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Completed

NCT Number: NCT04888455

DOLORisk: Research on Risk Factors and Determinants for Neuropathic Pain

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathy, Painful Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kiel

Kiel, Schleswig-Holstein, 24105, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quantitative sensory testing (QST)

Diagnostic Test

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).

Other names: Different Questionnaires

Primary outcomes

  1. Presence of Pain measured by Pain severity

    Time frame: through study completion, an average of 2 years

    Measurement on NRS [NRS 0-10]

Secondary outcomes

  1. Severity of Neuropathy measured by Toronto Neuropathy scale

    Time frame: through study completion, an average of 2 years

    Total Score [0-19 points] from history and clinical examination

  2. Somatosensory phenotype measured by Quantitative sensory testing

    Time frame: through study completion, an average of 2 years

    Assessment of somatosensory phenotype with the protocol of the German REsearch Network of Neuropathic Pain (DFNS)

  3. Emotional well-being

    Time frame: through study completion, an average of 2 years

    assessed by anxiety PROMIS Short Form v1.0 -Anxiety 6a, Depression 6a, Fatigue and Sleep

  4. Personality characteristics

    Time frame: through study completion, an average of 2 years

    assessed by Ten-Item Personality Inventory and International Personality Item Pool's

  5. Pain Catastrophizing

    Time frame: through study completion, an average of 2 years

    assessed by Pain Catastrophizing scale (PCS) total score [0-52 points]

  6. Presence of family history of chronic pain

    Time frame: through study completion, an average of 2 years

    Presence of pain in family

Sponsors and collaborators

Lead sponsor

University of Kiel

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 17, 2021
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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