An Early Phase 1 interventional study of Ready Set Recover in Medium-/Long-segment Spinal Fusion Patients, Spine Surgeons and Chronic Low Back Pain, sponsored by National University of Natural Medicine. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by National University of Natural Medicine · Early Phase 1, Interventional, and Other
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.
Exclusion Criteria:
Surgery + Standard of care is defined as instrumented spinal fusion with routine perioperative care, including preoperative information, postoperative mobilization, and standard analgesia.
Spinal Fusion + Ready 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.
Behavioral: Ready 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.
Feasibility of Retention
Measured using a participant tracking spreadsheet
Time frame: 30 days post-surgery
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)
Feasibility of enrollment
Enrollment Rate: Measured using a participant tracking spreadsheet.
Time frame: Data collected during screening and enrollment process
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)
Acceptability and Accessibility
Measured through the qualitative study exit interview and the Client Satisfaction Questionnaire.
Time frame: 30- days post surgery
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)
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
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
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
Pain Catastrophizing Scale (PCS)
The PCS is ubiquitously used to assess pain catastrophizing via its subscales: helplessness, rumination, and magnification. Scores range from 0-52 (13 items, each 0 = not at all to 4 = all the time). Higher = greater catastrophizing.
Time frame: 30 Days Pre-surgery and 30 Days Post-surgery
Pain Self-efficacy Questionnaire (PSEQ)
The PSEQ is designed to assess participants perceived ability and confidence to manage their pain. Scores range from 0-60 (10 items, 0 = not at all confident to 6 = completely confident). Higher scores indicate greater pain self-efficacy.
Time frame: 30 Days Pre-surgery and 30 Days Post-surgery
PROMIS Ability to Participate in Social Roles
The ability to participate in social roles questionnaire is a PROMIS measure designed to evaluate the impact of a condition on social engagement. It uses a T-score metric, mean 50 ± 10 (US general population); practical range \~20-80 . Higher scores indicate better social participation; \<40 = moderate-severe impairment.
Time frame: 30 Days Pre-surgery and 30 Days Post-surgery
Brief Pain Inventory (BPI)
The BPI has previously been used to assess pain interference in patients with chronic pain and is the most frequently used measure of pain interference in trials of MORE. Scores range from 0-10 (mean of 7 items). Higher scores indicate worse interference; MCID ≥1-point improvement.
Time frame: 30 Days Pre-surgery and 30 Days Post-surgery
Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale (PEB):
The PEB is designed to assess patients' beliefs about the biopsychosocial model of chronic pain. Includes 11 items, unidimensional. Higher scores indicate greater endorsement of a biopsychosocial pain model, associated with greater readiness for/engagement in self-management.
Time frame: 30 Days Pre-surgery and 30 Days Post-surgery
Patient Reported Outcomes Measurement Information System (PROMIS)-29:
The PROMIS- 29 assesses an individual's overall quality of life using self-reporting questions in domains such as physical function, anxiety, depression, fatigue, sleep disturbance. Each of 7 domains scored as a T-score, mean 50 ± 10; plus single 0-10 pain intensity item Direction is domain-dependent. Higher scores indicate better physical function and ability to participate in social roles and activities. Lower scores are better in anxiety, depression, fatigue, sleep disturbance, pain interference subscales.
Time frame: 30 Days Pre-surgery and 30 Days Post-surgery
Perioperative Anxiety Scale-7 (PAS-7)
The peri-operative anxiety scale was developed in collaboration with psychiatrists, anesthesiologists, and surgeons to assess mental and somatic symptoms of pre-operative anxiety.
Time frame: 30 Days Pre-surgery and 30 Days Post-surgery
Generalized Anxiety Disorder (GAD)-7
The GAD-7 is a screening tool used for assessing symptoms of generalized anxiety disorder. Scores range from 0-21 (7 items, 0 = not at all to 3 = nearly every day). Higher indicates greater anxiety severity.
Time frame: 30 Days Pre-surgery and 30 Days Post-surgery
Multidimensional Assessment of Interoceptive Awareness - Version 2 (MAIA-2)
MAIA-2 is designed as a tool to assess interoceptive awareness. It is made up of eight subscales including: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trust. Each subscale is totaled separately. Subscales are scored 0-5 (mean of items). Higher scores indicate greater interoceptive awareness.
Time frame: 30 Days Pre-surgery and 30 Days Post-surgery
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National University of Natural Medicine