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Enrolling by invitation

NCT Number: NCT07839195

Effect of Post-Radiofrequency Corticosteroid Injection on the Incidence of Post-Neurotomy Neuritis

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.

Enrolling by invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Siriraj pain clinic, Department of Anesthesiology, Faculty of Medicine Siriraj hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Dexamethasone

Drug

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.

normal saline

Drug

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

Primary outcomes

  1. The incidence of post-neurotomy neuritis (PNN) in patients undergoing radiofrequency neurotomy with and without post-RFN local corticosteroid injection

    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)

Secondary outcomes

  1. Mean Pain Score Assessed by the Numerical Rating Scale (NRS-11)

    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.

  2. Functional Disability Score Assessed by ODI or NDI

    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.

  3. Incidence of Procedural Complications and Adverse Events

    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.

  4. Total Duration of Post-Neurotomy Neuritis (PNN) Symptoms

    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?

Enrolling by invitation

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Collaborators

  • Siriraj Research & Development

Registry information

Official study title

Effect of Post-Radiofrequency Corticosteroid Injection on the Incidence of Post-Neurotomy Neuritis: A Randomized Controlled Trial

Acronym: PNN

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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