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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reliability and Validity of the IASP Clinical Criteria for Identifying Patients With Nociplastic Pain

Conditions
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Chronic Pain, Central Sensitisation, Nociplastic Pain

Intervention / Treatment
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* Diagnostic Test: Algo(s)rithm/ IASP clinical criteria
* Diagnostic Test: Pressure Pain Threshold


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Pain Patients<br>Adult patients 18-65 years, with chronic pain lasting for 3 or more months, with a pain intensity of at least 3 on a 0-10 numerical pain rating scale on most days. | Diagnostic Test: Algo(s)rithm/ IASP clinical criteria<br>* IASP clinical criteria for identifying nociplastic pain. The criteria is completed by the healthcare professional and includes questions about the patient's clinical picture.<br>Diagnostic Test: Pressure Pain Threshold<br>* 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.<br>|
| Control Group<br>Free pain participants | Diagnostic Test: Algo(s)rithm/ IASP clinical criteria<br>* IASP clinical criteria for identifying nociplastic pain. The criteria is completed by the healthcare professional and includes questions about the patient's clinical picture.<br>Diagnostic Test: Pressure Pain Threshold<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Algo(s)rithm, Vignette Method, Central Sensitisation, Chronic Pain Categorization, IASP criteria, Nociplastic pain