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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumber Facet Joint Pain(Lower Back Pain ) Relief by Cooled Radiofrequency or Thermal Radiofrequency Denervation
• Intervention / Treatment: Device: thermal radio frequency denervation; Device: Cooled Radiofrequency denervation

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MANAL M RASHAD, MD; Phone Number: 002 01005671564; Email: mervatassy@yahoo.com

Study Locations

• Egypt
  • Elsharqya
    • Zagazig, Elsharqya, Egypt, 44519
      • Recruiting
      • Faculty of Medicine,Zagazig University
      • Contact: MANAL M RASHAD, MD; Phone Number: 002 01005671564; Email: mervatassy@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

  1. 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,
  2. Patients have two to three levels of bilateral facet arthropathy with normal motor power of lower extremities
  3. 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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: thermal radio frequency denervation (T) group; 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 (volt), the frequency 2 Hz for 120 s, three cycles with rotation of the needle each time. At the end of the radiofrequency(RF)procedure, after the probe is removed , 20 mg methylprednisolone acetate will be given through the RF needle for each level	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 RF needle for each level
Active Comparator: Cooled Radiofrequency denervation (C) group; 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 (cooled radio frequency ablation) 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.The RFA generator temperature set to 60°C (intralesional temperature >80°) for 150 seconds for each	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.The RFA (radio frequency ablation) generator temperature set to 60°C (intralesional temperature >80°) for 150 seconds for each

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity	using a numerical rating scale (NRS) ranging from 0 to 10 (0: "no pain" to 10: "the worse pain")	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 .

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: khadeja m elhossieny, MD, Zagazig University

Publications and helpful links

General Publications

• Shih CL, Shen PC, Lu CC, Liu ZM, Tien YC, Huang PJ, Chou SH. A comparison of efficacy among different radiofrequency ablation techniques for the treatment of lumbar facet joint and sacroiliac joint pain: A systematic review and meta-analysis. Clin Neurol Neurosurg. 2020 Aug;195:105854. doi: 10.1016/j.clineuro.2020.105854. Epub 2020 Apr 19.
• 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.
• Rubinstein SM, de Zoete A, van Middelkoop M, Assendelft WJJ, de Boer MR, van Tulder MW. Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials. BMJ. 2019 Mar 13;364:l689. doi: 10.1136/bmj.l689.
• McCormick ZL, Choi H, Reddy R, Syed RH, Bhave M, Kendall MC, Khan D, Nagpal G, Teramoto M, Walega DR. Randomized prospective trial of cooled versus traditional radiofrequency ablation of the medial branch nerves for the treatment of lumbar facet joint pain. Reg Anesth Pain Med. 2019 Mar;44(3):389-397. doi: 10.1136/rapm-2018-000035.
• Mukherjee K, Das A, Basunia SR, Dutta S, Mandal P, Mukherjee A. Evaluation of Magnesium as an adjuvant in Ropivacaine-induced supraclavicular brachial plexus block: A prospective, double-blinded randomized controlled study. J Res Pharm Pract. 2014 Oct;3(4):123-9. doi: 10.4103/2279-042X.145387.
• 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.
• Manchikanti L, Kaye AD, Soin A, Albers SL, Beall D, Latchaw R, Sanapati MR, Shah S, Atluri S, Abd-Elsayed A, Abdi S, Aydin S, Bakshi S, Boswell MV, Buenaventura R, Cabaret J, Calodney AK, Candido KD, Christo PJ, Cintron L, Diwan S, Gharibo C, Grider J, Gupta M, Haney B, Harned ME, Helm Ii S, Jameson J, Jha S, Kaye AM, Knezevic NN, Kosanovic R, Manchikanti MV, Navani A, Racz G, Pampati V, Pasupuleti R, Philip C, Rajput K, Sehgal N, Sudarshan G, Vanaparthy R, Wargo BW, Hirsch JA. Comprehensive Evidence-Based Guidelines for Facet Joint Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines Facet Joint Interventions 2020 Guidelines. Pain Physician. 2020 May;23(3S):S1-S127.
• 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-2023-104568.
• 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.
• 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. Erratum In: J Pain Res. 2019 Jun 12;12:1877. doi: 10.2147/JPR.S217726.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Estimated): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 1, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1788/2-Nov-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: planed after completion of the study and publication
• IPD Sharing Time Frame: planed after completion of the study and publication
• IPD Sharing Access Criteria: principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No