Transforaminal Epidural Steroid Injection With Pulsed Radiofrequency for Chronic Lumbosacral Radicular Pain Management
Unknown statusPhase 4NCT02930057
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study is to examine the potential changes in levels of pain, quality of life (QoL) and activities of daily living (ADL) observed when transforaminal epidural steroid injection is administered in conjunction with pulsed radiofrequency treatment of the lumbar dorsal root ganglion during the initial 3 months follow-up period. Safety (monitoring side effects) of the treatment is determined. The study hypothesis is that the application of transforaminal epidural steroid injection (TFESI) in conjunction with pulsed radiofrequency treatment (PRF) treatment of the lumbar dorsal root ganglion would increase the treatment response of PRF and thereby provide a measurable difference in the pain scores, quality of life and activities of daily living for the patients suffering from chronic lumbosacral radicular pain.
Study details
- Official title
- Transforaminal Epidural Steroid Injection in Conjunction With Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for the Management of Chronic Lumbosacral Radicular Pain: a Randomized, Double-blind Trial
- Conditions
- Radicular
- Neuropathic, Lumbar, Lumbosacral
- Low Back Pain
- Back Pain With Radiation
- Interventions
- Drug: Celestone
- Procedure: pulsed radiofrequency treatment
- Drug: Control
- Sponsor
- Sheba Medical Center
- Start date
- 2016-10
- Primary completion
- 2017-10
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * men and women * age ≥18 years old, * pain intensity≥4 out of 10 on the numerical rating scale (NRS), * chronic lumbosacral radicular pain lasting ≥12 weeks, * dominant leg pain with less intense back pain, * the previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications. * segmental pain of a radicular nature originating from the lumbar segments and with a shooting or lancinating quality corresponding to a dermatome suggestive of the involved nerve root. * availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features. Exclusion Criteria: * patient refusal to participate in the study, * age \<18 years, * pregnant or nursing * pain \<4-points on NRS, * acute pain of onset lasting\<12 weeks, * progressive motor weakness in the affected leg, * allergies to local anesthetics, contrast dyes or steroids * significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging * presence of cancer accounting for back pain * patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment * steroid injection within the previous 12 weeks, * systemic infection, * injection site infection, * unstable medical or psychiatric condition
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02930057