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

NCT04730791 | Completed

• 1 other identifier: 4
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain; Central Sensitisation; Nociplastic Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

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

Control Group

Free pain participants

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

Interventions

Algo(s)rithm/ IASP clinical criteria 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.

Chronic Pain Patients; Control Group

Pressure Pain Threshold 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.

Chronic Pain Patients; Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The measurements will be performed in the research laboratory of Clinical Exercise Physiology and Rehabilitation (CeprLab) of the University of Thessaly. The sample will consist of people who will have access to the laboratory regardless of the area of residence. The participants will be informed through the media (social networking pages, the official page of the University, the official page of the CeprLab, brochures that will be sent to physiotherapists and the Panhellenic Association of Physiotherapists).

You may qualify if:

• 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)).

You may not qualify if:

• Patients who follow a physical therapy program
• Recent surgery or trauma
• Pregnant women,
• Patients with neurological disorders or systemic diseases

Sponsors & Collaborators

• University of Thessaly: lead
• KAT General Hospital: collaborator

Study Sites (2)

Clinical Exercise Physiology and Rehabilitation Laboratory

Lamia, Central Greece, 35100, Greece

Location

KAT Attica General Hospital

Athens, Greece

Location

Related Publications (10)

• 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.

  PMID: 21471812 BACKGROUND

• 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.

  PMID: 26000680 BACKGROUND

• 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.

  PMID: 28768437 BACKGROUND

• 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.

  PMID: 29522121 BACKGROUND

• 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.

  PMID: 27142228 BACKGROUND

• 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.

  PMID: 30858291 BACKGROUND

• 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.

  PMID: 22534654 BACKGROUND

• 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.

  PMID: 24766619 BACKGROUND

• 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.

  PMID: 34361986 BACKGROUND

• 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.

  PMID: 33974577 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Nociplastic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eleni V Kapreli, MSc,PhD

  Clinical Exercise Physiology & Rehabilitation Laboratory,University of Thessaly

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: February 1, 2021
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)