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. 2019 Feb 1;3:63. Originally published 2018 May 29. [Version 2] doi: 10.12688/wellcomeopenres.14576.2

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.