drugset / Trial / NCT07839195
Effect of Post-Radiofrequency Corticosteroid Injection on the Incidence of Post-Neurotomy Neuritis
Phase 2
Enrolling by invitation
126 enrolled
Siriraj Hospital
Siriraj Research & Development · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2026-10
- Primary completion
- 2028-07
- Completion
- 2028-10
Publications
- Background Benzon HT, Raja SN, Fishman SM, Liu SS, Cohen SP, editors. Essentials of Pain Medicine. 4th ed. Philadelphia: Elsevier Health Sciences; 2018.
- Background Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.
- Background Moisa, 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).
- Background 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.
- Background 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.
- 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.
- 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.
- Background Cohen 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.
- Background 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.
- Background Stolzenberg 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.
- Background Shealy 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.
- Background Shealy CN. Facet denervation in the management of back and sciatic pain. Clin Orthop Relat Res. 1976 Mar-Apr;(115):157-64.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 1.5 mg/ml | Other |
| Background | Bupivacaine | Other / unclassified | 0.5 % | Other |