Neuropathic PainNCT03109860
Can the Perception of a Treatment Influence Pain Processing - an Examination of Psychological and Neurobiological Mechanisms
An observational study of Neuropathic Pain, run by University of Aarhus.
Trial summary
The study investigates the effect of an open (in full view of the patient) vs hidden treatment (without the patient's knowledge). 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?
- Open-hidden
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2015to 1 Feb 2017
- 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: Patients with chronic neuropathic pain after thoracic surgery.
Who may be able to join
- Neuropathic pain > 3 on a 0-10 NRS.
Who cannot join
- Psychiatric or competing neurological disorders.
- Known allergies to any medications, including local anesthetics.
About this study
The study investigates the effect of an open (in full view of the patient) vs hidden treatment (without the patient's knowledge).
- Conditions
- Neuropathic Pain
- Being tested
- Open-hidden
- Keywords
- Chronic neuropathic pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-hiddenBehavioural
Administration of a treatment openly (in full view of the patient) vs hidden (without the patient's knowledge).
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical visual analogue scale
Neuropathic pain assessed on mechanical visual analogue scale
Measured: 10 minutes after treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start17 Apr 2015
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
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.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Augustinus Foundation, Denmark., The (Danish) Foundation for Neurological Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109860
- Sponsor's protocol ID
- Ina
- Status last verified
- Apr 2017
- First submitted
- 5 Apr 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Perception of a Treatment Influence Pain Processing - an Examination of Psychological and Neurobiological Mechanisms
- ClinicalTrials.gov ID
- NCT03109860
- Acronym / sponsor ID
- Ina
- Conditions
- Neuropathic Pain
- Keywords
- Chronic neuropathic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Augustinus Foundation, Denmark., The (Danish) Foundation for Neurological Research
- Study start
- 17 Apr 2015 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 12 Apr 2017 (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.
The study investigates the effect of an open (in full view of the patient) vs hidden treatment (without the patient's knowledge).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic neuropathic pain after thoracic surgery.
Key inclusion criteria (1 listed)
- Neuropathic pain > 3 on a 0-10 NRS.
Key exclusion criteria (2 listed)
- Psychiatric or competing neurological disorders.
- Known allergies to any medications, including local anesthetics.
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 |
|---|---|---|
| Open-hiddenAdministration of a treatment openly (in full view of the patient) vs hidden (without the patient's knowledge). | Behavioural | – |
Primary outcome
Mechanical visual analogue scale
Time frame: 10 minutes after treatment administration
Neuropathic pain assessed on mechanical visual analogue scale
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 14 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Neuropathic Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by University of Aarhus.
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 2 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 14 Nov 2017. 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?
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?
Mechanical visual analogue scale (time frame: 10 minutes after treatment administration). 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 14 Nov 2017.