The spine journal : official journal of the North American Spine Society
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Randomized Controlled Trial Multicenter Study
A prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study).
Balloon kyphoplasty (BKP) is a commonly performed vertebral augmentation procedure for painful osteoporotic vertebral compression fractures (OVCFs). ⋯ Study results demonstrated non-inferiority of the TIVAD to the predicate BKP with an excellent risk/benefit profile for results up to 12 months.
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Randomized Controlled Trial Multicenter Study
A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain.
Current literature suggests that degenerated or damaged vertebral endplates are a significant cause of chronic low back pain (LBP) that is not adequately addressed by standard care. Prior 2-year data from the treatment arm of a sham-controlled randomized controlled trial (RCT) showed maintenance of clinical improvements at 2 years following radiofrequency (RF) ablation of the basivertebral nerve (BVN). ⋯ Minimally invasive RF ablation of the BVN led to significant improvement of pain and function at 3-months in patients with chronic vertebrogenic related LBP.
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Randomized Controlled Trial Comparative Study
Supervised physical therapy vs. home exercise for patients with lumbar spinal stenosis: a randomized controlled trial.
Exercise has been reported to improve short-term outcomes for patients with LSS in terms of disability and back and leg pain. However, no studies have compared supervised exercise with unsupervised exercise or quantified physical activity using a pedometer to confirm compliance with a home exercise program. ⋯ Supervised PT for patients with LSS resulted in significant short-term improvements in symptom severity, physical function, walking distance, pain, and physical activity compared with unsupervised exercise.
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Randomized Controlled Trial
The NECK trial: Effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blinded randomized controlled trial.
Motion preserving anterior cervical disc arthroplasty (ACDA) in patients with cervical radiculopathy was introduced to prevent symptomatic adjacent disc degeneration as compared with anterior cervical discectomy and fusion (ACDF). Prior reports suggest that ACDF is not more effective than anterior cervical discectomy (ACD) alone for the treatment of cervical radiculopathy. ⋯ The hypothesis that ACDA would lead to superior clinical outcome in comparison to ACDF or ACD could not be confirmed during a 2-year follow-up time period. Single level ACD without implanting an intervertebral device may be a reasonable alternative to ACDF or ACDA.
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Randomized Controlled Trial
A Prospective Randomized Study to Analyze the Efficacy of Balanced Preemptive Analgesia in Spine Surgery.
Surgical procedures involving the spine are known to cause moderate to severe postoperative pain. Inadequate management of acute pain in the postoperative period results in higher morbidity, and consequently may lead to chronic pain caused by central sensitization. The role of pre-emptive analgesia (PA) and intraoperative analgesia in management of postoperative pain has gained precedence over recent years. Pathophysiology of postoperative pain in spine surgery is unique, as it is a combination of nociceptive, inflammatory, and neuronal stimuli. Blockage of all three stimuli in the perioperative period by pre-emptively administrating a combination of paracetamol (P), ketorolac (K), and pregabalin (PR) might help in adequate management and alleviation of acute postoperative pain. ⋯ Postoperative pain management in spine surgery is maximized if perioperative painful stimuli can be inhibited, which requires adequate blood levels of analgesic, anti-inflammatory, and neuropathic drugs intraoperatively. The employed strategy of preoperative administration of balanced analgesia with a combination of P, K, and PR, each having different mechanisms of action, resulted in lesser pain intensity, allowed better ambulation tolerance, improved functional outcomes and has also reduced the requirement of opioids and duration of hospital stay with no additional complications. Thus, this balanced analgesia administered preoperatively would address the complicated postsurgical pain.