Trial Outcomes & Findings for A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves Versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome (NCT NCT03614793)

Enrollment started in October of 2018. Out of 1128 participants, 1089 did not meet eligibility criteria and 35 weren't interested. 39 were randomized. 6 withdrew from the FJI group before treatment, 5 due to insurance denial of FJI (started during the study recruitment period) and 1 who lost interest in the study. Of the 13 remaining patients in the FJI group, 1 individual was lost to follow-up after receiving FJI treatment. Consequently, a total of 32 patients were analyzed in this study.

During screening, some participants were discontinued before randomization. The most common reasons were: Insurance denied payment of second medial branch block, Participant had a Cobb angle greater than 10, Participant had concurrent radiculopathy, Negative medial branch block, Did not meet eligibility criteria

Race and Ethnicity were not collected from any participant.

This is a scale from 0 to 10, with 0 being no back pain at all and 10 being the worst back pain imaginable The primary outcome for this study was the proportion of participants within each group (C-RFA and FJI) who experienced a greater than or equal to 50% reduction in NPRS score at 3 months. Participants were asked to rate their pain over the past 7 days on a scale from 0 to 10.

ODI Percentage 0% to 20%: minimal disability: The patient can cope with most living activities. Usually, no treatment is indicated apart from advice on lifting sitting and exercise. 21%-40%: moderate disability: The patient has more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%: These patients are either bed-bound or exaggerating their symptoms. This secondary outcome measured how many participants had an equal to or greater than 30% decrease in their ODI score.

The PGIC questionnaire allows participants to give their opinion on how well the treatment worked for them. Participants are asked to rate the status of their lower back pain after treatment: Very much worse, Much worse, Minimally worse, No change, Minimally improved, Much improved and Very much improved. The variable for this outcome was how many participants reported equal to or greater than a 6, which would be "Much improved" or "Very much improved."

This outcome was measured at 6 months from the NPRS scale, 0 being no pain to 10 being the worst pain imaginable, to see how many participants had an equal to or greater than a 2-point reduction in their pain compared to baseline.

PGIC survey-based assessment of subjective improvement in overall symptoms. This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status.

Report immediate, short-term, and long-term adverse effects, using a standardized survey that includes a comprehensive query of known adverse events associated with systemic steroid effects