Table 4. Inclusion and exclusion criteria for the cross-sectional cohorts for the DOLORisk protocol.
Inclusion criteria | Exclusion criteria | |
---|---|---|
Peripheral
neuropathic pain |
• ≥18 years with a diagnosis of peripheral neuropathy
based on a prior clinical assessment combined with supportive clinical investigations such as abnormal nerve conduction studies, reduced intraepidermal nerve or abnormal findings on quantitative sensory testing. • Symptoms highly suggestive of neuropathy that in the judgement of the clinical researcher are suitable for the study even if they do not fulfil other inclusion criteria. • Patients who do not fulfil any of the exclusion criteria. • Diabetes cohorts: Type 1 or Type 2 diabetes |
• Pregnant.
• Incapacity to give consent or to complete the study questionnaires due to insufficient language command or mental deficiencies. • Concurrent severe psychological or psychiatric disorders. • Moderate to severe pain from other causes that may confound assessment or reporting of pain (e.g. spinal canal stenosis). • Central nervous lesions, which may complicate somatosensory testing. • Patients who are in the opinion of the investigator unsuitable for participation in the study. |
Extreme
phenotypes |
• ≥16 years with a set of symptoms that resemble those
seen on Paroxysmal Extreme Pain Disorder, Familial Episodic Pain Syndrome or Erythromelalgia. • Existing diagnosis of Paroxysmal Extreme Pain Disorder or Familial Episodic Pain Syndrome or Erythromelalgia. • Reduced pain sensibility. • First degree relatives of patients who meet diagnostic criteria for Paroxysmal Extreme Pain Disorder, Familial Episodic Pain Syndrome, Erythromelalgia or inability to experience pain. • Patients who do not fulfil any of the exclusion criteria. |
• Pregnant.
• Incapacity to give consent or to complete the study questionnaires due to insufficient language command or mental deficiencies. • Concurrent severe psychological or psychiatric disorders, especially severe claustrophobia. • Moderate to severe pain arising as a consequence of other disorders causing pain but that are not associated with those mentioned before as channelopathies. • Central nervous system diseased that may complicate the somatosensory testing. • Patients who are in the opinion of the investigator unsuitable for participation in the study. • Treatment or topical capsaicin cream/ ointment or Lidocaine patch within 30 days prior to Day 1 on the skin area that will be tested. • Presence of oedema or any skin condition at the ankle level that may interfere with the microneurography procedure. |