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

University of Thessaly

Status: Completed

Conditions: Chronic Pain; Nociplastic Pain; Central Sensitisation

Treatments: Diagnostic Test: Pressure Pain Threshold; Diagnostic Test: Algo(s)rithm/ IASP clinical criteria

Study type: Observational

Funder types: Other

Identifiers

NCT04730791

4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

94 participants in 2 patient groups

Chronic Pain Patients

Description:

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.

Treatment:

Diagnostic Test: Algo(s)rithm/ IASP clinical criteria

Diagnostic Test: Pressure Pain Threshold

Control Group

Description:

Free pain participants

Treatment:

Diagnostic Test: Algo(s)rithm/ IASP clinical criteria

Diagnostic Test: Pressure Pain Threshold