Facet Joint PainPhase 2PNNNCT07839195
Effect of Post-Radiofrequency Corticosteroid Injection on the Incidence of Post-Neurotomy Neuritis
A Phase 2 study testing Dexamethasone, Normal Saline and Bupivacaine in people with Facet Joint Pain and Arthropathy, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the incidence of post-neurotomy neuritis (PNN) in adult patients undergoing radiofrequency neurotomy (RFN) for spine facet and sacroiliac joint pain, comparing those who receive a local corticosteroid injection after the procedure with those who do not. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Facet Joint Pain, Arthropathy, Sacroiliac Joint Dysfunction
- What is being tested?
- Dexamethasone, Normal Saline and Bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2026to Oct 2028
- Phase
- Phase 2
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient who aged equal and over 18 years old
- Patient who scheduled for cervical, thoracic, and lumbar medial branch RFN and sacral lateral branch RFN
- Patient who communicated effectively, demonstrated good understanding of questions and provided appropriate responses
Who cannot join
- Contraindications to corticosteroids: Patients with a known allergy or hypersensitivity to dexamethasone or other glucocorticoids
- Contraindications to local anesthetics: Patients with a history of severe allergic reactions to amide-type local anesthetics (e.g., bupivacaine)
- Active Infection: Presence of localized infection at the planned injection site or systemic infection (sepsis) that may contraindicate the procedure
- Coagulopathy: Patients with uncorrected bleeding disorders or those unable to safely discontinue anticoagulant/antiplatelet medications according to standard procedural guidelines
- Pregnancy or Lactation: Pregnant or breastfeeding women, due to potential risks associated with radiation (fluoroscopy) and medication exposure
- Recent Corticosteroid Exposure: Patients who have received systemic or local corticosteroid injections at the target site within the past 3 months, which may interfere with the study outcomes
- Unstable Neurological Conditions: Patients with progressive neurological deficits or acute radiculopathy that requires urgent surgical intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Siriraj pain clinic, Department of Anesthesiology, Faculty of Medicine Siriraj hospital
Bangkok, 10700
About this study
Official title: Effect of Post-Radiofrequency Corticosteroid Injection on the Incidence of Post-Neurotomy Neuritis: A Randomized Controlled Trial
The purpose of this study is to compare the incidence of post-neurotomy neuritis (PNN) in adult patients undergoing radiofrequency neurotomy (RFN) for spine facet and sacroiliac joint pain, comparing those who receive a local corticosteroid injection after the procedure with those who do not. Participants are randomly assigned to receive either local anesthetic with dexamethasone or local anesthetic alone at the treatment sites. Pain scores, functional disability, and adverse events are evaluated before the procedure and at 4 weeks follow-up.
Read the detailed description
Spine-related pain, including cervicalgia, dorsalgia, and lumbalgia, represents a major clinical challenge. Low back pain affects a substantial proportion of the global population and is associated with reduced physical activity and functional limitations in activities of daily living. Facet joint arthropathy is a frequent cause of axial spine pain resulting from repetitive biomechanical stress, local inflammation, and synovitis. Radiofrequency neurotomy (RFN) of the medial branch nerves is an established, minimally invasive interventional modality for managing recalcitrant facet pain.
Although RFN is generally safe, post-neurotomy neuritis (PNN)-a neuropathic condition characterized by burning, dysesthesia, or sunburn-like pain along the treated distribution-remains an important post-procedural complication. Reported incidence rates vary widely, and symptoms may persist for weeks to months. To mitigate PNN, clinicians frequently administer local corticosteroids through the cannula immediately following thermal lesioning; however, existing literature presents conflicting evidence regarding its efficacy, with reported outcomes ranging from significant risk reduction to no apparent protective effect.
This randomized, double-blind, parallel-group controlled trial evaluates whether local corticosteroid administration following RFN reduces the incidence of PNN in adult patients undergoing radiofrequency denervation for cervical, thoracic, lumbar facet, or sacroiliac joint pain at Siriraj Hospital.
Following confirmation of eligibility and written informed consent, enrolled participants are randomized into two parallel groups. All procedures are performed under fluoroscopic guidance by boarded-certified pain specialists using an 18-gauge, 100-mm RF cannula with a 10-mm active tip. Proper positioning is verified via multiplanar fluoroscopy, accompanied by motor and sensory electrical stimulation testing. Lesioning is conducted with a Boston G4 RF Generator, delivering two cycles per target site at 80°C for 3 minutes per cycle.
