Evaluation of an Online Peri-operative Health Education Platform for Patients Undergoing Spine Surgery: Ready Set Recover

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational University of Natural Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ready Set Recover

    Behavioral

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Surgery + Standard of CareNo intervention 0 interventions
Group B: Surgery+RSRExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of Retention

Measured using a participant tracking spreadsheet

Time frame
30 days post-surgery
2

Adverse Events (AEs)

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.

Time frame
Daily from baseline through end of intervention (30 days post surgery)
3

Feasibility of enrollment

Enrollment Rate: Measured using a participant tracking spreadsheet.

Time frame
Data collected during screening and enrollment process
4

Feasibility of Adherence

Measured through completion with the RSR daily actions and educational materials.

Time frame
Daily from baseline through end of intervention (30 days post surgery)

Secondary outcomes

Other outcomes

1

Visual Analog Scale for Pain Back Pain Intensity

The NRS is a self-reported scale where participants will be asked to report their pain intensity on a scale from 0 to 10 (0 = "no pain", 10 = "worst pain").

Time frame
Daily from baseline through end of intervention (30 days post surgery)
2

Modified Oswestry Disability Index (ODI)

Designed to assess the impact of pain on participants' ability to perform activities of daily living such as personal care, lifting, walking, and sitting. 0 to 100% (raw 0-50 points), with lower scores indicating better function.

Time frame
30 Days Pre-surgery and 30 Days Post-surgery
3

Central Sensitization Inventory (CSI)

Participants' pain experiences specifically related to hypersensitivity and allodynia to discern whether an individual may experience central sensitization. Scores range from 0 to 100, with higher scores indicating greater central sensitization-related symptom burden.

Time frame
30 Days Pre-surgery and 30 Days Post-surgery
4

Tampa Scale of Kinesiophobia

The TSK-11 is designed to assess for the presence of fear of movement. Scores range from 11-44 (11 items, 4-point Likert 1 = strongly disagree to 4 = strongly agree). Higher scores indicate greater fear of movement/(re)injury

Time frame
30 Days Pre-surgery and 30 Days Post-surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Natural Medicine

Lead sponsor

Oregon Health and Science University

Collaborator

READY SET RECOVER, LLC

Collaborator

This trial is not recruiting at the moment. You can still explore other options: