Extremity fractures are common, and most are managed operatively; however, despite successful reduction, up to half of patients report persistent post-surgical pain. Furthermore, psychological ...factors such as stress, distress, anxiety, depression, catastrophizing, and fear-avoidance behaviors have been associated with the development of chronic pain. The purpose of this pilot study was to examine the feasibility of a randomized controlled trial to determine the effect of in-person cognitive behavioral therapy (CBT) vs. usual care on persistent post-surgical pain among patients with a surgically managed extremity fracture.
Eligible patients were randomized to either in-person CBT or usual care. We used four criteria to judge the composite measure of feasibility: 1) successful implementation of CBT at each clinical site, 2) 40 patients recruited within 6 months, 3) treatment compliance in a minimum 36 of 40 participants (90%), and 4) 32 of 40 participants (80%) achieving follow-up at one year. The primary clinical outcome was persistent post-surgical pain at one year after surgery.
Only two of the four participating sites were able to implement the CBT regimen due to difficulties with identifying certified therapists who had the capacity to accommodate additional patients into their schedule within the required timeframe (i.e., 8 weeks of their fracture). Given the challenges associated with CBT implementation, only one site was able to actively recruit patients. This site screened 86 patients and enrolled 3 patients (3.5%) over a period of three months. Participants were unable to comply with the in-person CBT, with no participants attending an in-person CBT session. Follow-up at one year could not be assessed as the pilot study was stopped early, three months into the study, due to failure to achieve the other three feasibility criteria.
Our pilot trial failed to demonstrate the feasibility of a trial of in-person CBT versus usual care to prevent persistent pain after surgical repair of traumatic long-bone fractures and re-enforces the importance of establishing feasibility before embarking on definitive trials. Protocol modifications to address the identified barriers include the delivery of our intervention as a therapist-guided, remote CBT program.
ClinicalTrials.gov (Identifier NCT03196258); Registered June 22, 2017, https://clinicaltrials.gov/ct2/show/NCT03196258.
Background:
Intra-articular (IA) injections are commonly used to treat knee arthritis pain; however, whether their efficacy generalizes to ankle arthritis remains debatable. We aimed to evaluate the ...evidence for IA therapies in the management of this patient population.
Methods:
We performed a literature search for observational and randomized controlled trials (RCTs). Treatments included corticosteroids (CS), hyaluronic acid (HA), platelet-rich plasma (PRP), and mesenchymal stem cells (MSC). We extracted study details, patient demographics, treatment characteristics, efficacy outcomes, and safety. When feasible, data from RCTs were meta-analyzed using a random-effects model and 95% confidence intervals (CIs) were calculated. A P value <.05 was considered statistically significant.
Results:
We identified 27 studies (1085 patients). Ankle OA, rheumatoid arthritis (RA), and hemophilic arthropathy populations were examined. The majority of studies were observational (20 studies); the only RCTs were those evaluating HA. Case series demonstrated favorable results in terms of symptomatic relief with CS, HA, PRP, and MSC injections; however, the effects of CS may only be short term and the evidence on MSCs was limited to 1 study with 6 ankle OA patients. Pooled results (3 RCTs, 109 patients) suggested significantly improved Ankle Osteoarthritis Scale scores with HA over saline at 6 months, with a mean difference of 12.47 points (95% CI 1.18-23.77, P = .03).
Conclusion:
Evidence from small trials favors HA and PRP injections for the treatment of pain associated with ankle osteoarthritis. However, the relative efficacy of all injectable therapies is far from definitive and warrants further high-quality comparative trials.
Level of Evidence:
Level III, systematic review.
Injury in Brazilian Jiu-Jitsu Training Petrisor, Brad A.; Del Fabbro, Gina; Madden, Kim ...
Sports health,
09/2019, Letnik:
11, Številka:
5
Journal Article
Recenzirano
Odprti dostop
Background:
Brazilian jiu-jitsu (BJJ) is a grappling-based martial art that can lead to injuries both in training and in competition. There is a paucity of data regarding injuries sustained while ...training in BJJ, in both competitive and noncompetitive jiu-jitsu athletes.
