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Prediction of Outcome of Interventional Pain Management (POINTPM)

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ClinicalTrials.gov Identifier: NCT02774694
Recruitment Status : Not yet recruiting
First Posted : May 17, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Benno Rehberg-Klug, University Hospital, Geneva

Brief Summary:
Interventional pain management for back and neck pain is widely used, but the indications and relative merits of these techniques rest subject to discussion. This study aims to identify prognostic criteria for patients who might specifically benefit from interventional pain management. Specifically, the nociceptive reflex threshold will be investigated, which is a measure of central sensibilisation and thus a potentially important prognostic factor.

Condition or disease Intervention/treatment
Low Back Pain Neck Pain Chronic Pain Device: nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany)

Detailed Description:

Interventional pain management is resource-intensive and carries non-negligible risks. Not all patients profit equally from such procedures. For those who do not benefit, the risk of potential complications is futile, and the resources are wasted. Therefore, a possibility to distinguish responding patients from non-responders would be important.

Central pain sensitization has been related to poor outcome, and electrical pain and reflex thresholds are a good measure of pain hypersensitivity at least in chronic low back pain. Especially the nociceptive flexion reflex (NFR) threshold has been identified to correlate well with central pain hypersensibility. Successful interventional pain treatment has been shown to reverse central hypersensibility as measured by the NFR threshold.

NFR threshold, in contrast to pain threshold, seems to be a measure independent of psychological factors. Thus the NFR threshold could give information independent of psychological factors in order to predict poor outcome of interventional pain management procedures.

The study will be a prospective observational trial of diagnostic accuracy.


Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of the Nociceptive Flexion Reflex Threshold to Predict Outcome After Interventional Pain Management Procedures in Patients With Chronic Back and Neck Pain. A Study of Diagnostic Accuracy
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
observational cohort
patients undergoing interventional pain management procedures
Device: nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany)
measurement of the NFR threshold using the "Paintracker" device
Other Name: R3 reflex




Primary Outcome Measures :
  1. ROC-AUC for incidence of pain reduction>30% at 1 week [ Time Frame: 1 week ]

    Primary study outcome is the diagnostic accuracy of the NFR threshold, measured as area under the "receiver operating characteristic ROC" curve, for the following main pain management outcome:

    "pain reduction of 30% one week after the interventional procedure



Secondary Outcome Measures :
  1. ROC-AUC for incidence of pain reduction>30% at 1 month [ Time Frame: 1 month ]
    Area Under the curve (AUC) of the receiver-operating characteristic (ROC) of the relation between NFR reflex threshold and the incidence of pain reduction>30% at 1 month

  2. ROC-AUC for incidence of pain reduction>30% at 3 months [ Time Frame: 3 months ]
    Area Under the curve (AUC) of the receiver-operating characteristic (ROC) of the relation between NFR reflex threshold and the incidence of pain reduction>30% at 3 months

  3. ROC-AUC for incidence of pain reduction>30% at 6 months [ Time Frame: 6 months ]
    Area Under the curve (AUC) of the receiver-operating characteristic (ROC) of the relation between NFR reflex threshold and the incidence of pain reduction>30% at 6 months

  4. ROC-AUC for physical functioning at 1 week [ Time Frame: 1 week ]
  5. ROC-AUC for emotional functioning at 1 week [ Time Frame: 1 week ]
  6. ROC-AUC for patient rating of improvement and satisfaction at 1 week [ Time Frame: 1 week ]
  7. adverse events of interventional pain management [ Time Frame: 1 week ]
  8. patient disposition at 1 week, 1,3, and 6 months [ Time Frame: 6 months ]
    The presence or unexcused absence of the patient at each consultation visit is noted


Biospecimen Retention:   Samples With DNA
blood sample


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Included will be patients treated by the interventional pain management team of the department of anaesthesiology of the Geneva University Hospitals HUG
Criteria

Inclusion Criteria:

  • patients with chronic low back or neck pain (duration >3 months)
  • scheduled for the following interventions: epidural injection, facet block, medial branch block, facet radiofrequency denervation, spinal cord stimulator implantation

Exclusion Criteria:

  • inability to understand the patient information or the study questionnaires
  • patients <18 years old
  • patients with implanted pacemakers or defibrillators

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774694


Contacts
Contact: Benno Rehberg-Klug, MD +41223723476 benno.rehberg-klug@hcuge.ch
Contact: Stanislas Mathivon stanislas.mathivon@hcuge.ch

Sponsors and Collaborators
Benno Rehberg-Klug
Investigators
Principal Investigator: Benno Rehberg-Klug, MD Hôpitaux Universitaires de Genève

Responsible Party: Benno Rehberg-Klug, Médecin adjoint agrégé, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02774694     History of Changes
Other Study ID Numbers: 15-072
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Benno Rehberg-Klug, University Hospital, Geneva:
nociceptive flexion reflex
interventional pain management

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Chronic Pain
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms