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Lumber Facet Joint Pain(Lower Back Pain ) Relief by Cooled Radiofrequency or Thermal Radiofrequency DenervationNCT07309731

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

A study testing thermal radio frequency denervation and Cooled Radiofrequency denervation in people with Lumber Facet Joint Pain(Lower Back Pain ) Relief by Cooled Radiofrequency or Thermal Radiofrequency Denervation, run by Zagazig University at 2 sites in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 . Read more about this study

Who is it for?
Ages 30 to 70 years
What is being tested?
thermal radio frequency denervation and Cooled Radiofrequency denervation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesEgypt
Study dates
15 Jan 2026to 1 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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 .
Show all 10Show fewer
  • Rheumatic disorders.
  • Systemic infections, or local infections in the field of intervention .
  • Any uncontrolled medical or psychiatric condition .
  • Pregnancy, lactating women .

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt2 sites, 2 recruiting
  • Faculty of Medicine,Zagazig University

    Zagazig, Elsharqya, 44519

    Khadeja M El-Hossieny, MD, 01015706099 ext. 002, khadejaelhossieny@gmail.com

    Recruiting
  • Faculty of Medicine,Zagazig University

    Zagazig, Elsharqya, 44519

    MANAL M RASHAD, MD, 01005671564 ext. 002, mervatassy@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: 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 .

Read more

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.

Being tested
thermal radio frequency denervation, Cooled Radiofrequency denervation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • thermal radio frequency denervationDevice

    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

  • Cooled Radiofrequency denervationDevice

    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

Study groups in NCT07309731
Study groupRoleWhat they receive
thermal radio frequency denervation (T) groupActive comparatorThe 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
Receives: Device: thermal radio frequency denervation
Cooled Radiofrequency denervation (C) groupActive comparatorPatients 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
Receives: Device: Cooled Radiofrequency denervation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain intensity

    using a numerical rating scale (NRS) ranging from 0 to 10 (0: "no pain" to 10: "the worse pain")

    Measured: 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 .

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2025
  2. Study start15 Jan 2026 (estimated)
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07309731
Sponsor's protocol ID
1788/2-Nov-2025
Status last verified
Jan 2026
First submitted
15 Dec 2025
Last updated
6 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: planed after completion of the study and publication

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-2023-104568.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 37143095
  • 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.

    PubMed 32503359
  • 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.

    PubMed 30777903
  • 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.

    PubMed 25535620
  • 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.

    PubMed 30867144
  • 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.

    PubMed 32353665

Questions about this trial

What is this clinical trial studying?

A study testing thermal radio frequency denervation and Cooled Radiofrequency denervation in people with Lumber Facet Joint Pain(Lower Back Pain ) Relief by Cooled Radiofrequency or Thermal Radiofrequency Denervation, run by Zagazig University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact manal M rashad, MD (01005671564 ext. 002, mervatassy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 .). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07309731, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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