Following neurotomy, injectates are prepared by an unblinded independent physician to maintain allocation concealment :
- Steroid Group: Receives a local injection of dexamethasone mixed with 0.5% bupivacaine (approximately 1.5 mg/mL/level of dexamethasone).
- Control Group: Receives an equivalent volume of 0.5% bupivacaine alone without corticosteroid.
Both the proceduralist and the participant remain blinded throughout the study. Post-procedural evaluations are conducted at 4 weeks post-intervention via in-person visits or telemedicine to evaluate neuropathic symptoms, pain intensity, functional disability status, and procedural adverse events. An interim analysis is planned when 50% of the target enrollment completes follow-up to monitor efficacy and patient safety.
- Conditions
- Facet Joint Pain, Arthropathy, Sacroiliac Joint Dysfunction, Post-neurotomy Neuritis, Chronic Pain
- Being tested
- Dexamethasone, Normal Saline, Bupivacaine
- Keywords
- radiofrequency ablation, radiofrequency neurotomy, Post-neurotomy neuritis, Medial Branch Block, Dexamethasone, Corticosteroids
- Medical subject headings
- Joint Diseases, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone administered locally at approximately 1.5 mg/mL/level mixed with bupivacaine following radiofrequency neurotomy.
Normal SalineDrug
In the non-steroid group, same 0.5% bupivacaine volume was diluted with normal saline in same volume to dexamethasone of steroid group for injectate volume corresponding to the number of lesion sites after complete radiofrequency neurotomy
BupivacaineDrug
0.5% bupivacaine administered locally at each lesion site following radiofrequency neurotomy in both study groups.
| Study group | Role | What they receive |
|---|---|---|
| Steroid group | Experimental | In the steroid group, dexamethasone was mixed with 0.5% bupivacaine to achieve dexamethasone approximated 1.5 mg/ml/level for injectate volume corresponding to the number of lesion sites after complete radiofrequency neurotomy Receives: Drug: Dexamethasone; Drug: Bupivacaine |
| Non-steroid group | Placebo comparator | Normal saline administered locally as an equivalent volume comparator mixed with bupivacaine following radiofrequency neurotomy. Receives: Drug: Normal Saline; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of post-neurotomy neuritis (PNN) in patients undergoing radiofrequency neurotomy with and without post-RFN local corticosteroid injection
The incidence of post-neurotomy neuritis (PNN) in patients undergoing radiofrequency neurotomy (RFN) at cervical, thoracic, lumbar facet and sacroiliac joint with and without post-RFN local corticosteroid injection (Post-neurotomy neuritis ; PNN is new-onset neuropathic-type pain which is tingling, numbness, burning, shooting, sunburn-like or confused signals from the degenerating nerve lasting ≥ 48 hours and occurring within 2 weeks after RFA)
Measured: 4 weeks post-procedure
Secondary outcomes (4)
Mean Pain Score Assessed by the Numerical Rating Scale (NRS-11)
Pain intensity is assessed using the Numerical Rating Scale (NRS-11), an 11-point scale where 0 represents "no pain" and 10 represents "worst imaginable pain". Higher scores indicate greater pain severity.
Measured: Baseline and 4 weeks post-procedure
Functional Disability Score Assessed by ODI or NDI
Functional disability is evaluated using the Oswestry Disability Index (ODI) for low back pain or the Neck Disability Index (NDI) for neck pain. Both tools range from 0% to 100%, with higher percentage scores indicating greater functional disability.
Measured: Baseline and 4 weeks post-procedure
Incidence of Procedural Complications and Adverse Events
The number and proportion of participants experiencing intervention-related adverse events, procedural complications, or unexpected side effects.
Measured: Up to 4 weeks post-procedure
Total Duration of Post-Neurotomy Neuritis (PNN) Symptoms
The total duration of reported post-neurotomy neuritis symptoms (such as tingling, numbness, burning, or shooting pain) recorded in days among participants who develop PNN.
