CRF vs WCRF or PRF-DRG in CLBP of FJ Origin and RFA Failure of MBDR: Central Sensitization and Aberrant Nerve Sprouting
Low Back Pain, Recurrent, Neuropathic Pain, Facet Joint Pain
About this trial
This is an interventional treatment trial for Low Back Pain, Recurrent focused on measuring PULSED RADIOFREQUENCY, WATER-COOLED RADIOFREQUENCY, CONVENTIONAL RADIOFREQUENCY, CHRONIC LOW BACK PAIN, CENTRAL SENSITIZATION, ABERRANT NERVE SPROUTING, FACET JOINT, NEUROPATHIC PAIN, NOCICEPTIVE/MECHANICAL LOW BACK PAIN, RADIOFREQUENCY OF MEDIAL BRANCH OF DORSAL NERVE FAILURE
Eligibility Criteria
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 indicator of lumbar facet joint pain (80% expert agreement); this decision is based on our clinical experience.
Exclusion Criteria:
- positive MBB with positive DN4;
- negative MMB with negative DN4;
- positive EMG for neuropathic pain of radicular origin (89% expert acceptance),
- diagnostic imaging of significant radicular compression (based on the radiologist judgement);
- late diagnosis of other causes of LBP, cancer related pain, neoplastic patients, patients with life expectation inferior to 1 year;
- BMI > 35;
- patients insurance or work absence related interests
- patient refusal
- Back's depression inventory II (BDI-II) > 20,
- previous lumbar spinal, pelvic and knee surgery, or significant stenosis of the spinal canal that can interfere with diagnosis;
- patient with systemic infection, pregnant or breastfeeding woman, untreatable coagulative problems;
- clinical doubt by the enrolling physician that can interfere with the evaluation's efficacy of the procedures under investigation (like hip pain, cluneal nerve's entrapment pain, trochanteritis, myofascial pain, etc.);
- any contraindication to neuraxial injection.
- Social risk factors that could influence the adherence to the study protocol will be taken into consideration and valuated accordingly.
Sites / Locations
- General Universitary Hospital of Valencia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
NPPG (neuropatic pain group) PRF
NPPG (neuropatic pain group) CRF
NMPG (nociceptive/mechanic pain group) WCRF
NMPG (nociceptive/mechanic pain group) CRF
Pulsed radiofrequency neuromodulation of dorsal root ganglia
Conventional radiofrequency ablation of the medial branch of the dorsal nerve
Water cooled radiofrequency of the medial branch of the dorsal nerve
Conventional radiofrequency ablation of the medial branch of the dorsal nerve