IntroductionFracture healing can fail in up to 10% of cases despite appropriate treatment. While lithium has been the standard treatment for bipolar disorder, it may also have a significant impact to increase bone healing in patients with long bone fractures. To translate this knowledge into clinical practice, a randomised clinical trial (RCT) is proposed.Methods and analysisA multicentre double blind, placebo-controlled RCT is proposed to evaluate the efficacy of lithium to increase the rate and predictability of long bone fracture healing in healthy adults compared to lactose placebo treatment. 160 healthy individuals from 18 to 55 years of age presenting with shaft fractures of the femur, tibia/fibula, humerus or clavicle will be eligible. Fractures will be randomised to placebo (lactose) or treatment (300 mg lithium carbonate) group within 2 weeks of the injury. The primary outcome measure will be radiographic union defined as visible callus bridging on three of the four cortices at the fracture site using a validated radiographic union score. Secondary outcome measures will include functional assessment and pain scoring.Ethics and disseminationParticipant confidentiality will be maintained with publication of results. Research Ethics Board Approval: Sunnybrook Research Institute (REB # 356–2016). Health Canada Approval (HC6-24-C201560). Results of the main trial and secondary endpoints will be submitted for publication in a peer-reviewed journal and presented at conferences.Trial registration numberNCT02999022.
Background: Recovery and rehabilitation following surgery can take many months. Understanding what patients can do to facilitate recovery would be beneficial for spinal surgeons. This study sought to evaluate the impact of exercise practice, before and after surgery, on long-term outcomes of spine surgery in a robust clinical sample. Methods: This prospective longitudinal cohort study included adult patients undergoing spinal surgery for degenerative spinal conditions. Patients were administered a survey that included preoperative and postoperative exercise practices and the following patient-reported outcome measures: the physical component score (PCS) and mental component score (MCS) of the Medical Outcomes Study 36-Item Short Form Survey (Rand-36), the Oswestry Disability Index (ODI) score, the Numeric Rating Scale (NRS) score for pain and the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form score. Random effects models investigated the relationship of exercise, follow-up time and their interaction in predicting each patient-reported outcome measure over time, with and without sociodemographic covariates. Results: There were 168 patients in the study sample with up to 12 months of follow-up data. Analysis revealed modest significant main effects of exercise on PCS, MCS, ODI and PROMIS scores and main effects of time on all outcomes. The exercise-by-time interaction was significant in predicting the trajectories of the ODI and MCS scores. When full models were adjusted for education and employment status, interaction effects were no longer significant, but exercise main effects remained significant for ODI score. Conclusion: Patients who engage in exercise before and after spine surgery have better mental health and spine-specific recovery trajectories than those who do not. All health care providers should encourage patients to exercise while they are waiting for surgery within preoperative limitations and as soon as they are able after surgery and to continue this over the long term.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.