Articles: radiculopathy.
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Multicenter Study Clinical Trial
Composite Treatment Response from a Prospective, Multi-Center Study (US-nPower) Evaluating a Miniature Spinal Cord Stimulator for the Management of Chronic, Intractable Pain.
Measures of therapeutic efficacy in pain studies have historically focused on pain scores, such as the Visual Analog Scale (VAS) or the Numeric Rating Scale. However, pain scores capture a univariate measure of a multivariate condition present in patients with chronic pain, where the pain condition can affect activities of daily living, sleep, quality of life, and mood. Hence, examining composite endpoints, which incorporate outcomes from multiple facets of pain, may allow investigators to better assess improvements in chronic pain patients with various new treatments. ⋯ In the face of improving spinal cord stimulation pain outcomes, composite PROs are likely to become more common in evaluating therapeutic response. Responder rates, defined by the MCID, may help to establish composite endpoints. Since MCID was achieved across a variety of endpoints indicates that treatment with the Nalu Neurostimulation System provided a robust treatment response.
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Randomized Controlled Trial Multicenter Study
Cost-effectiveness of posterior versus anterior surgery for cervical radiculopathy: results from a multicentre randomised non-inferiority trial (FACET).
For cervical nerve root compression, anterior cervical discectomy with fusion (anterior surgery) or posterior foraminotomy (posterior surgery) are safe and effective options. Posterior surgery might have a more beneficial economic profile compared to anterior surgery. The purpose of this study was to analyse if posterior surgery is cost-effective compared to anterior surgery. ⋯ In patients with cervical radiculopathy, arm pain and QALYs were similar between posterior and anterior surgery. Posterior surgery was associated with lower costs and is therefore likely to be cost-effective compared with anterior surgery.
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Randomized Controlled Trial Multicenter Study
The Safety and Effectiveness of Orthobiologic Injections for Discogenic Chronic Low Back Pain: A Multicenter Prospective, Crossover, Randomized Controlled Trial with 12 Months Follow-up.
Chronic low back pain is one of the most common causes of disability, affecting more than 600 million people worldwide with major social and economic costs. Current treatment options include conservative, surgical, and minimally invasive interventional treatment approaches. Novel therapeutic treatment options continue to develop, targeting the biological cascades involved in the degenerative processes to prevent invasive spinal surgical procedures. Both intradiscal platelet-rich plasma (PRP) and bone marrow concentrate (BMC) applications have been introduced as promising regenerative treatment procedures. ⋯ This is the only human lumbar disc study that evaluates both PRP and BMC in the same study and compares it to placebo. PRP and BMC were found to be superior to placebo in improving pain and function; however, larger randomized clinical trials are needed to answer further questions on the comparative effectiveness of various biologics as well as to identify outcome differences specific to disc pathology.
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Multicenter Study Observational Study
Results From a Prospective, Clinical Study (US-nPower) Evaluating a Miniature Spinal Cord Stimulator for the Management of Chronic, Intractable Pain.
Chronic, intractable, neuropathic pain is readily treatable with spinal cord stimulation (SCS). Technological advancements, including device miniaturization, are advancing the field of neuromodulation. ⋯ This clinical study demonstrated profound leg and low back pain relief in terms of overall pain reduction, as well as the proportion of therapy responders. The study patients reported the wearable aspects of the system to be very comfortable.
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Randomized Controlled Trial Multicenter Study
Effect of perioperative pain neuroscience education in people undergoing surgery for lumbar radiculopathy: a multicentre randomised controlled trial.
Perioperative education should be improved to decrease unfavourable outcomes after lumbar surgery. This trial aimed to compare effectiveness in terms of pain, quality of life, pain cognition, surgical experience, healthcare use, work resumption, and cost-effectiveness of perioperative pain neuroscience education (PPNE) vs traditional biomedical education (perioperative biomedical education [PBE]) in people undergoing surgery for lumbar radiculopathy. ⋯ NCT02630732.