Cryoneurolysis versus radiofrequency ablation outcome on pain experience in chronic low back pain (COPE): a single-blinded randomised controlled trial.

OBJECTIVE: A comparison of cryoneurolysis or radio frequency (RF) with placebo in patients with facetogenic chronic low back pain (LBP) for patient global impression of change (PGIC), pain intensity, function and quality of life, with 1-year follow-up. DESIGN: Single-centre, single-blinded placebo-controlled randomised controlled trial. SETTING: Single-centre study. PARTICIPANTS: Inclusion from March 2020 to September 2022: consenting adults over 18 years of age, LBP>3 months, average Numeric Rating Scale LBP≥4 average last 14 days and a positive response to a diagnostic medial branch block (>50% pain reduction after 60 min). INTERVENTIONS: 120 patients were block randomised 1:1:1 to cryoneurolysis, RF or placebo of the medial branch nerves. Physical therapy was added after 4 weeks for all groups. MAIN OUTCOME MEASURES: Primary outcome was PGIC 4 weeks after the intervention. Secondary outcomes included pain intensity (Numeric Rating Scale, NRS), quality of life (Short Form 36, EQ-5D-5L), disability (Oswestry Disability Index), depression (Major Depression Inventory) and catastrophising (Pain Catastrophising Scale). Outcomes were measured at 4 weeks, 3, 6 and 12 months. RESULTS: There was no statistically significant difference in PGIC at 4 weeks between cryoneurolysis and placebo (risk ratio (RR) 2; 95% CI 0.75 to 5.33, p=0.17) and RF and placebo (RR 1.6; 95% CI 0.57 to 4.49, p=0.37), except PGIC for cryoneurolysis at 6-month follow-up (RR 5.1; 95% CI 1.20 to 22.03, p=0.03). No statistically significant differences were found in secondary follow-up endpoints. CONCLUSIONS: Denervation of the medial branch nerve by either cryoneurolysis or RF compared with placebo did not demonstrate significant improvement in PGIC, pain intensity, function and quality of life in patients with facetogenic chronic LBP at short-term or long-term follow-up. TRIAL REGISTRATION NUMBER: NCT04786145.

[Ankylosing spinal fractures may result in perforation of oesophagus].

Oesophageal lesions due to spinal fractures are very rare and easily overlooked. In this case report a woman was involved in a minor car accident, and she was primarily examined at the accident and emergency department with no signs of fractures. Ten days later, she was readmitted due to high infection counts and back pain. She had an unstable fracture of Th4 and a perforation of the oesophagus due to ankylosing fractures. The case emphasises the need to pay attention to a possible development of secondary oesophageal perforation in ankylosing spines and unstable fractures, and the need for a special attention when examinating this group of patients.

Addition of TLIF does not improve outcome over standard posterior instrumented fusion. 5-10 years long-term Follow-up: results from a RCT.

PURPOSE: The use of inter-body device in lumbar fusions has been difficult to validate, only few long-term RCT are available. METHODS: Between 2003 and 2005, 100 patients entered a RCT between transforaminal lumbar inter-body fusion (TLIF) or posterolateral instrumented lumbar fusion (PLF). The patients suffered from LBP due to segmental instability, disc degeneration, former disc herniation, spondylolisthesis Meyerding grade <2. Functional outcome parameters as Dallas pain questionnaire (DPQ), SF-36, low back pain questionnaire (LBRS), Oswestry disability index (ODI) were registered prospectively, and after 5-10 years. RESULTS: Follow-up reached 93 % of available, (94 %, 44 in the PLF's and 92 %, 44 in the TLIF group p = 0.76). Mean follow-up was 8.6 years (5-10 years). Mean age at follow-up was 59 years (34-76 years p = 0.19). Reoperation rate in a long-term perspective was equal among groups 14 %, each p = 0.24. Back pain was 3.8 (mean) (Scale 0-10), TLIF (3.65) PLF (3.97) p = 0.62, leg pain 2.68 (mean) (Scale 0-10) 2.90 (TLIF) and 2.48 (PLF) p = 0.34. No difference in functional outcome between groups p = 0.93. Overall, global satisfaction with the primary intervention at 8.6 year was 76 % (75 % TLIF and 77 % PLF) p = 0.85. CONCLUSION: In a long-term perspective, patients with TLIF's did not experience better outcome scores.