Facet Joint Pain; Low Back Pain
Conditions
Keywords
Back pain, Facet joint pain, Sidekick cannula, Chronic back pain
Brief summary
Lumbar facet joint-mediated chronic low back pain is a common cause of disability. Radiofrequency ablation (RFA) of the lumbar medial branches is an established interventional pain treatment. Different cannula designs may influence lesion geometry and clinical outcomes. This prospective randomized study aims to compare the clinical outcomes of conventional cannulas and sidekick cannulas used during lumbar medial branch radiofrequency ablation. Patients with chronic lumbar facet joint pain who meet inclusion criteria will be randomly assigned to receive RFA using either a conventional cannula or a sidekick cannula technique. The primary objective is to evaluate pain reduction following the procedure. Secondary outcomes include functional improvement and duration of pain relief during follow-up.
Detailed description
Chronic low back pain related to lumbar facet joints is a frequent clinical problem in pain medicine. Lumbar medial branch radiofrequency ablation (RFA) is widely used for the treatment of facet-mediated pain when diagnostic blocks are positive. Cannula design and electrode orientation may affect lesion size and nerve capture during RFA. The sidekick cannula has been developed to optimize lesion orientation relative to the target nerve and potentially improve procedural efficiency and clinical outcomes compared with conventional cannulas. This prospective randomized clinical study is conducted to compare the effectiveness of conventional cannulas and sidekick cannulas in lumbar medial branch radiofrequency ablation. Eligible adult patients with chronic lumbar facet joint-mediated pain confirmed by diagnostic medial branch blocks will be enrolled. Participants will be randomly allocated to one of two groups: RFA performed with a conventional cannula or RFA performed with a sidekick cannula. Pain intensity, functional outcomes, and treatment response will be evaluated during follow-up visits. The results of this study aim to determine whether cannula design influences procedural success and clinical outcomes in lumbar medial branch radiofrequency ablation.
Interventions
PROCEDURELumbar Medial Branch Radiofrequency Ablation
Lumbar medial branch radiofrequency ablation performed for chronic lumbar facet-mediated pain. The procedure is performed under fluoroscopic guidance .
Triamcinolone acetonide administered after ablation as part of the post-procedural injection mixture.
DRUGbupivacain 0.5% 2ml
Bupivacaine 0.5% administered after ablation as part of the post-procedural injection mixture.
DEVICEconventional radiofrequency cannul
standard straight radiofrequency cannula used during lumbar medial branch radiofrequency ablation
DEVICEsidekick radiofrecueny cannula
sidekick radiofrequeny cannula designed to preduce a larger lesion during lumbaar brach medial branch radiofrequeny ablation
Sponsors
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This is a single-blind randomized study. Participants and outcome assessors are blinded to the cannula type used during lumbar medial branch radiofrequency ablation. The physician performing the procedure is aware of the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥18 years * Chronic lumbar facet-mediated low back pain lasting more than 3 months * Failure of conservative treatment including physical therapy and medical management * Positive diagnostic medial branch block * Patients scheduled for lumbar medial branch radiofrequency ablation
Exclusion criteria
* Previous lumbar radiofrequency ablation at the same level * Coagulopathy or anticoagulant therapy that cannot be discontinued * Local infection at the procedure site * Severe spinal deformity or instability * Pregnancy * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity (Numeric Rating Scale) | Baseline to 6 months | Change in pain intensity measured by Numeric Rating Scale (NRS) Pain intensity will be measured using the Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional improvement | 6 months | Functional status will be assessed using the Modified Oswestry Disability Index (MODI), a validated questionnaire evaluating disability related to low back pain. The MODI consists of 10 items with a total score ranging from 0 to 100, where higher scores indicate greater disability and worse functional status. Changes in MODI scores will be evaluated during follow-up after lumbar medial branch radiofrequency ablation using conventional or sidekick cannulas. |
Countries
Turkey (Türkiye)
Outcome results
None listed