Chronic PainNCT04730791
Reliability and Validity of the IASP Clinical Criteria for Identifying Patients with Nociplastic Pain
An observational study of Chronic Pain and Central Sensitisation, run by University of Thessaly at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Central Sensitisation, Nociplastic Pain
- What is being tested?
- Algo(s)rithm/ IASP clinical criteria and Pressure Pain Threshold
- How many people
- 94 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Feb 2021to 2 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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)).
Who cannot join
- Patients who follow a physical therapy program
- Recent surgery or trauma
- Pregnant women,
- Patients with neurological disorders or systemic diseases
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
KAT Attica General Hospital
Athens
Clinical Exercise Physiology and Rehabilitation Laboratory
Lamia, Central Greece, 35100
About this study
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.
Read the 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.
- Conditions
- Chronic Pain, Central Sensitisation, Nociplastic Pain
- Being tested
- Algo(s)rithm/ IASP clinical criteria, Pressure Pain Threshold
- Keywords
- Algo(s)rithm, Vignette Method, Central Sensitisation, Chronic Pain Categorization, IASP criteria, Nociplastic pain
- Medical subject headings
- Chronic Pain, Nociplastic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algo(s)rithm/ IASP clinical criteriaDiagnostic 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 ThresholdDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Algo(s)rithm/ IASP clinical criteria; Diagnostic Test: Pressure Pain Threshold | |
| Control Group | Free pain participants Receives: Diagnostic Test: Algo(s)rithm/ IASP clinical criteria; Diagnostic Test: Pressure Pain Threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Feb 2021
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- KAT General Hospital
- Responsible party
- Principal investigator, Paraskevi Bilika, University of Thessaly
- Investigators
- Eleni V Kapreli, MSc,PhD, Study chair, Clinical Exercise Physiology & Rehabilitation Laboratory,University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730791
- Sponsor's protocol ID
- 4
- Status last verified
- Dec 2024
- First submitted
- 26 Jan 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21471812Nijs 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.
PubMed 26000680Lluch 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.
PubMed 28768437Levesque 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.
PubMed 29522121Nijs 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.
PubMed 27142228Nijs 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.
PubMed 30858291Smart 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.
PubMed 22534654Stacey 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.
PubMed 24766619Nijs 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.
PubMed 34361986Kosek 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.
PubMed 33974577
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the IASP Clinical Criteria for Identifying Patients with Nociplastic Pain
- ClinicalTrials.gov ID
- NCT04730791
- Acronym / sponsor ID
- 4
- Conditions
- Chronic Pain, Central Sensitisation, Nociplastic Pain
- Keywords
- Algo(s)rithm, Vignette Method, Central Sensitisation, Chronic Pain Categorization, IASP criteria, Nociplastic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- KAT General Hospital
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Pain Patients | – | Diagnostic Test: Algo(s)rithm/ IASP clinical criteria, Diagnostic Test: Pressure Pain ThresholdAdult 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. |
| Control Group | – | Diagnostic Test: Algo(s)rithm/ IASP clinical criteria, Diagnostic Test: Pressure Pain ThresholdFree pain participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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)).
Key exclusion criteria (4 listed)
- Patients who follow a physical therapy program
- Recent surgery or trauma
- Pregnant women,
- Patients with neurological disorders or systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algo(s)rithm/ IASP clinical criteriaIASP clinical criteria for identifying nociplastic pain. The criteria is completed by the healthcare professional and includes questions about the patient's clinical picture. | Diagnostic test | Chronic Pain Patients, Control Group |
| Pressure Pain ThresholdThe 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. | Diagnostic test | Chronic Pain Patients, Control Group |
Primary outcome
IASP clinical criteria
Time frame: through study completion, an average of 1 year
IASP 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 PPT
Time frame: through study completion, an average of 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Background: PubMed 21471812Smart 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.
- Background: PubMed 26000680Nijs 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.
- Background: PubMed 28768437Lluch 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.
- Background: PubMed 29522121Levesque 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.
- Background: PubMed 27142228Nijs 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.
- Background: PubMed 30858291Nijs 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.
- Background: PubMed 22534654Smart 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.
- Background: PubMed 24766619Stacey 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.
- Background: PubMed 34361986Nijs 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.
- Background: PubMed 33974577Kosek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleni V Kapreli, MSc,PhD study chair
Clinical Exercise Physiology & Rehabilitation Laboratory,University of Thessaly
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Central Sensitisation, run by University of Thessaly at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IASP clinical criteria (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04730791, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.