SpinePal Open Pilot (NCT07737912) | Clinical Trial Compass
By InvitationNot Applicable
SpinePal Open Pilot
United States10 participantsStarted 2026-08-01
Plain-language summary
SpinePal is a self-guided digital intervention developed for patients undergoing spine surgery. The goal of this study is to learn if SpinePal is acceptable to people undergoing spine surgery. The main questions the investigators aim to answer are:
* Is the SpinePal platform considered usable and acceptable by people undergoing spine surgery?
* Is the SpinePal intervention feasible among people undergoing spine surgery?
Participants will:
* Take a screening questionnaire
* Engage with SpinePal for about 2 weeks before surgery and 4 weeks after surgery
* Wear a smartwatch
* Complete questionnaires about 4 weeks after surgery
* Complete a brief virtual interview to share feedback with the study team
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years or older
* English-speaking
* Able and willing to provide informed consent
* Scheduled for lumbar or cervical fusion surgery at least 2 weeks from the date of enrollment
* Owns a smartphone with reliable internet and/or data access
* Willing to engage with SpinePal and physiological monitoring via wrist-worn Garmin
Exclusion Criteria:
* Undergoing surgery for infection, malignancy, or trauma
* Undergoing isolated thoracic fusion
* Undergoing another major surgery within 3 months
* Active suicidal ideation and/or severe mental illness (e.g., psychosis)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Usability
Timeframe: Enrollment to the end of treatment at 1 month post-surgery
2
Acceptability
Timeframe: Enrollment to the end of treatment at 1 month post-surgery