CRF vs WCRF or PRF-DRG in CLBP of FJ Origin and RFA Failure of MBDR: Central Sensitization and Aberrant Nerve Sprouting

NCT04542798 | Unknown DMC FDA Device

• 1 other identifier: 34831
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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, unchanged, decreased, in dosages or number of pain killers' assumption). Groups sizes: will be calculated based on the disease's incidence and the outcome targets.

Conditions

Low Back Pain, Recurrent; Neuropathic Pain; Facet Joint Pain; Central Sensitisation; Aberrant Neuronal Branching; Nociceptive Pain; Mechanical Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• PNRS change >= 50%

  At least 50% back pain reduction for at least 3 months valuated through NRS, with a subcategorization of results that will consider a mean difference in effect (respect to the initial evaluation, with a 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.

  3 and 6 months

• ODI change > 10 points

  Improvement of low back pain disability: 10 points reduction 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.

  3 and 6 months

Secondary Outcomes (2)

• SF12 change >= 20 points

  3 and 6 months

• Pain killer drugs intake

  6 mounths

Study Arms (4)

NPPG (neuropatic pain group) PRF

EXPERIMENTAL

Pulsed radiofrequency neuromodulation of dorsal root ganglia

Device: Radiofrequency COSMAN

NPPG (neuropatic pain group) CRF

ACTIVE COMPARATOR

Conventional radiofrequency ablation of the medial branch of the dorsal nerve

Device: Radiofrequency COSMAN

NMPG (nociceptive/mechanic pain group) WCRF

EXPERIMENTAL

Water cooled radiofrequency of the medial branch of the dorsal nerve

Device: Radiofrequency COSMAN

NMPG (nociceptive/mechanic pain group) CRF

ACTIVE COMPARATOR

Conventional radiofrequency ablation of the medial branch of the dorsal nerve

Device: Radiofrequency COSMAN

Interventions

Radiofrequency COSMAN DEVICE

Radiofrequency ablation and neuromodulation

Also known as: Pulsed Radiofrequency, Water Cooled Radiofrequency, Conventional Radiofrequency

NMPG (nociceptive/mechanic pain group) CRF; NMPG (nociceptive/mechanic pain group) WCRF; NPPG (neuropatic pain group) CRF; NPPG (neuropatic pain group) PRF

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General Universitario de Valencia: lead

Study Sites (1)

General Universitary Hospital of Valencia

Valencia, Spain

Location

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MeSH Terms

Conditions

Low Back Pain; Neuralgia; Nociceptive Pain

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Officials

• Giuseppe Luca Formicola, MD

  Fellow at the General Universitary Hospital of Valencia, Department of Pain Medicine, Resident in Anesthesia and Intensive Care of San Raffaele Hospital, Milan, Italy

  PRINCIPAL INVESTIGATOR

• Gustavo Fabregat Cid, MD, PhD

  MD, PhD at Multidisciplinary Pain Management Unit, Anesthesia, Critical Care, and Pain Management Department, General University Hospital, Valencia, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Luca Formicola, MD

CONTACT

+393397261936; formicola.giuseppelu@hsr.it

Gustavo Fabregat Cid, MD, PhD

CONTACT

+34696043220; gfabregat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will not be aware of the technique performed and the data will be collected by a physician unaware of the technique applied. Clinical report form will not contain any identifying data of the patient except for the identification number generated at the time of randomization. The follow up visit will be done identifying the patient by its identification number. After the technique performance, to ensure the blind, the patient will follow the planned out of study postprocedural visit, and a different physician, blind to the technique and to the patient identity, will make the follow up planned at 1, 3 and 6 months. The investigator will open the blind only if it is essential for the patients' management in efficacy and security, and if during the check visit there are clinical reason to do so (mostly severe complications related to the techniques applied and necessity for invasive intervention). The monitor can open the blind for intermediate statistical analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 9, 2020
• Study Start: October 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: March 1, 2024
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

ES (1)