Siriraj pain clinic, Department of Anesthesiology, Faculty of Medicine Siriraj hospital
Bangkok, 10700, Thailand
NCT Number: NCT07839195
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Bangkok, 10700, Thailand
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 :
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Post-radiofrequency neurotomy (RFN) local injection consisting of dexamethasone mixed with 0.5% bupivacaine (approximately 1.5 mg/mL/level of dexamethasone). A total volume of 1 mL of the prepared solution is administered at each lesion site via the RF cannula.
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
Time frame: 4 weeks post-procedure
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)
Time frame: Baseline and 4 weeks post-procedure
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.
Time frame: Baseline and 4 weeks post-procedure
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.
Time frame: Up to 4 weeks post-procedure
The number and proportion of participants experiencing intervention-related adverse events, procedural complications, or unexpected side effects.
Time frame: Up to 4 weeks post-procedure
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.
Interested in participating?
Request InfoSiriraj Hospital
Other
Effect of Post-Radiofrequency Corticosteroid Injection on the Incidence of Post-Neurotomy Neuritis: A Randomized Controlled Trial
Acronym: PNN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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