Measured: Up to 4 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Facet Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This double-blind, randomized controlled trial approved by Mahidol University IRB enrolled 126 adults (63/group) undergoing radiofrequency neurotomy (RFN) for cervical, thoracic, lumbar facet, or sacroiliac joint pain at Siriraj Hospital. Patients were randomized into control (no steroid) or treatment groups (post-RFN dexamethasone + 0.5% bupivacaine). Under fluoroscopic guidance, 18-gauge 100-mm RF cannulas (10-mm active tip) delivered two 3-minute cycles at 80°C per site via a Boston G4 Generator following sensory/motor testing. Injectates (dexamethasone \~1.5 mg/mL/level or equal-volume bupivacaine alone) were prepared by an independent physician for allocation concealment. Both injectors and patients were blinded. Key outcomes included post-neurotomy neuritis (PNN) incidence (burning, numbness, or shooting pain) and NRS-11, ODI, and NDI scores evaluated at baseline and 4 weeks post-procedure (onsite/telemedicine). Staff underwent SOP training and delegation logs to ensure data inte
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Siriraj Research & Development
- Responsible party
- Principal investigator, Kanuengthip Chuensurat, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839195
- Sponsor's protocol ID
- 261/2569(IRB2)
- Acronym
- PNN
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data including demographic characteristics, primary outcome (PNN incidence), and secondary outcomes (NRS-11, ODI, NDI) will be shared upon reasonable request.
Publications
Benzon HT, Raja SN, Fishman SM, Liu SS, Cohen SP, editors. Essentials of Pain Medicine. 4th ed. Philadelphia: Elsevier Health Sciences; 2018.
Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.
PubMed 1834753Moisa, H. A., Nica, D. A., Popescu, E. C., Mohan, A. G., Iacob, G., & Ciurea, A. V. Current trends in Failed Back Surgery Syndrome: A brief literature review, management guide and the Romanian perspective. Medicina Moderna. 2021; 28(1).
Govind J, King W, Bailey B, Bogduk N. Radiofrequency neurotomy for the treatment of third occipital headache. J Neurol Neurosurg Psychiatry. 2003 Jan;74(1):88-93. doi: 10.1136/jnnp.74.1.88.
PubMed 12486273Malaithong W, Munjupong S. Combined Continuous Radiofrequency Ablation and Pulsed Neuromodulation to Treat Cervical Facet Joint Pain and Alleviate Postcervical Radiofrequency Side Effects. Anesth Pain Med. 2022 Dec 14;12(6):e129747. doi: 10.5812/aapm-129747. eCollection 2022 Dec.
PubMed 36938106Fitzpatrick B, Hilton K, Suer M, Poliak-Tunis M, Hetzel S. The Impact of Local Corticosteroid Administration on the Incidence of Post-Neurotomy Neuritis: A Prospective Investigation. Pain Physician. 2022 Jan;25(1):E121-E126.
PubMed 35051159Shustorovich A, AlFarra T, Arel AT, Singh JR, Roemmich RT, Chhatre A. Dexamethasone Effectively Reduces the Incidence of Post-neurotomy Neuropathic Pain: A Randomized Controlled Pilot Study. Pain Physician. 2021 Dec;24(8):517-524.
PubMed 34793638Cohen SP, Dossey AM, Kurihara C, et al. Incidence and characterization of neuritis after radiofrequency denervation of the medial branches for facet arthropathy. Pain Medicine. 2010;11(6):849-858.
Kornick C, Kramarich SS, Lamer TJ, Todd Sitzman B. Complications of lumbar facet radiofrequency denervation. Spine (Phila Pa 1976). 2004 Jun 15;29(12):1352-4. doi: 10.1097/01.brs.0000128263.67291.a0.
PubMed 15187637Stolzenberg D, Gordin V, Vorobeychik Y. Incidence of neuropathic pain after cooled radiofrequency ablation of sacral lateral branch nerves. Pain Med. 2014 Nov;15(11):1857-60. doi: 10.1111/pme.12553. Epub 2014 Sep 15.
PubMed 25220749Shealy CN. Percutaneous radiofrequency denervation of spinal facets. Treatment for chronic back pain and sciatica. J Neurosurg. 1975 Oct;43(4):448-51. doi: 10.3171/jns.1975.43.4.0448.
PubMed 125787Shealy CN. Facet denervation in the management of back and sciatic pain. Clin Orthop Relat Res. 1976 Mar-Apr;(115):157-64.
PubMed 130217Singh JR, Miccio VF Jr, Modi DJ, Sein MT. The Impact of Local Steroid Administration on the Incidence of Neuritis following Lumbar Facet Radiofrequency Neurotomy. Pain Physician. 2019 Jan;22(1):69-74.
PubMed 30700070Yiengprugsawan V, Hoy D, Buchbinder R, Bain C, Seubsman SA, Sleigh AC. Low back pain and limitations of daily living in Asia: longitudinal findings in the Thai cohort study. BMC Musculoskelet Disord. 2017 Jan 19;18(1):19. doi: 10.1186/s12891-016-1380-5.
PubMed 28103864WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New Millennium. The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ Tech Rep Ser. 2003;919:i-x, 1-218, back cover.
PubMed 14679827