DOLORisk: Research on Risk Factors and Determinants for Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888455
• Other study ID #: 633491 - DOLORisk WP4
• Status: Completed
• Start date: June 2015
• Est. completion date: June 2019

Study information

• Verified date: November 2022
• Source: University of Kiel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1550
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Polyneuropathy

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Diagnostic Test:
• Quantitative sensory testing (QST)
Demographic data, pain characteristics, health status, emotional well-being, personality and lifestyle are assessed by questionnaires. Additionally, all patients underwent a clinical neurological examination and quantitative sensory testing (QST) according to the German Research Network on Neuropathic Pain (DFNS).

Locations

Country	Name	City	State
Germany	University of Kiel	Kiel	Schleswig-Holstein

Sponsors (8)

Lead Sponsor	Collaborator
University of Kiel	Aarhus University Hospital, Horizon 2020 - European Commission, Imperial College London, Institut National de la Santé Et de la Recherche Médicale, France, Technion, Israel Institute of Technology, University of Aarhus, University of Oxford

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Pascal MMV, Themistocleous AC, Baron R, Binder A, Bouhassira D, Crombez G, Finnerup NB, Gierthmühlen J, Granovsky Y, Groop L, Hebert HL, Jensen TS, Johnsen K, McCarthy MI, Meng W, Palmer CNA, Rice ASC, Serra J, Solà R, Yarnitsky D, Smith BH, Attal N, Bennett DLH. DOLORisk: study protocol for a multi-centre observational study to understand the risk factors and determinants of neuropathic pain. Version 2. Wellcome Open Res. 2019 Feb 1 [revised 2019 Jan 1];3:63. doi: 10.12688/wellcomeopenres.14576.2. eCollection 2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Pain measured by Pain severity	Measurement on NRS [NRS 0-10]	through study completion, an average of 2 years
Secondary	Severity of Neuropathy measured by Toronto Neuropathy scale	Total Score [0-19 points] from history and clinical examination	through study completion, an average of 2 years
Secondary	Somatosensory phenotype measured by Quantitative sensory testing	Assessment of somatosensory phenotype with the protocol of the German REsearch Network of Neuropathic Pain (DFNS)	through study completion, an average of 2 years
Secondary	Emotional well-being	assessed by anxiety PROMIS Short Form v1.0 -Anxiety 6a, Depression 6a, Fatigue and Sleep	through study completion, an average of 2 years
Secondary	Personality characteristics	assessed by Ten-Item Personality Inventory and International Personality Item Pool's	through study completion, an average of 2 years
Secondary	Pain Catastrophizing	assessed by Pain Catastrophizing scale (PCS) total score [0-52 points]	through study completion, an average of 2 years
Secondary	Presence of family history of chronic pain	Presence of pain in family	through study completion, an average of 2 years

External Links

•   Study protocol