Prediction of Outcome of Interventional Pain Management

Chronic Pain Clinical Trial

— POINTPM  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02774694
• Other study ID #: 15-072
• Status: Not yet recruiting
• Start date: January 2026
• Est. completion date: September 2027

Study information

• Verified date: May 2024
• Source: University Hospital, Geneva
• Contact: Benno Rehberg-Klug, MD
• Phone: +41223723476
• Email: benno.rehberg-klug[@]hcuge.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Low Back Pain
• Neck Pain

Intervention

Device:
• nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany)
measurement of the NFR threshold using the "Paintracker" device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Benno Rehberg-Klug

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	ROC-AUC for incidence of pain reduction>30% at 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 months
Secondary	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
Secondary	ROC-AUC for physical functioning at 1 week		1 week
Secondary	ROC-AUC for emotional functioning at 1 week		1 week
Secondary	ROC-AUC for patient rating of improvement and satisfaction at 1 week		1 week
Secondary	adverse events of interventional pain management		1 week
Secondary	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