Prophylactic Radiotherapy Of MInimally Symptomatic Spinal Disease (PROMISSeD): study protocol for a randomized controlled trial

Background: Early palliative/pre-emptive intervention improves clinical outcomes and quality of life for patients with metastatic cancer. A previous signal-seeking randomized controlled trial (RCT) demonstrated that early upfront radiotherapy to asymptomatic or minimally symptomatic high-risk osseous metastases led to reduction in skeletal-related events (SREs), a benefit driven primarily by subgroup of high-risk spine metastasis. The current RCT aims to determine whether early palliative/pre-emptive radiotherapy in patients with high-risk, asymptomatic or minimally symptomatic spine metastases will lead to fewer SREs within 1 year. Methods: This is a single-center, parallel-arm, in-progress RCT in adults (≥ 18 years) with ECOG performance status 0-2 and asymptomatic or minimally symptomatic (not requiring opioids) high-risk spine metastases from histologically confirmed solid tumor malignancies with \u3e 5 sites of metastatic disease on cross-sectional imaging. High-risk spine metastases are defined by the following: (a) bulkiest disease sites ≥ 2 cm; (b) junctional disease (occiput to C2, C7-T1, T12-L2, L5-S1); (c) posterior element involvement; or (d) vertebral body compression deformity \u3e 50%. Patients are randomized 1:1 to receive either standard-of-care systemic therapy (arm 1) or upfront, early radiotherapy to ≤ 5 high-risk spine lesions plus standard-of-care systemic therapy (arm 2), in the form of 20-30 Gy of radiation in 2-10 fractions. The primary endpoint is SRE, a composite outcome including spinal fracture, spinal cord compression, need for palliative radiotherapy, interventional procedures, or spinal surgery. Secondary endpoints include (1) surrogates of health care cost, including the number and duration of SRE-related hospitalizations; (2) overall survival; (3) pain-free survival; and (4) quality of life. Study instruments will be captured pre-treatment, at baseline, during treatment, and at 1, 3, 6, 12, and 24 months post-treatment. The trial aims to accrue 74 patients over 2 years to achieve \u3e 80% power in detecting difference using two-sample proportion test with alpha \u3c 0.05. Discussion: The results of this RCT will demonstrate the value, if any, of early radiotherapy for high-risk spine metastases. The trial has received IRB approval, funding, and prospective registration (NCT05534321) and has been open to accrual since August 19, 2022. If positive, the trial will expand the scope and utility of spine radiotherapy

Neuromodulation Techniques in Chronic Refractory Coccydynia: A Narrative Review

Refractory coccydynia is a condition characterized by severe coccygeal pain and poses a challenging management dilemma for clinicians. Advancements in neuromodulation (NM) technology have provided benefits to people experiencing chronic pain that is resistant to standard treatments. This review aims to summarize the spectrum of current NM techniques employed in the treatment of refractory coccydynia along with their effectiveness. A review of studies in the scientific literature from 2012 to 2023 was conducted, revealing a limited number of case reports. Although the available evidence at this time suggests significant pain relief with the utilization of NM techniques, the limited scope and nature of the studies reviewed emphasize the need for large-scale, rigorous, high-level research in this domain in order to establish a comprehensive understanding of the role of NM and its effectiveness in the management of intractable coccydyni

Management of Postoperative Discitis with Debridement and Novel Technique of Local Antibiotic Instillation: Functional Outcomes from a Resource-Limited Setting

Background: Patients in low- and middle-income countries (LMICs) have substantial treatment abandonment and non-adherence with outpatient oral medications. This work sought to investigate outcomes of postoperative discitis treated with debridement and a novel technique focused on reducing outpatient antibiotic requirement in an LMIC setting. Methods: This study, conducted and reported following STROBE guidelines, reviewed outcomes of all patients with postoperative discitis who had been debrided by 1 neurosurgeon in a resource-limited setting during 2008-2020. Patients had undergone single-level L4-L5 or L5-S1 discectomy elsewhere, later developing magnetic resonance imaging-confirmed discitis. After non-response or deterioration following intravenous antibiotics, patients underwent early debridement, followed by in-patient antibiotic instillation into disc space for 2 weeks via drain. Study outcomes were modified Kirkaldy-Willis Grade, Japan Orthopaedic Association (JOA) score, and visual analog scale (VAS) score, all assessed at 1 year. Results: Twelve patients were included, 10 male and 2 female, with median age of 46 (IQR 3.5) years. Debridement was done after median 82.5 (IQR 35) days and took median time of 105 (IQR 17.5) minutes. VAS scores (mean ± SD) decreased from 9.25 ± 0.75 preoperatively to 0.67 ± 0.89 1 year postoperatively (mean difference 8.58, 95% CI 8.01-9.15, P \u3c 0.001). JOA scores (mean ± SD) improved from 4.5 ± 2.94 to 26.42 ± 1.31 1 year postoperatively (mean difference 21.92, 95% CI 20.57-23.26, P \u3c 0.001). Kirkaldy-Willis grade was excellent in 6 (50%) patients, good in 5 (41.7%), and fair in 1 (8.3%). Patients became ambulatory within 2 weeks, with no major complications during 4.15 (IQR 3.45) years of median follow-up. Conclusions: In LMICs, patients with medically refractory postoperative discitis potentially have good outcomes after debridement plus 2-week local antibiotic instillation