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Abstract Background Chronic low back pain (cLBP) is widespread, costly, and burdensome to patients and health systems. Little is known about non-pharmacological treatments for the secondary prevention of cLBP. There is some evidence that treatments addressing psychosocial factors in higher risk patients are more effective than usual care. However, most clinical trials on acute and subacute LBP have evaluated interventions irrespective of prognosis. Methods We have designed a phase 3 randomized trial with a 2 × 2 factorial design. The study is also a Hybrid type 1 trial with focus on intervention effectiveness while simultaneously considering plausible implementation strategies. Adults (n = 1000) with acute/subacute LBP at moderate to high risk of chronicity based on the STarT Back screening tool will be randomized in to 1 of 4 interventions lasting up to 8 weeks: supported self-management (SSM), spinal manipulation therapy (SMT), both SSM and SMT, or medical care. The primary objective is to assess intervention effectiveness; the secondary objective is to assess barriers and facilitators impacting future implementation. Primary effectiveness outcome measures are: (1) average pain intensity over 12 months post-randomization (pain, numerical rating scale); (2) average low back disability over 12 months post-randomization (Roland-Morris Disability Questionnaire); (3) prevention of cLBP that is impactful at 10–12 months follow-up (LBP impact from the PROMIS-29 Profile v2.0). Secondary outcomes include: recovery, PROMIS-29 Profile v2.0 measures to assess pain interference, physical function, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities. Other patient-reported measures include LBP frequency, medication use, healthcare utilization, productivity loss, STarT Back screening tool status, patient satisfaction, prevention of chronicity, adverse events, and dissemination measures. Objective measures include the Quebec Task Force Classification, Timed Up & Go Test, the Sit to Stand Test, and the Sock Test assessed by clinicians blinded to the patients’ intervention assignment. Discussion By targeting those subjects at higher risk this trial aims to fill an important gap in the scientific literature regarding the effectiveness of promising non-pharmacological treatments compared to medical care for the management of patients with an acute episode of LBP and the prevention of progression to a severe chronic back problem. Trial registration ClinicalTrials.gov Identifier: NCT03581123.

Abstract Background Despite similar outcomes for surgery and conservative care, the number of surgeries to treat rotator cuff related shoulder pain has increased. Interventions designed to enhance treatment expectations for conservative care have been shown to improve patient expectations, but no studies have yet explored whether such interventions influence patient decisions to pursue surgery. The purpose of this randomized clinical trial is to examine the effect of an intervention designed to improve expectations of conservative care on the decision to have surgery. Methods We will test the effectiveness of the Patient Engagement, Education, and Restructuring of Cognitions (PEERC) intervention which is intended to change expectations regarding conservative care. The PEERC intervention will be evaluated in a randomized, pragmatic “add-on” trial, to better understand the effect the intervention has on outcomes. Ninety-four (94) participants with rotator cuff related shoulder pain referred for physical therapy will be randomized to receive either impairment-based care or impairment-based care plus PEERC. Both groups will receive impairment-based conservative treatment created by compiling the evidence associated with established, effective interventions. Participants assigned to the impairment-based care plus PEERC condition will also receive the PEERC intervention. This intervention, informed by principles of cognitive behavioral therapy, involves three components: (1) strategies to enhance engagement, (2) education and (3) cognitive restructuring and behavioral activation. Outcomes will be assessed at multiple points between enrolment and six months after discharge. The primary outcome is patient reported decision to have surgery and the secondary outcomes are pain, function, expectations and satisfaction with conservative care. Discussion Rotator cuff related shoulder pain is highly prevalent, and because conservative and surgical treatments have similar outcomes, an intervention that changes expectations about conservative care could alter patient reports of their decision to have surgery and ultimately could lead to lower healthcare costs and decreased risk of surgical complications. Trial registration This study is registered as NCT03353272 at ClincialTrials.gov.

Abstract Background Although education, exercise, and weight loss are recommended for management of knee osteoarthritis, the additional benefits of incorporating weight loss strategies into exercise interventions have not been well investigated. The aim of this study is to compare, in a private health insurance setting, the clinical- and cost-effectiveness of a remotely-delivered, evidence- and theory-informed, behaviour change intervention targeting exercise and self-management (Exercise intervention), with the same intervention plus active weight management (Exercise plus weight management intervention), and with an information-only control group for people with knee osteoarthritis who are overweight or obese. Methods Three-arm, pragmatic parallel-design randomised controlled trial involving 415 people aged ≥45 and ≤ 80 years, with body mass index ≥28 kg/m2 and