The primary objective is to compare the one week test-retest reliability of the CutaStim electrode to self-adhesive conventional electrodes for pain sensitivity measurements.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Chronische pijn, centrale sensitisatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* eQST: Electrical pain threshold (EPT) [mA]
* Current pain: NRS of the current pain intensity.
* Past pain: Average NRS of the past seven days.
* Central Sensitization Symptoms: Central sensitization inventory (CSI) and
central sensitization questionnaire (CSQ)
* Neuropathic Pain symptoms: PainDETECT questionnaire (PD-Q)
Secondary outcome
* Patient characteristics (age, sex, BMI)
* Current medication intake
* ICD-code
Background summary
Chronic pain is a highly prevalent condition, with approximately 1 in 5
suffering from it in Europe. It has a large impact on the quality of life, but
also increases costs of global health care and absenteeism at work. A wide
spread increased sensitivity of the central nervous system to noxious
stimulation plays a major role in the development and maintenance of chronic
pain, and can be observed as a decreased pain threshold for electrocutaneous
stimulation. Although many clinical studies have demonstrated decreased
electrical pain thresholds (EPTs) in groups of chronic pain patients, the
measurement variability is still substantial due to the use of non-optimal
stimulation electrodes. The presently used electrodes cause a deep and
non-selective activation of both pain and non-pain related nerve fibers, which
hampers the patient in determining the pain threshold. Therefore, the CutaStim
electrode has been designed with improved selectivity towards pain related
nerve fibers in the superficial skin. We hypothesize that the CutaStim
electrode has a higher measurement reliability.
Study objective
The primary objective is to compare the one week test-retest reliability of the
CutaStim electrode to self-adhesive conventional electrodes for pain
sensitivity measurements.
Study design
Mono-center, cross-sectional study.
Study burden and risks
The participants will be asked to come to Roessingh for two session. During the
first session (max. 45 minutes), The familiarization starts after signed
informed consent has been obtained. During this session, the participant will
be randomized and training/practice with the EPT measurement will be performed.
The first EPT measurement will start right after the familiarization session.
During the second session (max. 20 minutes), which will be scheduled
approximately one week after the first session, another EPT measurement will be
done. The appointments of all included patients will be scheduled on days where
patients are already scheduled for a regular visit. Controls without chronic
pain syndrome are asked to visit RRC two times. All participants will be
compensated for the spent time. The participants will obtain no direct personal
benefit.
Drienerlolaan 5
Enschede 7522NB
NL
Drienerlolaan 5
Enschede 7522NB
NL
Listed location countries
Age
Inclusion criteria
Enrolled in a pain rehabilitation programme at Roessingh (Patients).
A signed, written informed consent. (Healthy controls and patients).
Age between 35 and 65 (Healthy controls and patients).
Exclusion criteria
- Participants refusal during the study (Healthy controls and patients)
- Average pain intensity of last 7 days of <2 (Patients only)
- Language problems (Healthy controls and patients)
- Skin problems (Healthy controls and patients)
- Unable to undergo eQST measurement (Healthy controls and patients)
- Diabetes (Healthy controls and patients)
- Implanted stimulation devices (Healthy controls and patients)
- Pregnancy (Healthy controls and patients)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60368.044.17 |
| OMON | NL-OMON28814 |