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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52779
Enrollment
440
Registered
2018-08-27
Start date
2018-10-02
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronische pijn, centrale sensitisatie, perifere sensitisatie pain

Interventions

None listed

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
The nociceptive detection threshold EEG signals

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)