Hypothesis:
We hypothesize that most BJJ practitioners sustain injuries to various body locations while in training and in competition. Our primary objective was to describe injuries sustained while training for BJJ, both in practice and in competition. Our secondary objectives were to classify injury type and to explore participant and injury characteristics associated with wanting to quit jiu-jitsu after injury.
Study Design:
Descriptive epidemiology study.
Methods:
We conducted a survey of all BJJ participants at a single club in Hamilton, Ontario, Canada. We developed a questionnaire including questions on demographics, injuries in competition and/or training, treatment received, and whether the participant considered discontinuing BJJ after injury.
Results:
A total of 70 BJJ athletes participated in this study (response rate, 85%). Ninety-one percent of participants were injured in training and 60% of competitive athletes were injured in competitions. Significantly more injuries were sustained overall for each body region in training in comparison with competition (P < 0.001). Two-thirds of injured participants required medical attention, with 15% requiring surgery. Participants requiring surgical treatment were 6.5 times more likely to consider quitting compared with those requiring other treatments, including no treatment (odds ratio OR, 6.50; 95% CI, 1.53-27.60). Participants required to take more than 4 months off training were 5.5 times more likely to consider quitting compared with those who took less time off (OR, 5.48; 95% CI, 2.25-13.38).
Conclusion:
The prevalence of injury is very high among BJJ practitioners, with 9 of 10 practitioners sustaining at least 1 injury, commonly during training. Injuries were primarily sprains and strains to fingers, the upper extremity, and neck. Potential participants in BJJ should be informed regarding significant risk of injury and instructed regarding appropriate precautions and safety protocols.
Clinical Relevance:
Clinicians should be aware of the substantial risk of injury among BJJ practitioners and the epidemiology of the injuries as outlined in this article.
Chronic, non-cancer pain affects approximately 20-30% of the population in North America, Europe, and Australia, with surgery and trauma frequently cited as inciting events. Prospective studies of ...fracture patients have demonstrated an association between somatic pre-occupation, poor coping, and low recovery expectations following surgery with persistent pain, functional limitations, and lower rates of return to work. Psychological interventions, such as cognitive behavioural therapy (CBT), that are designed to modify unhelpful beliefs and behaviours have the potential to reduce persistent post-surgical pain and its associated effects among trauma patients.
To determine whether online CBT, versus usual care, reduces the prevalence of moderate to severe persistent post-surgical pain among participants with an open or closed fracture of the appendicular skeleton.
The Cognitive Behavioural Therapy to Optimize Post-Operative Fracture Recovery (COPE) protocol will be followed to conduct a multi-centre randomized controlled trial. Participants undergoing surgical repair of a long bone fracture will be randomized to receive either (1) online CBT modules with asynchronous therapist feedback or (2) usual care. The primary outcome will be the prevalence of moderate to severe persistent post-surgical pain over 12 months post-fracture. Secondary outcomes include the Short Form-36 Physical and Mental Component Summary scores, return to function, pain severity and pain interference over 12 months post-fracture, and the proportion of patients prescribed opioid class medications (and average dose) at 6 and 12 months post-fracture. The COPE trial will enroll 1000 participants with open and closed fractures of the appendicular skeleton from approximately 10 hospitals in North America.
If CBT is effective in improving outcomes among patients with traumatic fractures, our findings will promote a new model of care that incorporates psychological barriers to recovery.
ClinicalTrials.gov Identifier: NCT04274530. Registered on 14 February 2020.
One third of women experience intimate partner violence (IPV) in their lifetime. Orthopaedic health care professionals are in a good position to identify women experiencing escalating physical ...violence and act to promote their immediate safety, connect them to IPV resources, and reduce the risk of further harm. However, there have been no studies that explore whether experiencing a musculoskeletal injury can trigger or worsen IPV, and there have been no studies on how experiences of IPV affect orthopaedic outcomes. The primary objective of the PRAISE-2 pilot study is to assess the feasibility of conducting a large cohort study to determine the association between IPV and injury-related complications. The secondary clinical objectives are to preliminarily explore how a history of IPV affects orthopaedic outcomes and how patterns of IPV change over time following an orthopaedic injury.
