Prediction of Outcome of Interventional Pain Management

NCT02774694 | Not Yet Recruiting

• 1 other identifier: 15-072
• Study Type: observational
• Target: 350
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain; Neck Pain; Chronic Pain

Keywords

nociceptive flexion reflex; interventional pain management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• ROC-AUC for incidence of pain reduction>30% at 1 month

  1 month

• ROC-AUC for incidence of pain reduction>30% at 3 months

  3 months

• ROC-AUC for 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

Study Arms (1)

observational cohort

patients undergoing interventional pain management procedures

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

Interventions

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

measurement of the NFR threshold using the "Paintracker" device

Also known as: R3 reflex

observational cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Benno Rehberg-Klug: lead

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Low Back Pain; Neck Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Benno Rehberg-Klug, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benno Rehberg-Klug, MD

CONTACT

+41223723476; benno.rehberg-klug@hcuge.ch

Stanislas Mathivon

CONTACT

stanislas.mathivon@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Médecin adjoint agrégé

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: May 17, 2016
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 8, 2024

Record last verified: 2024-05