Validation of the Central Sensitisation Algorithm: Vignette Methods and Utilization to Patients With Chronic Pain
Study Details
Study Description
Brief Summary
This protocol will report on the validation process of the Central Sensitisation Algorithm. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 pain. The vignettes will feature patients with and without Central Sensitisation (CS). Initially, two experts will evaluate and characterize which vignettes concern patients with CS.
Next, a team of physiotherapists with knowledge of chronic pain and CS will evaluate vignettes twice: 1) according to their clinical reasoning and 2) according to the algorithm. There will be an interval of at least 2 weeks between the two measurements. One month later, the evaluation according to the Algorithm 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Specialized Algorithm for the categorization of Central Sensitisation. The algorithm is completed by the healthcare professional and includes questions about the patient's clinical picture.
Diagnostic Test: Pressure Pain Threshold
The pain pressure threshold (PPT) is used to measure the sensitivity of specific 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.
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| Control Group Free pain participants |
Diagnostic Test: Algo(s)rithm
Specialized Algorithm for the categorization of Central Sensitisation. The algorithm is completed by the healthcare professional and includes questions about the patient's clinical picture.
Diagnostic Test: Pressure Pain Threshold
The pain pressure threshold (PPT) is used to measure the sensitivity of specific 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.
|
Outcome Measures
Primary Outcome Measures
- Algo(s)rithm [through study completion, an average of 1 year]
Specialized Algorithm for the categorization of Central Sensitisation. The algorithm is completed by the healthcare professional and includes questions about the patient's clinical picture.
- Pressure Pain Thresholds PPT [through study completion, an average of 1 year]
The pain pressure threshold (PPT) is used to measure the sensitivity of specific 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 (Correa-Rodriquez et al. 2019; Coronado et al. 2018; Wang-Price et al. 2019; Jakorinne et al. 2018; Balaguier et al. 2016)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients 18-65 years
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with pain > 3months, intensity of at least 3 on a 0-10 numerical pain rating scale on most days
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or patients with fibromyalgia (according to the "criteria for classification of fibromyalgia" by the American college of rheumatology (Wolfe et al 1990)).
Exclusion Criteria:
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Patients who follow a physical therapy program
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Recent surgery or trauma
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Pregnant women,
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Patients with neurological disorders or systemic diseases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Exercise Physiology and Rehabilitation Laboratory | Lamia | Sterea Ellada | Greece | 35100 |
Sponsors and Collaborators
- Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
Investigators
- Study Chair: Eleni V Kapreli, MSc,PhD, Clinical Exercise Physiology & Rehabilitation Laboratory,University of Thessaly
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Review.
- 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. Review.
- Nijs J, Leysen L, Adriaenssens N, Aguilar Ferrándiz 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.
- 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. Review.
- 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.
- 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.
- Stacey D, Brière N, Robitaille H, Fraser K, Desroches S, Légaré 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.
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