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

Completed

• Conditions: Chronic Pain; Central Sensitisation; Nociplastic Pain
• Interventions: Diagnostic Test: Algo(s)rithm/ IASP clinical criteria; Diagnostic Test: Pressure Pain Threshold

• Registration Number: NCT04730791
• Lead Sponsor: University of Thessaly

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-01-29
• Study Start: 2021-02-01
• Status Verified: 2024-12
• Primary Completion: 2024-12-02
• Study Completion: 2024-12-02
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Pressure Pain Threshold	Free pain participants
Chronic Pain Patients	Algo(s)rithm/ IASP clinical criteria	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.
Chronic Pain Patients	Pressure Pain Threshold	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.
Control Group	Algo(s)rithm/ IASP clinical criteria	Free pain participants

Primary Outcome Measures

Name	Time	Method
Pressure Pain Thresholds PPT	through study completion, an average of 1 year	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.
IASP clinical criteria	through study completion, an average of 1 year	IASP clinical criteria for indentifying nociplastic pain. The criteria are completed by the healthcare professional and includes questions about the patient's clinical picture.

Trial Locations

Locations (2)

KAT Attica General Hospital; 🇬🇷 Athens, Greece

Clinical Exercise Physiology and Rehabilitation Laboratory; 🇬🇷 Lamia, Sterea Ellada, Greece