Prediction of Outcome of Interventional Pain Management

NCT ID: NCT02774694

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-09-30

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.

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.

Conditions

Low Back Pain; Neck Pain; Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

observational cohort

patients undergoing interventional pain management procedures

nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany)

Intervention Type: DEVICE

measurement of the NFR threshold using the "Paintracker" device

Interventions

nociceptive flexion reflex (NFR) threshold ("Paintracker", Dolosys GmbH, Berlin, Germany)

measurement of the NFR threshold using the "Paintracker" device

Intervention Type: DEVICE

Other Intervention Names

R3 reflex

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benno Rehberg-Klug

OTHER

Sponsor Role: lead

Responsible Party

Benno Rehberg-Klug

Médecin adjoint agrégé

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Benno Rehberg-Klug, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Central Contacts

Benno Rehberg-Klug, MD

Role: CONTACT

benno.rehberg-klug@hcuge.ch

+41223723476

Stanislas Mathivon

Role: CONTACT

stanislas.mathivon@hcuge.ch

Other Identifiers

15-072

Identifier Type: -

Identifier Source: org_study_id