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

NCT ID: NCT04730791

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2024-12-02

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.

Conditions

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Chronic Pain Central Sensitisation Nociplastic Pain

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic Pain Patients

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.

Algo(s)rithm/ IASP clinical criteria

Intervention Type DIAGNOSTIC_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 Threshold

Intervention Type DIAGNOSTIC_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.

Control Group

Free pain participants

Algo(s)rithm/ IASP clinical criteria

Intervention Type DIAGNOSTIC_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 Threshold

Intervention Type DIAGNOSTIC_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.

Interventions

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Algo(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.

Intervention Type DIAGNOSTIC_TEST

Pressure Pain Threshold

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.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KAT General Hospital

OTHER

Sponsor Role collaborator

University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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Paraskevi Bilika

Study Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eleni V Kapreli, MSc,PhD

Role: STUDY_CHAIR

Clinical Exercise Physiology & Rehabilitation Laboratory,University of Thessaly

Locations

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Clinical Exercise Physiology and Rehabilitation Laboratory

Lamia, Central Greece, Greece

Site Status

KAT Attica General Hospital

Athens, , Greece

Site Status

Countries

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Greece

References

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Smart KM, Blake C, Staines A, Doody C. The Discriminative validity of "nociceptive," "peripheral neuropathic," and "central sensitization" as mechanisms-based classifications of musculoskeletal pain. Clin J Pain. 2011 Oct;27(8):655-63. doi: 10.1097/AJP.0b013e318215f16a.

Reference Type BACKGROUND
PMID: 21471812 (View on PubMed)

Nijs J, Apeldoorn A, Hallegraeff H, Clark J, Smeets R, Malfliet A, Girbes EL, De Kooning M, Ickmans K. Low back pain: guidelines for the clinical classification of predominant neuropathic, nociceptive, or central sensitization pain. Pain Physician. 2015 May-Jun;18(3):E333-46.

Reference Type BACKGROUND
PMID: 26000680 (View on PubMed)

Lluch E, Nijs J, Courtney CA, Rebbeck T, Wylde V, Baert I, Wideman TH, Howells N, Skou ST. Clinical descriptors for the recognition of central sensitization pain in patients with knee osteoarthritis. Disabil Rehabil. 2018 Nov;40(23):2836-2845. doi: 10.1080/09638288.2017.1358770. Epub 2017 Aug 2.

Reference Type BACKGROUND
PMID: 28768437 (View on PubMed)

Levesque A, Riant T, Ploteau S, Rigaud J, Labat JJ; Convergences PP Network. Clinical Criteria of Central Sensitization in Chronic Pelvic and Perineal Pain (Convergences PP Criteria): Elaboration of a Clinical Evaluation Tool Based on Formal Expert Consensus. Pain Med. 2018 Oct 1;19(10):2009-2015. doi: 10.1093/pm/pny030.

Reference Type BACKGROUND
PMID: 29522121 (View on PubMed)

Nijs J, Leysen L, Adriaenssens N, Aguilar Ferrandiz ME, Devoogdt N, Tassenoy A, Ickmans K, Goubert D, van Wilgen CP, Wijma AJ, Kuppens K, Hoelen W, Hoelen A, Moloney N, Meeus M. Pain following cancer treatment: Guidelines for the clinical classification of predominant neuropathic, nociceptive and central sensitization pain. Acta Oncol. 2016 Jun;55(6):659-63. doi: 10.3109/0284186X.2016.1167958. Epub 2016 May 4.

Reference Type BACKGROUND
PMID: 27142228 (View on PubMed)

Nijs J, Polli A, Willaert W, Malfliet A, Huysmans E, Coppieters I. Central sensitisation: another label or useful diagnosis? Drug Ther Bull. 2019 Apr;57(4):60-63. doi: 10.1136/dtb.2018.000035. Epub 2019 Mar 11. No abstract available.

Reference Type BACKGROUND
PMID: 30858291 (View on PubMed)

Smart KM, Blake C, Staines A, Thacker M, Doody C. Mechanisms-based classifications of musculoskeletal pain: part 1 of 3: symptoms and signs of central sensitisation in patients with low back (+/- leg) pain. Man Ther. 2012 Aug;17(4):336-44. doi: 10.1016/j.math.2012.03.013. Epub 2012 Apr 23.

Reference Type BACKGROUND
PMID: 22534654 (View on PubMed)

Stacey D, Briere N, Robitaille H, Fraser K, Desroches S, Legare F. A systematic process for creating and appraising clinical vignettes to illustrate interprofessional shared decision making. J Interprof Care. 2014 Sep;28(5):453-9. doi: 10.3109/13561820.2014.911157. Epub 2014 Apr 28.

Reference Type BACKGROUND
PMID: 24766619 (View on PubMed)

Nijs J, Lahousse A, Kapreli E, Bilika P, Saracoglu I, Malfliet A, Coppieters I, De Baets L, Leysen L, Roose E, Clark J, Voogt L, Huysmans E. Nociplastic Pain Criteria or Recognition of Central Sensitization? Pain Phenotyping in the Past, Present and Future. J Clin Med. 2021 Jul 21;10(15):3203. doi: 10.3390/jcm10153203.

Reference Type BACKGROUND
PMID: 34361986 (View on PubMed)

Kosek E, Clauw D, Nijs J, Baron R, Gilron I, Harris RE, Mico JA, Rice ASC, Sterling M. Chronic nociplastic pain affecting the musculoskeletal system: clinical criteria and grading system. Pain. 2021 Nov 1;162(11):2629-2634. doi: 10.1097/j.pain.0000000000002324. No abstract available.

Reference Type BACKGROUND
PMID: 33974577 (View on PubMed)

Other Identifiers

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4

Identifier Type: -

Identifier Source: org_study_id