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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04730791
Enrollment
94
Registered
2021-01-29
Start date
2021-02-01
Completion date
2024-12-02
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Central Sensitisation, Nociplastic Pain

Keywords

Algo(s)rithm, Vignette Method, Central Sensitisation, Chronic Pain Categorization, IASP criteria, Nociplastic pain

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.

Interventions

DIAGNOSTIC_TESTAlgo(s)rithm/ IASP clinical criteria

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

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.

Sponsors

KAT General Hospital
CollaboratorOTHER
University of Thessaly
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
IASP clinical criteriathrough study completion, an average of 1 yearIASP clinical criteria for indentifying nociplastic pain. The criteria are completed by the healthcare professional and includes questions about the patient's clinical picture.
Pressure Pain Thresholds PPTthrough study completion, an average of 1 yearThe 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.

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026