Neuropathic PainNCT04888455
DOLORisk: Research on Risk Factors and Determinants for Neuropathic Pain
An observational study of Neuropathic Pain, run by University of Kiel at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Quantitative sensory testing (QST)
- How many people
- 1,550 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Jun 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In- and outpatients 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. Patients are then further divided into those with painful and painless neuropathy according to the NeuPSIG algorithm.
Who may be able to join
- Diagnosis of Polyneuropathy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Sensory Phenotype on the Risk of Developing 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.
Read the 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.
- Conditions
- Neuropathic Pain
- Being tested
- Quantitative sensory testing (QST)
- Keywords
- pain prevention, painful neuropathy,, painless neuropathy, QST, patient-reported outcomes, PRO
- Medical subject headings
- Neuralgia, Neuropathy, Painful
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative sensory testing (QST)Diagnostic test
Also called Different Questionnaires
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).
| Study group | Role | What they receive |
|---|---|---|
| Painful neuropathy | 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. Receives: Diagnostic Test: Quantitative sensory testing (QST) | |
| Painless neuropathy | 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. Receives: Diagnostic Test: Quantitative sensory testing (QST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Pain measured by Pain severity
Measurement on NRS [NRS 0-10]
Measured: through study completion, an average of 2 years
Secondary outcomes (6)
Severity of Neuropathy measured by Toronto Neuropathy scale
Total Score [0-19 points] from history and clinical examination
Measured: through study completion, an average of 2 years
Somatosensory phenotype measured by Quantitative sensory testing
Assessment of somatosensory phenotype with the protocol of the German REsearch Network of Neuropathic Pain (DFNS)
Measured: through study completion, an average of 2 years
Emotional well-being
assessed by anxiety PROMIS Short Form v1.0 -Anxiety 6a, Depression 6a, Fatigue and Sleep
Measured: through study completion, an average of 2 years
Personality characteristics
assessed by Ten-Item Personality Inventory and International Personality Item Pool's
Measured: through study completion, an average of 2 years
Pain Catastrophizing
assessed by Pain Catastrophizing scale (PCS) total score [0-52 points]
Measured: through study completion, an average of 2 years
Presence of family history of chronic pain
Presence of pain in family
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study startJun 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,550 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon 2020 - European Commission, Institut National de la Santé Et de la Recherche Médicale, France, University of Oxford, Imperial College London, Technion, Israel Institute of Technology, University of Aarhus, Aarhus University Hospital
- Responsible party
- Principal investigator, Janne Gierthmuhlen, University of Kiel
- Investigators
- David Bennett, Prof., Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888455
- Sponsor's protocol ID
- 633491 - DOLORisk WP4
- Status last verified
- Nov 2022
- First submitted
- 5 May 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pascal MMV, Themistocleous AC, Baron R, Binder A, Bouhassira D, Crombez G, Finnerup NB, Gierthmuhlen J, Granovsky Y, Groop L, Hebert HL, Jensen TS, Johnsen K, McCarthy MI, Meng W, Palmer CNA, Rice ASC, Serra J, Sola 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. Wellcome Open Res. 2019 Feb 1;3:63. doi: 10.12688/wellcomeopenres.14576.2. eCollection 2018.
PubMed 30756091Gierthmuhlen J, Attal N, Baskozos G, Bennedsgaard K, Bennett DL, Bouhassira D, Crombez G, Finnerup NB, Granovsky Y, Jensen TS, John J, Kennes LN, Laycock H, Pascal MMV, Rice ASC, Shafran-Topaz L, Themistocleous AC, Yarnitsky D, Baron R. What is associated with painful polyneuropathy? A cross-sectional analysis of symptoms and signs in patients with painful and painless polyneuropathy. Pain. 2024 Dec 1;165(12):2888-2899. doi: 10.1097/j.pain.0000000000003310. Epub 2024 Jul 3.
PubMed 38968400
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain
- ClinicalTrials.gov ID
- NCT04888455
- Acronym / sponsor ID
- 633491 - DOLORisk WP4
- Conditions
- Neuropathic Pain
- Keywords
- pain prevention, painful neuropathy,, painless neuropathy, QST, patient-reported outcomes, PRO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,550 participants (actual)
- Lead sponsor
- University of KielUniversity, hospital or other
- Collaborators
- Horizon 2020 - European Commission, Institut National de la Santé Et de la Recherche Médicale, France, University of Oxford, Imperial College London, Technion, Israel Institute of Technology, University of Aarhus, Aarhus University Hospital
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Painful neuropathy | – | Diagnostic Test: 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 | – | Diagnostic Test: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In- and outpatients 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. Patients are then further divided into those with painful and painless neuropathy according to the NeuPSIG algorithm.
Key inclusion criteria (1 listed)
- Diagnosis of Polyneuropathy
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative sensory testing (QST)Also: Different QuestionnairesDemographic 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). | Diagnostic test | Painful neuropathy, Painless neuropathy |
Primary outcome
Presence of Pain measured by Pain severity
Time frame: through study completion, an average of 2 years
Measurement on NRS [NRS 0-10]
6 secondary outcomes
Severity of Neuropathy measured by Toronto Neuropathy scale
Time frame: through study completion, an average of 2 years
Somatosensory phenotype measured by Quantitative sensory testing
Time frame: through study completion, an average of 2 years
Emotional well-being
Time frame: through study completion, an average of 2 years
Personality characteristics
Time frame: through study completion, an average of 2 years
Pain Catastrophizing
Time frame: through study completion, an average of 2 years
Presence of family history of chronic pain
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 30756091Pascal MMV, Themistocleous AC, Baron R, Binder A, Bouhassira D, Crombez G, Finnerup NB, Gierthmuhlen J, Granovsky Y, Groop L, Hebert HL, Jensen TS, Johnsen K, McCarthy MI, Meng W, Palmer CNA, Rice ASC, Serra J, Sola 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. Wellcome Open Res. 2019 Feb 1;3:63. doi: 10.12688/wellcomeopenres.14576.2. eCollection 2018.
- Derived from this study: PubMed 38968400Gierthmuhlen J, Attal N, Baskozos G, Bennedsgaard K, Bennett DL, Bouhassira D, Crombez G, Finnerup NB, Granovsky Y, Jensen TS, John J, Kennes LN, Laycock H, Pascal MMV, Rice ASC, Shafran-Topaz L, Themistocleous AC, Yarnitsky D, Baron R. What is associated with painful polyneuropathy? A cross-sectional analysis of symptoms and signs in patients with painful and painless polyneuropathy. Pain. 2024 Dec 1;165(12):2888-2899. doi: 10.1097/j.pain.0000000000003310. Epub 2024 Jul 3.
- Study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Bennett, Prof. study director
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by University of Kiel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Pain measured by Pain severity (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04888455, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.