Clinical trial NCT04730791: Reliability and Validity of the IASP Clinical Criteria for Identifying Patients with Nociplastic Pain
Official title: Reliability and Validity of the IASP Clinical Criteria for Identifying Patients with Nociplastic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Central Sensitisation
Nociplastic Pain
Keywords: Algo(s)rithm
Vignette Method
Central Sensitisation
Chronic Pain Categorization
IASP criteria
Nociplastic pain
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: KAT General Hospital
First posted: 2021-01-29
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: IASP clinical criteria
timeFrame: through study completion, an average of 1 year
measure: Pressure Pain Thresholds PPT
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: Clinical Exercise Physiology and Rehabilitation Laboratory
state: Sterea Ellada
city: Athens
country: Greece
facility: KAT Attica General Hospital
Study officials:
affiliation: Clinical Exercise Physiology & Rehabilitation Laboratory,University of Thessaly
name: Eleni V Kapreli, MSc,PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.