Comparison of Functional Improvement in patients of chronic low back pain with facet joint syndrome undergoing Cooled radiofrequency ablation vs Conventional Thermal Radiofrequency Ablation
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Effectiveness and safety and functional improvement by Oswestry Disability Index (ODI) of cooled radiofrequency ablation versus conventional radiofrequency ablation (cRFA) for the treatment of chronic low back pain associated with lumbar facet joint dysfunction.
Study Overview
Brief Summary
Lumbar facet dysfunction is a common cause of chronic low back pain, affecting millions of individuals worldwide. Facet joints are well known source of axial lower back pain, and the prevalence of facet joint pain varies from 20% to 44%. The clinical diagnosis of facet joint mediated pain is challenging due to inadequate sensitivity and specificity of clinical and radiological test. Therefore, medial branch blocks are used for diagnostic purposes in refractory cases, and may provide prognostic value before proceeding with radiofrequency ablation. The diagnostic blocks and radiofrequency treatments are validated in the facet joint mediated lumbar spinal pain. Majority of the studies in the literature are based on the traditional radiofrequency ablation (TRFA) procedure which was proved to be a safe. Effective, and leading pain therapy used to create sensory dysfunction in appropriate nerves via thermal energy. Water-cooled radiofrequency (CRFA) is a newer technique and may have some theoretical advantages over traditional radiofrequency (TRFA). This technology. Similar to TRFA, is also based on the heat neurotomy (60°C in CRFA versus 70-80°C in TRFA). Water circulation (at room temperature) through an isolated channel around the electrode tip creates a continuous “cooling†of the needle tip; consequently, the procedure typically results in a larger spherical- shape ablative area, with a diameter twice as long and extending distally from the tip of the electrode. Thus, CRFA may theoretically increase the success of radiofrequency ablation of the target nerves due to coverage of wider ablative area. As very few studies are present in literature comparing the two modalities Cooled RFA and Conventional RFA. In this prospective comparative non inferiority study, we aim to compare the efficacy, functional outcome, pain relief and complications, in patients undergoing Cooled RFA verses Conventional RFA.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Inclusion Criteria- a) Patient of chronic low back pain due to lumber facet syndrome diagnosed by controlled diagnostic ‘median branch block’.
- •b) Age 18-80 of either sex.
- •c) Refractory to conservative treatment including activity modification, home exercise, physical therapy, medication.
Exclusion Criteria
- •Exclusion Criteria- a) Patient who declined consent.
- •b) Patient having history of drug allergy.
- •c) Patient with coagulation abnormality or local site infection.
- •d) Pregnant patient and patient with pacemaker in situ.
- •e) Disc herniation, stenosis, myelopathy, lumbar facet.
Outcomes
Primary Outcomes
Effectiveness and safety and functional improvement by Oswestry Disability Index (ODI) of cooled radiofrequency ablation versus conventional radiofrequency ablation (cRFA) for the treatment of chronic low back pain associated with lumbar facet joint dysfunction.
Time Frame: Data will be collected at baseline, post intervention, I month, 3 months 6 months post.intervention Statistical analysis will be performed to compare outcomes
Secondary Outcomes
- Secondary: Visual analog scale (VAS) for pain intensity, multifidus muscle thickness measured by ultrasound, PGIC (Global Patient Impression of Change- Patient Satisfaction)
Investigators
DR Shivani Rastogi
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES, VIBHUTI KHAND,GOMTI NAGAR, LUCKNOW.