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Clinical Trials/NL-OMON52779
NL-OMON52779RecruitingNot Applicable

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

Sint Antonius Ziekenhuis0 sites440 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
440
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 to 64 (—)

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.
  • •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
  • +6 more not shown

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
  • •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
  • •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
  • •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
  • •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).

Investigators

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