Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial.

BACKGROUND: Impaired neuromuscular control and degeneration of the multifidus muscle have been linked to the development of refractory chronic low back pain (CLBP). An implantable restorative-neurostimulator system can override the underlying multifidus inhibition by eliciting episodic, isolated contractions. The ReActiv8-B randomized, active-sham-controlled trial provided effectiveness and safety evidence for this system, and all participants received therapeutic stimulation from four months onward. OBJECTIVE: This study aimed to evaluate the two-year effectiveness of this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. MATERIALS AND METHODS: Open-label follow-up of 204 participants implanted with a restorative neurostimulation system (ReActiv8, Mainstay Medical, Dublin, Ireland) was performed. Pain intensity (visual analog scale [VAS]), disability (Oswestry disability index [ODI]), quality-of-life (EQ-5D-5L), and opioid intake were assessed at baseline, six months, one year, and two years after activation. RESULTS: At two years (n = 156), the proportion of participants with ≥50% CLBP relief was 71%, and 65% reported CLBP resolution (VAS ≤ 2.5 cm); 61% had a reduction in ODI of ≥20 points, 76% had improvements of ≥50% in VAS and/or ≥20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 87% of participants had continued device use during the second year for a median of 43% of the maximum duration, and 60% (34 of 57) had voluntarily discontinued (39%) or reduced (21%) opioid intake. CONCLUSIONS: At two years, 76% of participants experienced substantial, clinically meaningful improvements in pain, disability, or both. These results provide evidence of long-term effectiveness and durability of restorative neurostimulation in patients with disabling CLBP, secondary to multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The study is registered on clinicaltrials.gov with identifier NCT02577354.

Degenerative Spondylolisthesis.

Degenerative spondylolisthesis (DS) is one of the more commonly encountered spine conditions. The diagnosis of DS has changed little in the last 30 years. However, there has been an evolution in the treatment of this disease entity. There have been several landmark papers that helped govern our treatment. These helped serve as the basis for the treatment arms of the Spine Patient Outcomes Research Trial (SPORT), which offers the highest quality evidence to date. Although few would argue that the fusion of the diseased segment appears to offer the best and most durable results, treatment of this disease is best tailored to the individual. Fusion may offer the best results in the young active patient, but the same results may never become evident in the medically infirm patient. Laminectomy or unilateral laminoforaminotomy still plays a role in disease treatment. This review will focus on the diagnosis and the treatment of DS as well as discuss the author's preferred treatment of this disease.

Juvenile xanthogranuloma in an adult lumbar spine: a case report.

STUDY DESIGN: Case report. OBJECTIVE: To report a very rare case of juvenile xanthogranuloma (JXG) of the spine in an adult. SUMMARY OF BACKGROUND DATA: JXG is very rare in the spine, with only five prior reports in infants and children. To the best of our knowledge, this tumor has never been reported in an adult spine. METHODS: The patient is a 47-year-old woman who presented with bowel and bladder incontinence. Magnetic resonance imaging showed a very large lesion arising from the L2 vertebral body, with massive extension into the retroperitoneum with extensive intradural involvement. She had decreased rectal tone, had 4/5 strength in the right hip flexor, and had diminished sensation in her anterior right thigh and perineal region. She was otherwise neurologically intact. After preoperative embolization, a decompressive laminectomy was performed and the tumor was resected through a posterolateral transpedicular approach, followed by stabilization. Because of extensive involvement of retroperitoneum, complete resection was not possible. RESULTS: After pathologic evaluation of the specimen, a diagnosis of JXG was made. Patient underwent postoperative radiation therapy, and her neurologic examination improved significantly over the next several months. CONCLUSIONS: To the best of our knowledge, this is the first reported case of JXG in an adult spine. Although complete resection of the tumor was not possible, decompression of the dural sac followed by postoperative radiation led to an excellent clinical outcome.