CRF vs WCRF or PRF-DRG in CLBP of FJ Origin and RFA Failure of MBDR: Central Sensitization and Aberrant Nerve Sprouting
Unknown statusNot applicableNCT04542798
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The investigators will select two study groups from a population of patients with severe chronic low back pain (CLBP) of facet joint (FJ) origin already treated with conventional radiofrequency ablation (CRFA) of the medial branch of the dorsal ramus (MBDR) and that failed to obtain a 50% pain reduction measured through the numerical rate scale (NRS) for at least 3 months. Severe CLBP is considered a value of at least 7 by NRS pain assessment. The first group will be characterized by a nociceptive/mechanic type of back pain. The second group of study will be characterized by a neuropathic type of back pain. This difference will be established by a DN4 score of at least 4 points (Doleur Neurophatique 4). The patients in the group with nociceptive/mechanic back pain will be randomly assigned to conventional radiofrequency ablation or to water cooled radiofrequency (WCRF) of the MBDR. The patients in the group with neuropathic back pain will be randomly assigned CRFA of MBDR or to pulsed radiofrequency (PRF) of the dorsal root ganglia (DRG). The study will be carried on for an estimated time of 3 years. Primary outcomes will be: * at least 50% back pain reduction for at least 3 months evaluated through NRS, with a subcategorization of results that will consider a mean difference in effect (respect to the initial evaluation, with an initial NRS score of at least 7) of 1 point on NRS pain scale as small/modest, 2 points as moderate, more than 2 as large/substantial between the case/control study groups. * improvement of low back pain disability: 10 points increase on the Oswestry Low Back Pain Disability Questionnaire (ODI) have been proposed as minimal clinically important differences, between 10 and 20 as moderate, more than 20 as large/substantial clinical improvement at month 3 and 6. Secondary outcome will be evaluated by the 12-item short form survey SF12, accordingly with the clinical pre-interventional findings, analgesic intake at month 1-3-6 (if increased, unch…
Study details
- Official title
- Central Sensitization and Aberrant Nerve Sprouting Possible Explanations for RFA Failure of MBDR in CLBP of FJ Origin: CRF Versus WCRF or PRF-DRG Randomized Clinical Trial
- Conditions
- Interventions
- Device: Radiofrequency COSMAN
- Sponsor
- Hospital General Universitario de Valencia
- Start date
- 2020-10
- Primary completion
- 2021-05
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * patients with chronic lumbar back pain supposed to be of facet joint origin (low back pain irradiated to buttocks, legs, eventually feet in absence of exclusion criteria); * positivity to FJ provocative clinical tests, possible muscle spasm over the affected joints; * positivity to DN4 assessment in the NPPG + negative MBB and negative DN4 assessment + positive MMB in the NMPG; * efficacy of MBDR-RF treatment for at least one time reported in the personal clinical history, unresponsive to the last CRF or WCRF (only for the NPPG); * an MRI no more than 2 years; * basal NRS ≥ 7; * patients between 18y and 85y; * ASA (American Society of Anaesthesiologists scale) I-III; * absence of severe chronic disease associated, full mental capacity to sign the informed consent. This group is well aware that nowadays literature lack of confirmed clinical diagnostic criteria, like underlined in the last CPG-ASRAPM. Despite this issue, we decided to select our clinical criteria to better identify LBP of FJ origin following some of the indications mentioned in the Delphi survey of an expert panel (Wilde et al., 2007): * reproduction of similar or even worsening of basal pain during paravertebral finger pressure applied no more than 2-3 cm laterally to the midline (89% expert acceptance); * improvement of patient's pain during the flexion of the trunk while sitting (78% expert acceptance); * reduced range of motion or increased stiffness during local lateral passive movements (61% expert acceptance); * positive balance test with increased pain during extension - stress movements (after the flexion manoeuvre), or during lateral flexion (starting from 20 degree) and rotational axial movements (56% expert acceptance). * Another manoeuvre, taking into consideration the spinal columns' biomechanics, is realized asking the patients while standing with joined feet, to flex completely the trunk trying to touch with hands the top of his feet; this movement should not provoke patients' usual pain or worsen it; after that is invited to slowly return to a neutral position, stopping for 5 seconds in a 90-degree position between the trunk and the feet; during the extension movement to recover the initial position, the pain could worsen, or mimic the patients' usual pain, but it can't improve. We decided to include also patient that present with bilateral low back pain, despite this survey describe localized unilateral low back pain like one of possible clinical indic…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04542798