Minimally invasive lumbar treatment shows promising 6-month results for low back pain relief
The interim analysis of a 12-month study on lumbar interlaminar decompression with interspinous fixation for spinal stenosis has shown promising results.
At the 6-month mark, a significant percentage of patients demonstrated clinically meaningful and statistically significant improvement in pain, as measured by various assessment tools.
The study, a single-arm, multicenter, prospective, open-label trial, evaluated patient outcomes at 3- and 6-month intervals post-treatment. Clinical efficacy was primarily assessed using the Oswestry Disability Index (ODI), Visual Analog Scale (VAS) measuring back and leg pain during walking and standing, and Zurich Claudication Questionnaire (ZCQ). Secondary assessments included the Patient Global Impression of Change (PGIC) and Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1. Safety endpoints included adverse events and reoperations or revisions at the treated levels.
At 6-months, 76% of patients showed clinically meaningful and statistically significant improvement in pain, as defined by ZCQ. Similar improvements were observed in VAS scores for both back (62%-64%) and leg pain (64%), as well as in ODI (64%). Overall, 78% of patients reported a positive change in PGIC, indicating a subjective improvement in their overall condition.
The safety analysis noted 2 procedure-related adverse events, both of which fully resolved without the need for surgical intervention.
The interim analysis, conducted at 42% enrollment completion, underscores the sustained improvement in clinical efficacy and safety endpoints compared to the 3-month evaluations. This positive trend was observed across both interventional pain and neurosurgery specialties, emphasizing the potential for this minimally invasive treatment to provide durable symptom relief for patients suffering from low back pain.
Reference
Falowski SM, Raso LJ, Mangal V, et al. Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous Fusion Device: REFINE Study 6-Month Results. J Pain Res. 2023;16:4113-4126. doi: 10.2147/JPR.S427407. PMID: 38058981; PMCID: PMC10697144.