We will complete a pilot multicentre prospective cohort study of 250 women with musculoskeletal injuries to determine the feasibility of a multinational prospective cohort study that will determine if prior or ongoing IPV affects orthopaedic outcomes following an injury, and how patterns of IPV change over time. Our primary outcome is feasibility measured using recruitment rate (success criterion 50 patients/site in 12 months), adherence to visit windows (success criterion 75%), participant retention (success criterion 85%), and data completeness (success criterion 80%). Our secondary exploratory clinical outcomes are injury-related complications, return to function, new IPV disclosures, utilization and cost of support services, changes in abuse patterns, quality of life, and readiness to make relationship changes. We will assess feasibility based on pre-defined criteria for feasibility success and we will analyze secondary outcomes in an exploratory fashion.
The PRAISE-2 pilot study is the first step toward determining how experiences of IPV affect orthopaedic outcomes such as injury-related complications. This study will determine feasibility and assist in the development of large-scale multinational prospective IPV studies for our future IPV research program. This study will engage health care professionals from around the world to increase awareness of how IPV affects patients' musculoskeletal and injury outcomes.
clinicaltrials.gov NCT02529267. Registered 20 Aug 2015.
The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is ...standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair.
To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair.
The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders.
The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice.
ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.
Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before ...initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent.
The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have.
Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation.
Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.
Importance In response to the COVID-19 pandemic, many hospital systems were forced to reduce operating room capacity and reallocate resources. The outcomes of these policies on the care of injured ...patients and the maintenance of emergency services have not been adequately reported. Objective To evaluate whether the COVID-19 pandemic was associated with delays in urgent fracture surgery beyond national time-to-surgery benchmarks. Design, Setting, and Participants This retrospective cohort study used data collected in the Program of Randomized Trials to Evaluate Preoperative Antiseptic Skin Solutions in Orthopaedic Trauma among at 20 sites throughout the US and Canada and included patients who sustained open fractures or closed femur or hip fractures. Exposure COVID-19–era operating room restrictions were compared with pre–COVID-19 data. Main Outcomes and Measures Surgery within 24 hours after injury. Results A total of 3589 patients (mean SD age, 55 25.4 years; 1913 53.3% male) were included in this study, 2175 pre–COVID-19 and 1414 during COVID-19. A total of 54 patients (3.1%) in the open fracture cohort and 407 patients (21.8%) in the closed hip/femur fracture cohort did not meet 24-hour time-to-surgery benchmarks. We were unable to detect any association between time to operating room and COVID-19 era in either open fracture (odds ratio OR, 1.40; 95% CI, 0.77-2.55;P = .28) or closed femur/hip fracture (OR, 1.01; 95% CI, 0.74-1.37;P = .97) cohorts. In the closed femur/hip fracture cohort, there was no association between time to operating room and regional COVID-19 prevalence (OR, 1.07; 95% CI, 0.70-1.64;P = .76). Conclusions and Relevance In this cohort study, there was no association between meeting time-to-surgery benchmarks in either open fracture or closed femur/hip fracture during the COVID-19 pandemic compared with before the pandemic. This is counter to concerns that the unprecedented challenges associated with managing the COVID-19 pandemic would be associated with clinically significant delays in acute management of urgent surgical cases and suggests that many hospital systems within the US were able to effectively implement policies consistent with time-to-surgery standards for orthopedic trauma in the context of COVID-19–related resource constraints.
Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility ...criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow.
Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients.
7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p < 0.001).
Implementing a sampling strategy in the PREPARE trial has helped to limit the number of missed eligible patients. This sampling strategy represents a simple, easy to use tool for managing work flow at clinical sites and maintaining the integrity of a large trial.
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