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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observational cohort | patients undergoing interventional pain management procedures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany) | Device | measurement of the NFR threshold using the "Paintracker" device |
|
| Measure | Description | Time Frame |
|---|---|---|
| ROC-AUC for incidence of pain reduction>30% at 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 | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| ROC-AUC for incidence of pain reduction>30% at 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 | 1 month |
| ROC-AUC for incidence of pain reduction>30% at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Included will be patients treated by the interventional pain management team of the department of anaesthesiology of the Geneva University Hospitals HUG
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| Name | Affiliation | Role |
|---|---|---|
| Benno Rehberg-Klug, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Genève | Geneva | 1205 | Switzerland |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D019547 | Neck Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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blood sample
|
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 months |
| ROC-AUC for incidence of pain reduction>30% at 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 | 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 | The presence or unexcused absence of the patient at each consultation visit is noted | 6 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |