Oregon Health & Science University
Portland, Oregon, 97201, United States
Location contact
Dana Dharmakaya Colgan Assistant Professor, PhD
CONTACT
Ryan Wexler, ND, MSCR
CONTACT
NCT Number: NCT07766824
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Early Phase 1
Portland, Oregon, 97201, United States
Dana Dharmakaya Colgan Assistant Professor, PhD
CONTACT
Ryan Wexler, ND, MSCR
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 30 days post-surgery
Measured using a participant tracking spreadsheet
Time frame: 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.
Time frame: Data collected during screening and enrollment process
Enrollment Rate: Measured using a participant tracking spreadsheet.
Time frame: Daily from baseline through end of intervention (30 days post surgery)
Measured through completion with the RSR daily actions and educational materials.
Time frame: 30- days post surgery
Measured through the qualitative study exit interview and the Client Satisfaction Questionnaire.
Time frame: Daily from baseline through end of intervention (30 days post surgery)
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: 30 Days Pre-surgery and 30 Days Post-surgery
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
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
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
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
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
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
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
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
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
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
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
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.
Contact information is provided by the study sponsor or research team.
Dana Dharmakaya Colgan Assistant Professor, PhD
CONTACT
Ryan Wexler Assistant Research Investigator, ND, MSRC
CONTACT
National University of Natural Medicine
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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