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

NCT07839195 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: 261/2569(IRB2)
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Facet Joint Pain; Arthropathy; Sacroiliac Joint Dysfunction; Post-neurotomy Neuritis; Chronic Pain

Keywords

radiofrequency ablation; radiofrequency neurotomy; Post-neurotomy neuritis; Medial Branch Block; Dexamethasone; Corticosteroids

Outcome Measures

Primary Outcomes (1)

• 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)

  4 weeks post-procedure

Secondary Outcomes (4)

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

  Baseline and 4 weeks post-procedure

• Functional Disability Score Assessed by ODI or NDI

  Baseline and 4 weeks post-procedure

• Incidence of Procedural Complications and Adverse Events

  Up to 4 weeks post-procedure

• Total Duration of Post-Neurotomy Neuritis (PNN) Symptoms

  Up to 4 weeks post-procedure

Study Arms (2)

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

Drug: Dexamethasone; Drug: Bupivacaine

Non-steroid group

PLACEBO COMPARATOR

Normal saline administered locally as an equivalent volume comparator mixed with bupivacaine following radiofrequency neurotomy.

Drug: Normal Saline; Drug: Bupivacaine

Interventions

Bupivacaine DRUG

0.5% bupivacaine administered locally at each lesion site following radiofrequency neurotomy in both study groups.

Non-steroid group; Steroid group

Dexamethasone DRUG

Dexamethasone administered locally at approximately 1.5 mg/mL/level mixed with bupivacaine following radiofrequency neurotomy.

Steroid group

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

Non-steroid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siriraj Hospital: lead
• Siriraj Research & Development: collaborator

Study Sites (1)

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

Bangkok, 10700, Thailand

Location

Related Publications (15)

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• Malaithong 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.

  PMID: 36938106 BACKGROUND

• Fitzpatrick 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.

  PMID: 35051159 BACKGROUND

• Shustorovich 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.

  PMID: 34793638 BACKGROUND

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  BACKGROUND

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  PMID: 130217 BACKGROUND

• Singh 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.

  PMID: 30700070 BACKGROUND

• Yiengprugsawan 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.

  PMID: 28103864 BACKGROUND

• WHO 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.

  PMID: 14679827 BACKGROUND

MeSH Terms

Conditions

Joint Diseases; Chronic Pain

Interventions

Dexamethasone; Saline Solution; Bupivacaine

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: 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

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 24, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• 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.

Locations

TH (1)