Electrical Brain Responses During Processing of Nociceptive Stimuli Around Detection Threshold: an Explorative Study in Pain Patients

Recruiting

• Conditions: Chronische pijn, centrale sensitisatie, perifere sensitisatie; pain; 10012653; 10034606

• Registration Number: NL-OMON52779
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 440

Inclusion Criteria

Healthy subjects:
Age between 18 and 75.
No history of pathological pain.,
Healthy subjects (with lidocaine model):
Age between 18 and 65.
No history of pathological pain.
Patients:
FBSS:
Age between 18 and 65.,
CRPS-1 following injury in arm/hand:
Age between 18 and 65.,
Chronic painful DPN:
Age between 18 and 75.
Type 1 or 2 diabetes mellitus (DM); including subtypes.
An official diagnosis for diabetic polyneuropathy (DPN).
Duration of neuropathic pain >3 months (i.e. chronic).,
DM without neuropathic pain:
Age between 18 and 75.
Type 1 or 2 diabetes mellitus; including subtypes.
Absence of pathological pain complaints.
Sarcoidosis patients:
Age between 18 and 75
A score above 30 on the Small Fiber Neuropathy Screening List (SFNSL)
An experienced neurologist will judge whether there is a possibility /
probability of SFN
Obesity patients, pain-free:
Age between 18 and 75
BMI between 30 and 40 kg/m2
obesity patients with chronic arthrogenic pain:
Age between 18 an 75
BMI between 30 and 40 kg/m2
Chronic arthrogenic pain
Duration of arthrogenic pain at least 3 months
morbid obesity patients, pain-free (test-retest):
Age between 18 and 75
BMI at least 40 kg/m2
morbidobesity patients with chronic arthrogenic pain (test-retest):
Age between 18 an 75
BMI at least 40 kg/m2
Chronic arthrogenic pain
Duration of arthrogenic pain of at least 3 months
chronic arthrogenic pain patients:
BMI between 18.5 and 25 kg/m2
Chronic arthrogenic pain
Duration of arthrogenic pain of at least 3 months
CIPN patients:
Age between 18 and 75
Mammary carcinoma treated with Paclitaxel
FBSS-SCS patients:
Age between 18 en 65 years old
Spinal cord stimulator implanted at least 3 months ago
(Initial) Implantation considered successful, at least 50% pain relief
determined by NRS or VAS
FBSS-SCS-f patients:
Age between 18 en 65 years old
Spinal cord stimulator implanted at least 3 months ago
(Initial) Implantation considered successful, at least 50% pain relief
determined by NRS or VAS

Exclusion Criteria

General exclusion criteria:
Participant*s refusal during the study.
Communication problems or incapable of following the instructions.
Diabetes, except for diabetes mellitus patients.
Implanted stimulation device, except the neurostimulator in case of FBSS-SCS
patients
Pregnancy.
Consumption of alcohol or drugs within 24 hours before the experiment.
Medical history of chronic pain (for healthy subjects)
Skin on (at least) one of the hand dorsa non-intact, inflamed or otherwise
affected (e.g. injured, wounded).
Additional exclusion criteria for healthy subjects with lidocaine model:
Use of drugs based on or containing amyl nitrite, sodium nitrite, sodium
thiosulfate, epinephrine and/or prilocaine (topical)
(Known) hypersensitivity to lidocaine or other amide-type local anaesthetics,
with allergic reactions such as urticaria or anaphylaxis.
(Known) hypersensitivity to any other component in the lidocaine or placebo
patch, with allergic reactions such as urticaria or anaphylaxis.
Additional exclusion criteria for the patients with chronic painful DPN:
Chronic pain complaints other than due to DPN.
Known possible other causes of polyneuropathy.
Central or peripheral nerve disorders other than diabetic polyneuropathy (e.g.
spinal stenosis, radiculopathy, multiple sclerosis, carpal tunnel syndrome).
Additional exclusion criteria for the diabetes patients without neuropathic
pain:
Central or peripheral nerve disorders other than diabetic polyneuropathy (e.g.
spinal stenosis, radiculopathy, multiple sclerosis, carpal tunnel syndrome).
Additional exclusion criteria for sarcoidosis patients:
Severe or chronic non-neuropathic pain complaints.
Known possible other causes of polyneuropathy.
Central or peripheral nerve disorders other than sarcoidosis with symptoms of
SFN (e.g. spinal stenosis, radiculopathy, multiple sclerosis, carpal tunnel
syndrome).
Additional exclusion criteria for (morbid) obesity group with/without chronic
pain and the chronic arthrogenic pain group:
Underwent bariatric surgery (except in the retest of the morbid obesity groups)
Rheumatoid arhritis
Chronic painful form of diabetic polyneuropathy
Additional exclusion criteria for CIPN patients:
Severe or chronic non-neuropathic pain complaints.
Known possible other causes of polyneuropathy.
Central or peripheral nerve disorders other than CIPN with symptoms of SFN
(e.g. spinal stenosis, radiculopathy, multiple sclerosis, carpal tunnel
syndrome).
Additional exclusion criterion for HC-f group and FBSS-SCS-f patients:
Skin on (at least) one of the foot dorsa non-intact, inflamed or otherwise
affected (e.g. injured, wounded).

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The nociceptive detection threshold<br /><br>EEG signals</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Current pain (NRS)<br /><br>Average pain in the last seven days (NRS)<br /><br>Questionnaire about symptoms of central sensitization: central sensitization<br /><br>inventory (CSI)<br /><br>Current medication intake<br /><br>Participant characteristics: age, sex, BMI, handedness<br /><br>Outcomes of neurological examination of the back of the hands: anamnesis<br /><br>sensory integrity and physical examination (pin-prick test and test for light<br /><br>touch) (for healthy controls with lidocaine model and diabetic patients)<br /><br>DN4<br /><br>SFNSL<br /><br>Questionnaire about daily functionality: Oswestry Disability Index (ODI)</p><br>