Impact OF Cooled Versus Thermal Radiofrequency Denervation In Management Of Chronic Lumber Facet Joint Pain

Official title

Impact OF Cooled Versus Thermal Radiofrequency Denervation In Management Of Chronic Lumber Facet Joint Pain.Prospective Study.

Overview

Chronic lumber facet joint pain is defined according to international association of study of pain (IASP)as multifactorial phenomenon of pain that persist more than 3 months after an injury and /or beyond the usual course of an acute lumber facet pain or a reasonable time for a comparable injury to heal . lumber facet joint degeneration (LRFJ) is the 1st source of chronic low back pain with an incidence of 15% t o 45 % among patients with low back pain . the spinal facet joint has an abundant nerve supply ; therefore, pain can be caused by arthritic change, degenerative change, inflammation, and injury . Degeneration of all LFJs (lumbar facet joints) was diagnosed using magnetic resonance image (MRI) , the most sensitive and diagnostic tool. Thus, hypertrophy, degeneration, and the accumulation of fluid within the joints are signs of LFJ degeneration it was found in all treated LFJs . facet joint pain management can be achieved using medical therapy or facet joint therapeutic interventions, ultrasound guided injection,or fluoroscopically guided facet joint injection (FJI) , medial branch block (MBB) , or radiofrequency ablation . Radiofrequency is a minimally invasive procedure and is operated under light intravenous sedation or local anesthesia when necessary. Radiofrequency energy is delivered to the target nerves through an insulated needle , and this energy heats and denatures the nerve for the purpose of pain relief . The radiofrequency techniques include, thermal, and cooled radiofrequency . thermal radiofrequency (TRFA) uses more energy and higher temperature compared with cooled radiofrequency , cooled radiofrequency ablation (CRFA) is a newer technique, and may have some theoretical advantages over traditional radiofrequency whereas , cooled radiofrequency adopts internally probes to increase lesion size , and it can increase the chance of complete denervation . based on heat neurotomy (60°C (celsius) vs. 80°C in TRFA) with the resulting ablative area twice as long and extending distally from the tip of the electrode.

Interventions

• Device thermal radio frequency denervation
  The medial branch of the dorsal spinal ramus is the main target .The fluoroscopy will be then placed at slightly oblique view . An 22-gauge insulated RF needle with 1 cm active tip will be used .the parameters of Radiofrequency Denervation treatment are : the tip temperature being at 80 °C, 45V, the frequency 2 Hz for 120 s, three cycles with rotation of the needle each time. At the end of the RF procedure, after the probe is removed , 20 mg methylprednisolone acetate will be given through the R
• Device Cooled Radiofrequency denervation
  Patients will positioned prone with a C-arm fluoroscopy. 22-gauge spinal needles were placed in the appropriate location as lumbar medial branch blocks in Spinal Intervention Society Guidelines . 17-gauge 4 mm active tipped CRFA electrodes were used for the procedure . The CRFA electrodes were also placed in the appropriate location similar to described as lumbar medial branch blocks procedure, instead of traditional placement of electrodes described as in Spinal Intervention Society Guidelines.

Primary outcome measures

• Change in pain intensity [Time frame: NRS will be detected and recorded immediately 2 hours post intervention and then at 1 week , 1 month , 3 months, and 6 months after intervention .]

Eligibility criteria

Inclusion criteria

• Patient's acceptance .
• Both sexes (male and female).
• Age between 30 and 70 years .
• Physical status; ASA I , II. (American society of anesthesiologist)
• BMI; 22-30 Kg/m2.
• Presence of

• Chronic Lumbar Facet Joint Pain (numerical rating scale (NRS) ≥ 6) lasting for 3 months or more without any response to noninvasive conservative treatment methods like NSAIDs and gabapentin therapy for pain control, or physiotherapy,
• Patients have two to three levels of bilateral facet arthropathy with normal motor power of lower extremities
• Local paraspinal tenderness with increased pain on hyperextension, rotation, or lateral bending of the lower lumbar spine.
• More than or equal to 50% temporary pain relief following an ultrasound guided diagnostic medial branch block with local anesthetic corticosteroid injection.

Exclusion criteria

• Those with spondylolisthesis or disc herniation or internal disc disruption (IDD).
• Previous spinal surgery at the level to be treated , Spinal canal stenosis or spinal instability.
• Patient with previous radiofrequency ablation.
• Patients having radicular pain, neurogenic claudication, or neurological deficits.
• Coagulopathy, bleeding disorders .
• Allergy to medications or contrast to be used .
• Rheumatic disorders.
• Systemic infections, or local infections in the field of intervention .
• Any uncontrolled medical or psychiatric condition .
• Pregnancy, lactating women .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Egypt · 2 centers

• Faculty of Medicine,Zagazig University — Zagazig
• Faculty of Medicine,Zagazig University — Zagazig

Publications

• Cohen SP, Kapural L, Kohan L, Li S, Hurley RW, Vallejo R, Eshraghi Y, Dinakar P, Durbhakula S, Beall DP, Desai MJ, Reece D, Christiansen S, Chang MH, Carinci AJ, DePalma M. Cooled radiofrequency ablation versus standard medical management for chronic sacroiliac joint pain: a multicenter, randomized comparative effectiveness study. Reg Anesth Pain Med. 2024 Mar 4;49(3):184-191. doi: 10.1136/rapm-20 PMID 37407279
• Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16. PMID 18487245
• Candan B, Gungor S. Cooled-radiofrequency neurotomy for the treatment of chronic lumbar facet (zygapophyseal) joint pain: A retrospective study. Medicine (Baltimore). 2021 Dec 30;100(52):e28459. doi: 10.1097/MD.0000000000028459. PMID 34967387
• Coluzzi F, Polati E, Freo U, Grilli M. Tapentadol: an effective option for the treatment of back pain. J Pain Res. 2019 May 16;12:1521-1528. doi: 10.2147/JPR.S190176. eCollection 2019. PMID 31190963
• Davidson M, Keating J. Oswestry Disability Questionnaire (ODQ). Aust J Physiother. 2005;51(4):270. doi: 10.1016/s0004-9514(05)70016-7. No abstract available. PMID 16358452
• Dunlevy C, MacLellan GA, O'Malley E, Blake C, Breen C, Gaynor K, Wallace N, Yoder R, Casey D, Mehegan J, Fullen BM, O'Shea D. Does changing weight change pain? Retrospective data analysis from a national multidisciplinary weight management service. Eur J Pain. 2019 Sep;23(8):1403-1415. doi: 10.1002/ejp.1397. Epub 2019 May 21. PMID 30963658
• Kwak DG, Kwak SG, Lee AY, Chang MC. Outcome of intra-articular lumbar facet joint corticosteroid injection according to the severity of facet joint arthritis. Exp Ther Med. 2019 Nov;18(5):4132-4136. doi: 10.3892/etm.2019.8031. Epub 2019 Sep 20. PMID 31616521
• Li SJ, Zhang SL, Feng D. A comparison of pulsed radiofrequency and radiofrequency denervation for lumbar facet joint pain. J Orthop Surg Res. 2023 May 5;18(1):331. doi: 10.1186/s13018-023-03814-5. PMID 37143095

Identifiers

NCT: NCT07309731 · 1788/2-Nov-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