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Abstract Background Orthopedic trauma injury impacts nearly 2.8 million people each year. Despite surgical improvements and excellent survivorship rates, many patients experience poor quality of life (QOL) outcomes years later. Psychological distress commonly occurs after injury. Distressed patients more frequently experience rehospitalizations, pain medication dependence, and low QOL. This study was developed to test whether an integrative care approach (IntCare; ten-step program of emotional support, education, customized resources, and medical care) was superior to usual care (UsCare). The primary aim was to assess patient functional QOL (objective and patient-reported outcomes) with secondary objectives encompassing emotional wellbeing and hospital outcomes. The primary outcome was the Lower Extremity Gain Scale score. Methods/design A single-blinded, single-center, repeated measures, randomized controlled study is being conducted with 112 orthopedic trauma patients aged 18–85 years. Patients randomized to the IntCare group have completed or are receiving a guided ten-step support program during acute care and at follow-up outpatient visits. The UsCare group is being provided the standard of care. Patient-reported outcomes and objective functional measures are collected at the hospital and at weeks 2, 6, and 12 and months 6 and 12 post surgery. The main study outcomes are changes in Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires of Physical Function quality of life, Satisfaction with Social Roles, and Positive-Illness Impact, Post-Traumatic Stress Disorder Check List, and the Tampa Scale of Kinesiophobia-11 from baseline to month 12. Secondary outcomes are changes in objective functional measures of the Lower Extremity Gain Scale, handgrip strength, and range of motion of major joints from week 2 to month 12 post surgery. Clinical outcomes include hospital length of stay, medical complications, rehospitalizations, psychological measures, and use of pain medications. A mixed model repeated measures approach assesses the main effects of treatment and time on outcomes, as well as their interaction (treatment × time). Discussion The results from this study will help determine whether an integrative care approach during recovery from traumatic orthopedic injury can improve the patient perceptions of physical function and emotional wellbeing compared to usual trauma care. Additionally, this study will assess the ability to reduce the incidence or severity of psychological distress and mitigate medical complications, readmissions, and reduction of QOL after injury. Trial registration ClinicalTrials.gov, NCT02591472 . Registered on 28 October 2015.

Abstract Background Atraumatic lower limb amputation is a life-changing event for approximately 185,000 persons in the United States each year. A unilateral amputation is associated with rapid changes to the musculoskeletal system including leg and back muscle atrophy, strength loss, gait asymmetries, differential mechanical joint loading and leg length discrepancies. Even with high-quality medical care and prostheses, amputees still develop secondary musculoskeletal conditions such as chronic low back pain (LBP). Resistance training interventions that focus on core stabilization, lumbar strength and dynamic stability during loading have strong potential to reduce LBP and address amputation-related changes to the musculoskeletal system. Home-based resistance exercise programs may be attractive to patients to minimize travel and financial burdens. Methods/design This study will be a single-assessor-blinded, pre-post-test randomised controlled trial involving 40 men and women aged 18–60 years with traumatic, unilateral transtibial amputation. Participants will be randomised to a home-based, resistance exercise group (HBRX) or a wait-list control group (CON). The HBRX will consist of 12 weeks of elastic resistance band and bodyweight training to improve core and lumbopelvic strength. Participants will be monitored via Skype or Facetime on a weekly basis. The primary outcome will be pain severity (11-point Numerical Pain Rating Scale; NRSpain). Secondary outcomes will include pain impact on quality of life (Medical Outcomes Short Form 36, Oswestry Disability Index and Roland Morris Disability Questionnaire), kinematics and kinetics of walking gait on an instrumented treadmill, muscle morphology (muscle thickness of multifidus, transversus abdominis, internal oblique), maximal muscle strength of key lumbar and core muscles, and daily step count. Discussion The study findings will determine whether a HBRX program can decrease pain severity and positively impact several physiological and mechanical factors that contribute to back pain in unilateral transtibial amputees with chronic LBP. We will determine the relative contribution of the exercise-induced changes in these factors on pain responsiveness in this population. Trial registration ClinicalTrials.gov, ID: NCT03300375 . Registered on 2 October 2017.