Neuropathic PainNCT02666456
The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain
An observational study of Neuropathic Pain and Polyneuropathy, run by University of Kiel.
Trial summary
Cross-sectional and longitudinal analysis of the somatosensory phenotype, assessed by quantitative sensory testing (QST) and Information obtained by questionnaires to detect risk factors for neuropathic pain development and chronification in painless and chronic pain patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Polyneuropathy, Peripheral Nerve Injury
- What is being tested?
- QST, Questionnaires
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Mar 2019
- 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: Painless patients and patients with chronic peripheral neuropathic pain.
Who may be able to join
- Chronic peripheral neuropathic pain or
- Painless Patient with risk to develop neuropathic pain (post-surgery, chemotherapy-induced)
Who cannot join
- Minors
Trial locations and contacts
No sites are listed yet.
About this study
Official title: DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain
Cross-sectional and longitudinal analysis of the somatosensory phenotype, assessed by quantitative sensory testing (QST) and Information obtained by questionnaires to detect risk factors for neuropathic pain development and chronification in painless and chronic pain patients.
- Conditions
- Neuropathic Pain, Polyneuropathy, Peripheral Nerve Injury
- Being tested
- QST, Questionnaires
- Medical subject headings
- Neuralgia, Polyneuropathies, Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QST, QuestionnairesOther
Assessment of sensory phenotype by QST and questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Cross-sectional cohort | Patients with chronic peripheral neuropathic pain Receives: Other: QST, Questionnaires | |
| Longitudinal cohort | Painless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, Operation) Receives: Other: QST, Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatosensory phenotype detected by quantitative sensory testing (QST)
The somatosensory phenotype will be assessed by quantitative sensory testing (QST) once at baseline
Measured: Single assessment at baseline (cross-sectional study). Report of complete cohort data at study completion
Change of neuropathic pain: Development and chronification of neuropathic pain detected by DN4 questionnaire
Assessment with DN4 pain questionnaire
Measured: Assessment of change of neuropathic pain from baseline and 6 months after study enrollment (longitudinal study). Report of complete cohort data at study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andras Binder, University of Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666456
- Sponsor's protocol ID
- DOLORisk WP4
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain
- ClinicalTrials.gov ID
- NCT02666456
- Acronym / sponsor ID
- DOLORisk WP4
- Conditions
- Neuropathic Pain, Polyneuropathy, Peripheral Nerve Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of KielUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2019 (estimated)
- First posted
- 28 Jan 2016 (estimated)
- 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.
Cross-sectional and longitudinal analysis of the somatosensory phenotype, assessed by quantitative sensory testing (QST) and Information obtained by questionnaires to detect risk factors for neuropathic pain development and chronification in painless and chronic pain patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-sectional cohort | – | Other: QST, QuestionnairesPatients with chronic peripheral neuropathic pain |
| Longitudinal cohort | – | Other: QST, QuestionnairesPainless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, Operation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Painless patients and patients with chronic peripheral neuropathic pain.
Key inclusion criteria (2 listed)
- Chronic peripheral neuropathic pain or
- Painless Patient with risk to develop neuropathic pain (post-surgery, chemotherapy-induced)
Key exclusion criteria (1 listed)
- Minors
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 |
|---|---|---|
| QST, QuestionnairesAssessment of sensory phenotype by QST and questionnaires | Other | Cross-sectional cohort, Longitudinal cohort |
Primary outcome
Somatosensory phenotype detected by quantitative sensory testing (QST)
Time frame: Single assessment at baseline (cross-sectional study). Report of complete cohort data at study completion
The somatosensory phenotype will be assessed by quantitative sensory testing (QST) once at baseline
Change of neuropathic pain: Development and chronification of neuropathic pain detected by DN4 questionnaire
Time frame: Assessment of change of neuropathic pain from baseline and 6 months after study enrollment (longitudinal study). Report of complete cohort data at study completion.
Assessment with DN4 pain questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Funding sourceLink provided by the sponsor.
- WEbsiteLink 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Polyneuropathy, run by University of Kiel.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Binder, MD (+49 431 597 ext. 8822, andreas.binder@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatosensory phenotype detected by quantitative sensory testing (QST) (time frame: Single assessment at baseline (cross-sectional study). Report of complete cohort data at study completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2016.