Pain practice : the official journal of World Institute of Pain
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Randomized Controlled Trial Multicenter Study
Sustained safety and efficacy of once-daily hydromorphone extended-release (OROS® hydromorphone ER) compared with twice-daily oxycodone controlled-release over 52 weeks in patients with moderate to severe chronic noncancer pain.
Once-daily hydromorphone extended-release (OROS(®) hydromorphone ER) and oxycodone controlled-release (CR) are semisynthetic, ER opioid analgesics with established efficacy. An open-label, randomized, 24-week, parallel group, flexible-dose study demonstrated noninferiority of OROS hydromorphone ER vs. twice-daily oxycodone CR in patients with chronic noncancer pain. In total, 112 patients were enrolled in a 28-week, open-label extension study; 60 patients received OROS hydromorphone ER and 52 received oxycodone CR. ⋯ At Week 52, global assessment of efficacy was rated as "very good" or "good" by the majority of patients (OROS hydromorphone ER, 91.7%; oxycodone CR, 86.5%). More patients in the OROS hydromorphone ER group (35.0% vs. 21.2%) assessed mode of drug intake as "very convenient." The majority of patients receiving OROS hydromorphone ER (88.3%) and oxycodone CR (88.5%) rated tolerability as "good" or "very good" at Week 52; few patients discontinued treatment because of an adverse event (1.6% vs. 0.4%, respectively). The effectiveness of OROS hydromorphone ER and oxycodone CR was maintained through 1 year.
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Randomized Controlled Trial Multicenter Study
Results of a double-blind, placebo-controlled, fixed-dose assessment of once-daily OROS® hydromorphone ER in patients with moderate to severe pain associated with chronic osteoarthritis.
Opioids are recommended for patients with moderate to severe pain due to osteoarthritis (OA), who do not receive adequate analgesia from nonopioid treatment. The objective of this study was to evaluate the efficacy and safety of OROS hydromorphone extended-release (ER) compared with placebo in patients with moderate to severe pain associated with OA. ⋯ OROS hydromorphone ER failed to achieve statistical significance for the primary endpoint using the prespecified imputation method (BOCF), likely due to the high discontinuation rate associated with the fixed-dose design. When data were analyzed according to an alternate method of imputation (LOCF), OROS hydromorphone ER demonstrated statistically significant improvements in pain, stiffness, and physical function.
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Previous studies demonstrated the efficacy of Intramuscular Nerve (IMN) therapy with a 4-lead percutaneous, peripheral nerve stimulation (PNS) system in reducing hemiplegic shoulder pain (HSP). This case series investigates the feasibility of a less complex, single-lead approach in reducing HSP. ⋯ This case series demonstrates the feasibility of a single-lead, 3-week IMN therapy for the treatment of chronic HSP. Additional studies are needed to further demonstrate safety, efficacy, and long-term benefit, define optimal prescriptive parameters and dose, and expand clinical indications.
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Case Reports
Yoga spinal flexion positions and vertebral compression fracture in osteopenia or osteoporosis of spine: case series.
The objective of this report is to raise awareness of the effect of strenuous yoga flexion exercises on osteopenic or osteoporotic spines. We previously described subjects with known osteoporosis in whom vertebral compression fractures (VCFs) developed after spinal flexion exercise (SFE) and recommended that SFEs not be prescribed in patients with spinal osteoporosis. ⋯ The development of pain and complications with some flexion yoga positions in the patients with osteopenia leads to concern that fracture risk would increase even further in osteoporosis. Although exercise has been shown to be effective for improving bone mineral density and decreasing fracture risk, our subjects had development of VCFs and neck and back pain with yoga exercises. This finding suggests that factors other than bone mass should be considered for exercise counseling in patients with bone loss. The increased torque pressure applied to vertebral bodies during SFEs may be a risk. Exercise is effective and important for treatment of osteopenia and osteoporosis and should be prescribed for patients with vertebral bone loss. Some yoga positions can contribute to extreme strain on spines with bone loss. Assessment of fracture risk in older persons performing SFEs and other high-impact exercises is an important clinical consideration.
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Editorial Comment
Pelvic pain: mechanistically enigmatic, therapeutically challenging.