DOLORisk: Research on Risk Factors and Determinants for Neuropathic Pain
- Conditions
- Neuropathic Pain
- Interventions
- Diagnostic Test: Quantitative sensory testing (QST)
- Registration Number
- NCT04888455
- Lead Sponsor
- University of Kiel
- Brief Summary
Patients with neuropathic pain of multiple etiologies and a control cohort of patients with the same neuropathic entities who did not develop neuropathic pain are examined clinically, phenotyped with QST and questionnaires. Both groups are analyzed in order to find risk factors for painful neuropathy.
- Detailed Description
Patients with probable (presence of a combination of symptoms and signs of neuropathy include any two or more of the following: neuropathic symptoms, decreased distal sensation, or unequivocally decreased or absent ankle reflexes) or confirmed (presence of an abnormality of NC or validated measure of small fiber neuropathy with class 1 evidence with corresponding symptoms) neuropathy are included. Patients are then further divided into those with painful and painless neuropathy according to the NeuPSIG algorithm. Patients with probable or definite neuropathic pain are classified as painful neuropathy, those with unlikely neuropathic pain classified as painless neuropathy (with concomitant nociceptive pain of other origin, e.g. headache etc.). Patients with possible neuropathic pain are excluded from analysis as are patients with skin lesions or dermatological disorders in the areas to be tested upon QST, with any painful or neurological comorbidity that could otherwise influence testing results such as vascular disease, radiculopathy, spinal canal stenosis etc. Inclusion was restricted to patients with polyneuropathy to make the investigated patient sample as homogenous as possible.
Age, gender, BMI, ethnicity, years in education, family history of chronic pain, etiology of neuropathy, presence of early traumatic events and hospital admissions, smoking and alcohol habits, pain characteristics (von Korff, BPSI, NPSI), emotional well-being (PROMIS depression/ anxiety), personality (TIPI, IPIP, PCS), severity of neuropathy are assessed and QST performed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1550
- Diagnosis of Polyneuropathy
- Patients with polyneuropathy and possible neuropathic pain
- Patients with skin lesions or dermatological disorders in the areas to be tested upon QST
- Patients with any painful or neurological comorbidity that could otherwise influence testing results such as vascular disease, radiculopathy, spinal canal stenosis etc.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Painful neuropathy Quantitative sensory testing (QST) Patients with presence of probable (presence of a combination of symptoms and signs of neuropathy include any two or more of the following: neuropathic symptoms, decreased distal sensation, or unequivocally decreased or absent ankle reflexes) or confirmed (presence of an abnormality of NC or validated measure of small fiber neuropathy with class 1 evidence with corresponding symptoms) neuropathy AND with probable or definite neuropathic pain according to the NeuPSIG algorithm. Painless neuropathy Quantitative sensory testing (QST) Patients with presence of probable (presence of a combination of symptoms and signs of neuropathy include any two or more of the following: neuropathic symptoms, decreased distal sensation, or unequivocally decreased or absent ankle reflexes) or confirmed (presence of an abnormality of NC or validated measure of small fiber neuropathy with class 1 evidence with corresponding symptoms) neuropathy AND with unlikely neuropathic pain according to the NeuPSIG algorithm.
- Primary Outcome Measures
Name Time Method Presence of Pain measured by Pain severity through study completion, an average of 2 years Measurement on NRS \[NRS 0-10\]
- Secondary Outcome Measures
Name Time Method Severity of Neuropathy measured by Toronto Neuropathy scale through study completion, an average of 2 years Total Score \[0-19 points\] from history and clinical examination
Somatosensory phenotype measured by Quantitative sensory testing through study completion, an average of 2 years Assessment of somatosensory phenotype with the protocol of the German REsearch Network of Neuropathic Pain (DFNS)
Emotional well-being through study completion, an average of 2 years assessed by anxiety PROMIS Short Form v1.0 -Anxiety 6a, Depression 6a, Fatigue and Sleep
Personality characteristics through study completion, an average of 2 years assessed by Ten-Item Personality Inventory and International Personality Item Pool's
Pain Catastrophizing through study completion, an average of 2 years assessed by Pain Catastrophizing scale (PCS) total score \[0-52 points\]
Presence of family history of chronic pain through study completion, an average of 2 years Presence of pain in family
Trial Locations
- Locations (1)
University of Kiel
🇩🇪Kiel, Schleswig-Holstein, Germany