Articles: low-back-pain.
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Low back pain (LBP) is a major problem in modern society and it is important to study possible risk factors for this disorder. People with diabetes are often affected by LBP, but whether diabetes represents a risk factor for LBP has not been studied in detail. The aim of this study was to explore the association between diabetes and subsequent risk of chronic LBP. ⋯ Men with a diagnosis of diabetes may have a higher risk of subsequently experiencing chronic LBP.
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Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that investigate the effects of targeting lifestyle risk factors in people with chronic low back pain. ⋯ This study was approved by the Hunter New England Research Ethics Committee (Approval No 17/02/15/4.05), and the University of Newcastle Human Research Ethics Committee (Ref No H-2017-0222). Outcomes of this trial and supplementary analyses will be disseminated through publications in peer-reviewed journals and conference presentations.
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Multicenter Study
Can quantitative sensory tests predict failed back surgery?: A prospective cohort study.
Failed back surgery syndrome (FBSS) is a pain condition refractory to therapy, and is characterised by persistent low back pain after spinal surgery. FBSS is associated with severe disability, low quality of life and high unemployment. We are currently unable to identify patients who are at risk of developing FBSS. Patients with chronic low back pain may display signs of central hypersensitivity as assessed by quantitative sensory tests (QST). This can contribute to the risk of developing persistent pain after surgery. ⋯ The study indicates that assessment of altered central pain processing using current QST is unlikely to identify patients at risk of FBSS and is therefore unlikely to inform clinical decisions.
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Randomized Controlled Trial
Assessment of potentially abuse-related events in two phase 3 studies of NKTR-181, a novel opioid analgesic, using the MADDERS® system (Misuse, Abuse, and Diversion Drug Event Reporting System).
Objective: To prospectively evaluate the abuse potential of NKTR-181, a novel opioid analgesic, in two phase 3 clinical trials using a newly developed reporting system: the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS®). Methods: SUMMIT-07 was an enriched enrollment randomized withdrawal study that examined the safety and efficacy of NKTR-181 across 12 weeks in opioid-naïve subjects with chronic low back pain. SUMMIT-LTS was a 52 week open-label study in opioid-naïve and experienced subjects with chronic low back pain or noncancer pain rolled over from SUMMIT-07 or enrolled de novo. ⋯ Most events were attributed to "Withdrawal" and, primarily in SUMMIT-07, "Therapeutic Error" (unintentional overuse) or "Misuse" (intentional overuse for a therapeutic purpose) of study medication. Adjudicators identified five possible "Abuse" events (three NKTR-181, two placebo) in SUMMIT-07 and four possible "Abuse" events (all NKTR-181) in SUMMIT-LTS. Conclusions: The MADDERS® system discerns potentially abuse-related events and identified low rates of withdrawal and a low risk of abuse potential, diversion or addiction associated with NKTR-181 in phase 3 trials.
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To discuss the current knowledge on the impact of commonly used biologic agents (i.e., anti-tumor necrosis factor-alpha [anti-TNF-α] and anti-nerve growth factor [anti-NGF]) in the management of low back pain with or without sciatica. ⋯ Overall, anticytokine treatments have limited efficacy in patients with chronic low back pain with or without sciatica. However, larger and better-designed studies may need to be performed in specific patient subpopulations. Low back pain is particularly disabling in younger patients. This group therefore represents a potential target population for investigating the effectiveness of anticytokine therapies, especially where other pharmacological and nonpharmacological management strategies have failed.