No registrations found.
ID
Source
Brief title
Health condition
chronic pain, central sensitization, pain rehabilitation, pelvic pain, back pain.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Central Sensitization Inventory
Secondary outcome
None
Background summary
Central sensitization (CS) is a state of hyper responsiveness of the central nervous system. According to Woolf, CS is “operationally defined as an amplification of neural signaling within the central nervous system that elicits pain hypersensitivity.” In clinical practice, CS manifests as pain hypersensitivity, particularly dynamic tactile allodynia, secondary punctate or pressure hyperalgesia, longer aftersensations, and enhanced temporal summation. CS seems to be (part of) the explanation for pain in several clinically well-known chronic disorders such as fibromyalgia, chronic pelvic pain, chronic low back pain, osteoarthritis, temporomandibular disorders, chronic whiplash, and chronic patellar tendinopathy.
The Central Sensitisation Inventory (CSI) has been used to identify patients with signs possibly related to central sensitisation. In Dutch the CSI is validated for a group of chronic pain patients (n=368). But no analysis has been done on age, sex and type of pain in relation with the CSI. Therefor we want to analyse these factors in relation with the CSI in a larger group of chronic pain patients (at least n = 1500). The original CSI has an established cut-off value of 40 out of 100. This cut-off value is based on 121 patients with chronic pain and 129 non-patient sample (undergraduate students not currently in treatment for chronic pain). We want to re-establish a cut-off value for the CSI based on a larger group of chronic pain patients (at least n=1500) and healthy, pain-free volunteers. The healthy, pain-free volunteers will not have pain, pain medication, pain treatment, antidepressants, anti-epileptics and no CSS reported in the CSI part B.
The primary aim of this study is to re-establish the cut-off value for the CSI score based on the presence of CSS. Our secondary aim is to identify sex, age, weight, height, BMI, number of reported CS syndromes, quality of life, pain catastrophizing, pain disability, pain severity, pain location, and pain disorders as possible predictors for the CSI score. Our third aim is to establish possible alternative cut-off values dependent on sex or one or more of the other factors found in our secondary analysis as predictors.
Study objective
The hypothesis is that there might be a different cut-off value when using a larger sample.
Sex, age, weight, height, BMI, number of reported CS syndromes, quality of life, pain catastrophizing, pain disability, pain severity, pain location, and pain disorders can predict the CSI score.
Study design
For patients:
Intake
Follow-up (if available in medical record, at time points 3, 6 and 12 months)
For healthy volunteers:
One moment of collecting questionnaires
Intervention
Care as Usual for patients, not applicable for healty volunteers
Inclusion criteria
Patients:
- Patients who visited the UMCG pain center between November 1, 2017 and October 1, 2021
Healthy volunteers
- Self-reported healthy and pain-free
Exclusion criteria
Age younger than 18 years
Healthy volunteers:
- using pain medication
- undergoing treatment for pain
- reporting a CSS diagnosis in the CSI part B
- reporting the use of antidepressants at moment of completing questionnaire
- reporting the use of anti-epileptics at the moment of completing questionnaire
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9241 |
| Other | METc Univeristy Medical Center Groningen : METc 2020/284 and METc 2021/361, non-WMO confirmation |