Medium-/Long-segment Spinal Fusion PatientsEarly Phase 1NCT07766824
Evaluation of an Online Peri-operative Health Education Platform for Patients Undergoing Spine Surgery: Ready Set Recover
A Early Phase 1 study testing Ready Set Recover in people with Medium-/Long-segment Spinal Fusion Patients and Spine Surgeons, run by National University of Natural Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Medium-/Long-segment Spinal Fusion Patients, Spine Surgeons, Chronic Low Back Pain
- What is being tested?
- Ready Set Recover
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2026to 30 Sep 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97201
Dana Dharmakaya Colgan Assistant Professor, PhD, 15034947377, colgand@ohsu.edu
Ryan Wexler, ND, MSCR, 5034947377, rwexler@nunm.edu
About this study
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.
Read more
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.
- Conditions
- Medium-/Long-segment Spinal Fusion Patients, Spine Surgeons, Chronic Low Back Pain, Scoliosis Patients, Lumbar Spondylosis, Lumbar Spondylolisthesis
- Being tested
- Ready Set Recover
- Keywords
- back surgery, medium-/long-segment spinal fusion, mindfulness, Perioperative Care, Whole Person Care, Chronic low back pain, Feasibility, Qualitative
- Medical subject headings
- Spondylosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready Set RecoverBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery + Standard of Care | No intervention | Surgery + Standard of care is defined as instrumented spinal fusion with routine perioperative care, including preoperative information, postoperative mobilization, and standard analgesia. |
| Surgery+RSR | Experimental | 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. Receives: Behavioral: Ready Set Recover |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Retention
Measured using a participant tracking spreadsheet
Measured: 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.
Measured: Daily from baseline through end of intervention (30 days post surgery)
Feasibility of enrollment
Enrollment Rate: Measured using a participant tracking spreadsheet.
Measured: Data collected during screening and enrollment process
Feasibility of Adherence
Measured through completion with the RSR daily actions and educational materials.
Measured: 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.
Measured: 30- days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medium-/Long-segment Spinal Fusion PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mixed methods study involving a1:1 randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, READY SET RECOVER, LLC
- Responsible party
- Principal investigator, Dharma Colgan, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766824
- Sponsor's protocol ID
- Ready Set Recovery DC90325
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Online Peri-operative Health Education Platform for Patients Undergoing Spine Surgery: Ready Set Recover
- ClinicalTrials.gov ID
- NCT07766824
- Acronym / sponsor ID
- Ready Set Recovery DC90325
- Conditions
- Medium-/Long-segment Spinal Fusion Patients, Spine Surgeons, Chronic Low Back Pain, Scoliosis Patients, Lumbar Spondylosis, Lumbar Spondylolisthesis
- Keywords
- back surgery, medium-/long-segment spinal fusion, mindfulness, Perioperative Care, Whole Person Care, Chronic low back pain, Feasibility, Qualitative
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, READY SET RECOVER, LLC
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed methods study involving a1:1 randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Surgery + Standard of Care | No intervention | –Surgery + Standard of care is defined as instrumented spinal fusion with routine perioperative care, including preoperative information, postoperative mobilization, and standard analgesia. |
| Surgery+RSR | Experimental | Behavioral: Ready Set RecoverSpinal 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ready Set RecoverReady 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. | Behavioural | Surgery+RSR |
Primary outcome
Feasibility of Retention
Time frame: 30 days post-surgery
Measured using a participant tracking spreadsheet
Adverse Events (AEs)
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.
Feasibility of enrollment
Time frame: Data collected during screening and enrollment process
Enrollment Rate: Measured using a participant tracking spreadsheet.
Feasibility of Adherence
Time frame: 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
Time frame: 30- days post surgery
Measured through the qualitative study exit interview and the Client Satisfaction Questionnaire.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ready Set Recover in people with Medium-/Long-segment Spinal Fusion Patients and Spine Surgeons, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Wexler Assistant Research Investigator, ND, MSRC (15034947377, rwexler@nunm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Retention (time frame: 30 days post-surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.