Last reviewed · How we verify
NCT05624307: RaFr
Selection of Chronic Low Back Pain Patients for Neurotomy Surgery Radiofrequency
trial in Pain;Back Low;Chronic in 160 participants. Status unknown.
15 November 2023
Quick facts
| Lead sponsor | FondationbHopale |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 160 |
| Start date | 21 November 2022 |
| Primary completion | 15 November 2023 |
| Estimated completion | 15 May 2024 |
| Sites | 1 location across France |
Conditions studied
- Pain;Back Low;Chronic — all drugs for Pain;Back Low;Chronic →
Sponsor
FondationbHopale
Who can join
Adults 18 to 65, any sex, with Pain;Back Low;Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Chronic low back pain is one of the leading causes of disability associated with significant health care costs. One possible management of chronic low back pain of facet origin is neurotomy-radiofrequency (NT-RF) intervention. Currently, to determine whether a patient is eligible for NT-RF, two positive block tests are required. Clinical examination with a homolateral extension-rotation-tilt maneuver of the spine (ERI maneuver) would have the potential to identify subjects with pain of facet origin. It could therefore be a simple and effective diagnostic tool in the evaluation of a patient with low back pain and help in the decision whether or not to perform a test block by local infiltration of the zygapophyseal joint prior to an NT-RF procedure. The purpose of this longitudinal, prospective, observational, single-center study is to evaluate the performance of the combined extension-rotation-lateral tilt maneuver (ERI maneuver) in predicting the response to neurotomy-radiofrequency intervention in patients with chronic low back pain. The included patients will answer 5 questionnaires, in addition to the usual clinical data: * Hospital Anxiety and Depression scale (HAD) questionnaire, * Quality of life questionnaire EQ-5D-5L, * Brief Pain Inventory - French version: Questionnaire Concis de la Douleur (QCD), * Functional Impotence Scale for Low Back Pain: The Quebec Back Pain Disability Scale * Clinical Global Impression of Change (CGI-C)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05624307
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pain;Back Low;Chronic
Currently open trials in the same condition.
- NCT06825390 — AuriculoTherapy NeuroImaging · NA · recruiting
- NCT05463367 — Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure · Phase 2 · active not recruiting
Other FondationbHopale trials
Trials by the same sponsor.
- NCT05653089 — Positioning in Wheelchair Bound Patients · NA · unknown
- NCT05420623 — Walking Strategies in Usual Locomotion of Lower Limb Amputees · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05624307 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by FondationbHopale
- Last refreshed: 12 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05624307.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing