European journal of pain : EJP
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Randomized Controlled Trial
Efficacy and safety of co-crystal of tramadol-celecoxib (CTC) in acute moderate-to-severe pain after abdominal hysterectomy: A randomized, double-blind, phase 3 trial (STARDOM2).
STARDOM2 is a randomized, double-blind, phase 3 trial evaluating the efficacy and safety of co-crystal of tramadol-celecoxib (CTC)-a first-in-class analgesic co-crystal comprising racemic tramadol hydrochloride and celecoxib in a supramolecular network that modifies their pharmacokinetic properties-for the management of acute postoperative pain (NCT03062644; EudraCT:2016-000593-38). ⋯ In the randomized, double-blind, phase 3 STARDOM2 trial-in acute moderate-to-severe pain after abdominal hysterectomy-the novel co-crystal of tramadol-celecoxib (CTC) 200 mg BID was superior to placebo and non-inferior to tramadol 100 mg QID. Although superiority to tramadol was not reached, CTC 200 mg BID exposed patients to lower cumulative opioid (tramadol) doses than tramadol (100 mg QID) alone, with fewer treatment-emergent adverse events. CTC 200 mg thus has a clinically relevant improved benefit/risk profile compared with tramadol alone.
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Controlled Clinical Trial
Short and long term effects of conventional spinal cord stimulation on chronic pain and health perceptions: a longitudinal controlled trial.
The effectiveness and long-term outcomes of spinal cord stimulation (SCS) are not fully established, especially considering that data from patients who withdrew from the trial are rarely analysed, which may lead to overestimation of SCS efficacy. We evaluated short- and long-term effects of SCS on chronic pain and perceived health, beyond natural variability in these outcomes. ⋯ This longitudinal study evaluated short and long term effects of spinal cord stimulation (SCS) on chronic pain outcome measures, beyond their natural variation in time. Despite significant short term improvements, by the end of the seven months' follow-up, the outcomes in the treatment group (people who received the permanent implantation) were similar to those of the control group (people whose SCS trial failed and did not continue to permanent implantation) suggesting SCS may not be cost-effective for chronic pain patients.
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A previously developed educational e-health tool considers both clinical and psychosocial factors when selecting patients with chronic pain for spinal cord stimulation (SCS). The validity of the composite recommendations was evaluated in a retrospective study, demonstrating a strong relationship with patient outcomes after SCS. ⋯ This study confirms the relevance of the psychosocial factors embedded in the educational SCS e-health tool (https://scstool.org/). The strong relationship between the severity of psychosocial factors with patient outcomes supports conducting a comprehensive psychological and behavioural assessment when determining the eligibility of patients for SCS.
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Few studies have explored the impact of low back or lower limb pain severity on recurrent (≥2) falls in older adults. ⋯ Severe low back pain, or severe lower limb pain is associated with an increased likelihood of recurrent falls in older males and females, and an increased likelihood of falls-related injuries in older female recurrent fallers. Assessment and management of severe low back and lower limb pain should be prioritized when undertaking falls-risk assessment. Future longitudinal research is required to further interrogate this relationship and its underlying mechanisms.