Articles: back-pain.
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Contemp Clin Trials · Nov 2015
Randomized Controlled TrialLumbar Imaging With Reporting Of Epidemiology (LIRE)--Protocol for a pragmatic cluster randomized trial.
Diagnostic imaging is often the first step in evaluating patients with back pain and likely functions as a "gateway" to a subsequent cascade of interventions. However, lumbar spine imaging frequently reveals incidental findings among normal, pain-free individuals suggesting that treatment of these "abnormalities" may not be warranted. Our prior work suggested that inserting the prevalence of imaging findings in patients without back pain into spine imaging reports may reduce subsequent interventions. We are now conducting a pragmatic cluster randomized clinical trial to test the hypothesis that inserting this prevalence data into lumbar spine imaging reports for studies ordered by primary care providers will reduce subsequent spine-related interventions. ⋯ If our study shows that adding prevalence data to spine imaging reports decreases subsequent back-related RVUs, this intervention could be easily generalized and applied to other kinds of testing, as well as other conditions where incidental findings may be common. Our study also serves as a model for cluster randomized trials that are minimal risk and highly pragmatic.
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Randomized Controlled Trial
Effects of a prehabilitation program on patients' recovery following spinal stenosis surgery: study protocol for a randomized controlled trial.
Degenerative lumbar spinal stenosis is a prevalent condition in adults over the age of 65 and often leads to deconditioning. Although the benefits of surgery outweigh those of conservative approaches, physical rehabilitation may be used to improve function and to minimize the risk of persistent dysfunction. This study protocol was designed to establish the feasibility of a full-scale randomized controlled trial and to assess the efficacy of an active preoperative intervention program on the improvement of clinical parameters and functional physical capacity in patients undergoing surgery for lumbar spinal stenosis. ⋯ This study will inform the design of a future large-scale trial. Improvements of physical performances before undergoing lumbar surgery may limit functional limitations occurring after a surgical intervention. Results of this study will provide opportunity to efficiently improve spinal care and advance our knowledge of favorable preoperative strategies to optimize postoperative recovery.
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Randomized Controlled Trial Comparative Study
Comparison of fentanyl versus meperidine as supplements to epidural clonidine-bupivacaine in patients with lower limb orthopedic surgery under combined spinal epidural anesthesia.
The analgesic and sedative effect of clonidine explain its common use as adjuvant in regional anesthesia, however the hemodynamic instability associated with its neuroaxial administration is the major drawback. Our study hypothesis is to compare the hemodynamic and analgesic effect of epidural fentanyl in comparison to meperidine when added to clonidine in patients undergoing lower limbs orthopedic surgery using combined spinal-epidural anesthesia. ⋯ The combined administration of epidural clonidine and meperidine provided better intraoperative hemodynamics and prolonged postoperative analgesia than epidural clonidine fentanyl combination in patients undergoing lower limb orthopedic surgery.
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Randomized Controlled Trial Multicenter Study
Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial.
Current treatments for chronic pain have limited effectiveness and commonly known side effects. Given the prevalence and burden of intractable pain, additional therapeutic approaches are desired. Spinal cord stimulation (SCS) delivered at 10 kHz (as in HF10 therapy) may provide pain relief without the paresthesias typical of traditional low-frequency SCS. The objective of this randomized, parallel-arm, noninferiority study was to compare long-term safety and efficacy of SCS therapies in patients with back and leg pain. ⋯ HF10 therapy promises to substantially impact the management of back and leg pain with broad applicability to patients, physicians, and payers.
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
COMParative Early Treatment Effectiveness between physical therapy and usual care for low back pain (COMPETE): study protocol for a randomized controlled trial.
Low back pain is among the leading causes of medical visits and lost duty days among members of the United States Armed Forces and represents the highest 5-year risk of permanent disability in the US Army. For certain elements of care, the timing may be just as important as the type of care. The purpose of this study is to assess the impact of the timing of access to a physical therapist by patients with low back pain, by looking at outcomes and low back pain-related healthcare utilization over a 1-year period. ⋯ This trial takes a pragmatic approach to delivering care by enabling a usual care environment for managing low back pain, while also allowing immediate access to physical therapy. After the initial intervention, the patient's primary provider can continue to manage the patient as he/she normally would in practice. The Military Health System Data Repository will capture all low back pain-related healthcare utilization that occurs in order to allow for a comparison between groups. Analysis from retrospective cohorts has shown improved outcomes and decreased costs for patients that received early versus late physical therapy, but this has yet to be shown in prospective trials.