A Phase 2 interventional study of Dexamethasone and Normal Saline in Facet Joint Pain, Arthropathy and Sacroiliac Joint Dysfunction, sponsored by Siriraj Hospital. Enrolling by invitation at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Siriraj Hospital · Phase 2, Interventional, and Prevention
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.
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.
386 studies on the registry are indexed under Joint Diseases; 64 are open to participants now.
This study's planned enrollment of 126 is above the median of 102 across 251 interventional studies indexed under Joint Diseases.
Browse Joint Diseases studies →Siriraj Hospital is the lead sponsor of 95 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Dexamethasone · Drug: Bupivacaine
Normal saline administered locally as an equivalent volume comparator mixed with bupivacaine following radiofrequency neurotomy.
Drug: Normal Saline · Drug: Bupivacaine
Dexamethasone administered locally at approximately 1.5 mg/mL/level mixed with bupivacaine following radiofrequency neurotomy.
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
0.5% bupivacaine administered locally at each lesion site following radiofrequency neurotomy in both study groups.
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)
Time frame: 4 weeks post-procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 4 weeks post-procedure
Plan to share: 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.
Supporting information: Clinical study report
Time frame: Available starting 6 months after publication for a period of 3 years
Access criteria: Access will be provided to qualified researchers who provide a methodologically sound proposal upon request via email to the principal investigator.
Start is estimated for Oct 2026; primary completion for Jul 2028, 21 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Dexamethasone
Siriraj Hospital