Cervical Myelopathy, Cervical Spondylosis and Spondylolisthesis, Chronic Low Back Pain, Lumbar Spondylolisthesis, Lumbar Spondylosis, Medium-/Long-segment Spinal Fusion Patients, Post Laminectomy Cervical Syndrome, Scoliosis Patients, Spine Surgeons
Conditions
Keywords
back surgery, medium-/long-segment spinal fusion, mindfulness, Perioperative Care, Whole Person Care, Chronic low back pain, Feasibility, Qualitative
Brief summary
Chronic back pain is the world's leading cause of disability, with spine surgery being a common yet costly intervention. However, many patients experience suboptimal recovery, with persistent pain and functional limitations contributing to high healthcare utilization and costs. Traditional surgical pathways often overlook the role of mental well-being and patient engagement in recovery. However, research indicates that interventions promoting self-management and stress reduction can lead to improvements in pain, faster recovery, and reduced hospital readmissions. Evidence shows that preoperative psychosocial factors, such as anxiety and depression, significantly predict post-surgical outcomes, yet structured perioperative support is lacking. To address this gap, Ready Set Recover (RSR), a mobile health (mHealth) intervention, provides education, behavioral strategies, and psychosocial support to enhance surgical preparedness and optimize post-surgical recovery. By addressing both psychological and behavioral factors, RSR has the potential to fill a critical gap in perioperative care. As a scalable digital platform, RSR offers an accessible, cost-effective solution that can be easily integrated into existing surgical care models, reducing the burden on healthcare providers while empowering patients to take an active role in their healing process. RSR aims to accomplish this by integrating evidence-based components such as cognitive behavioral therapy, mindfulness, gratitude practices, and guided movement to foster patient empowerment and sustainable health practices in the pre- and post-surgical periods. The platform provides patients with a structured and flexible tool to improve self-efficacy, adherence to post-surgical recommendations, and the overall surgical recovery experience. This study aims to evaluate the feasibility and acceptability of RSR through an explanatory mixed-methods pilot randomized controlled trial (RCT) in patients undergoing medium-to-long segment spinal fusion at Oregon Health & Science University. Aim 1 assesses feasibility and acceptability by measuring patient engagement, intervention completion rates, and satisfaction. Aim 2 qualitatively evaluate barriers and facilitators to implementation of RSR within the clinic setting via provider, patient, and clinic stakeholder semi-structured interviews. Aim 3 establishes a patient community advisory board (CAB) to guide future research and the development of a Phase II Small Business Technology Transfer (STTR) efficacy trial. Findings from this study will inform the refinement and scalability of RSR as a low-burden, cost-effective solution to improve surgical outcomes. Insights gained from this research may extend beyond spine surgery, informing the development of digital health interventions for other surgical populations, ultimately advancing patient-centered, technology-driven approaches to perioperative care.
Interventions
BEHAVIORALReady Set Recover
Ready Set Recover is a peri-operative mHealth platform designed to help patients prepare for and recover from surgery. RSR empowers patients to be a self-advocate in their surgical journey, plan appropriately for surgery day, garner support from loved ones, and maintain healthy lifestyle practices including: spending time in nature, mindfulness practices and stress reduction, gratitude practice, and post-surgical mindful movement. These activities encourage intrinsically motivated, sustainable behavior change that supports surgical recovery.
Sponsors
National University of Natural Medicine
Oregon Health and Science University
READY SET RECOVER, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Mixed methods study involving a1:1 randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients deemed candidates for medium-/long-segment spinal fusion * Patients who score a \> 4 on a 0-10 NRS for the question "How motivated are you to participate in this research study?" * At least 18 years of age and not older than 80 at the time of study enrollment •Ability to read and understand English * Daily access to the internet via cell phone, tablet, or computer
Exclusion criteria
* Have received epidural steroid injection for low back pain, lumbosacral radiculopathy, or scoliosis in the prior 3 months * Have received a surgical intervention for low back pain, lumbosacral radiculopathy, or scoliosis in the previous 6 months * Concurrent diagnosis of cancer * Cognitive impairment * Severe comorbidities (e.g., terminal illness, severe organ failure) * Non-elective/emergency surgery in the past
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Retention | 30 days post-surgery | Measured using a participant tracking spreadsheet |
| Adverse Events (AEs) | Daily from baseline through end of intervention (30 days post surgery) | The study team will regularly monitor for adverse events via the daily survey. In addition to reporting adverse events to the IRB, the investigators will regularly review adverse events at each study meeting in order to rapidly address these events and to facilitate early recognition of any emerging patterns. |
| Feasibility of enrollment | Data collected during screening and enrollment process | Enrollment Rate: Measured using a participant tracking spreadsheet. |
| Feasibility of Adherence | Daily from baseline through end of intervention (30 days post surgery) | Measured through completion with the RSR daily actions and educational materials. |
| Acceptability and Accessibility | 30- days post surgery | Measured through the qualitative study exit interview and the Client Satisfaction Questionnaire. |
Countries
United States
Contacts
CONTACTRyan Wexler Assistant Research Investigator, ND, MSRC
CONTACTDana Dharmakaya Colgan Assistant Professor, PhD
Outcome results
None listed