Clinical Criteria for Identifying Patients with Nociplastic Pain

University of Thessaly94 enrolled

Overview

This protocol will report on the validation of IASP clinical criteria for indentifying nociplastic pain. The study will include 2 phases. In the first phase, the vignette method will be used while the second phase will include the use of the algorithm in the evaluation of patients with chronic pain.

For the purposes of the study, in the first phase, clinical vignettes will be created, ie short hypothetical scenarios of patients with chronic musculoskeletal pain. The vignettes will feature patients with and without nocipalstic pain. Initially, two experts will evaluate and characterize which vignettes concern patients with nociplastic pain. Next, a team of physiotherapists with knowledge of chronic pain and CS will evaluate vignettes twice according to the IASP criteria. There will be an interval of 1 month between the two measurements. One month later, the evaluation will be repeated. The investigators will design an Android application "Algo (s) rithm" to enter the questions of the algorithm. In the second phase, Algo (s)rithm app will use to evaluate patients with chronic pain (including patients with fibromyalgia) and healthy. The investigators will compare the result with PPT measurements in the same population.In the present study the inter-rater and test-retest reliability, criterion validity, construct validity will be examined.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Pain Central Sensitisation Nociplastic Pain

Interventions

Algo(s)rithm/ IASP clinical criteriaDIAGNOSTIC_TEST

IASP clinical criteria for identifying nociplastic pain. The criteria is completed by the healthcare professional and includes questions about the patient's clinical picture.

Pressure Pain ThresholdDIAGNOSTIC_TEST

The pain pressure threshold (PPT) is used to measure pain sensitivity in body areas. The test quantifies the minimum amount of pressure in a given area, during an increasing skin pressure stimulus, which is capable of altering the feeling of pressure in pain.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients 18-65 years * with pain \> 3months, intensity of at least 3 on a 0-10 numerical pain rating scale on most days * or patients with fibromyalgia (according to the "criteria for classification of fibromyalgia" by the American college of rheumatology (Wolfe et al 1990)). Exclusion Criteria: * Patients who follow a physical therapy program * Recent surgery or trauma * Pregnant women, * Patients with neurological disorders or systemic diseases

Locations (2)

Clinical Exercise Physiology and Rehabilitation Laboratory

Lamia, Central Greece, Greece

KAT Attica General Hospital

Athens, Greece

Outcomes

Primary Outcomes

IASP clinical criteria

IASP clinical criteria for indentifying nociplastic pain. The criteria are completed by the healthcare professional and includes questions about the patient's clinical picture.

Time frame: through study completion, an average of 1 year

Pressure Pain Thresholds PPT

The pain pressure threshold (PPT) is used to measure pain sensitivity in body areas. The test quantifies the minimum amount of pressure in a given area, during an increasing pressure of the skin, which is able to change the feeling of pressure in the pain. Measurements will be performed according to protocols used in previous studies.

Time frame: through study completion, an average of 1 year

Data from ClinicalTrials.gov

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