POINTPM: Prediction of Outcome of Interventional Pain Management
Study Details
Study Description
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 | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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 Names:
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Outcome Measures
Primary Outcome Measures
- ROC-AUC for incidence of pain reduction>30% at 1 week [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
- ROC-AUC for incidence of pain reduction>30% at 1 month [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
- ROC-AUC for incidence of pain reduction>30% at 3 months [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
- ROC-AUC for incidence of pain reduction>30% at 6 months [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
- ROC-AUC for physical functioning at 1 week [1 week]
- ROC-AUC for emotional functioning at 1 week [1 week]
- ROC-AUC for patient rating of improvement and satisfaction at 1 week [1 week]
- adverse events of interventional pain management [1 week]
- patient disposition at 1 week, 1,3, and 6 months [6 months]
The presence or unexcused absence of the patient at each consultation visit is noted
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients with chronic low back or neck pain (duration >3 months)
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scheduled for the following interventions: epidural injection, facet block, medial branch block, facet radiofrequency denervation, spinal cord stimulator implantation
Exclusion Criteria:
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inability to understand the patient information or the study questionnaires
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patients <18 years old
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patients with implanted pacemakers or defibrillators
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Benno Rehberg-Klug
Investigators
- Principal Investigator: Benno Rehberg-Klug, MD, Hôpitaux Universitaires de Genève
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15-072