Integration of Mindfulness and Acupuncture After Spine Surgery (NCT06429072) | Clinical Trial Compass
CompletedNot Applicable
Integration of Mindfulness and Acupuncture After Spine Surgery
United States50 participantsStarted 2024-08-15
Plain-language summary
The Integration of Mindfulness and Acupuncture for individuals undergoing Spine Surgery (I-MASS) is a novel combination of integrative treatments to improve post-surgical recovery.
This is a single-site, two-arm randomized feasibility and acceptability pilot trial of the I-MASS program plus enhanced patient education compared to enhanced patient education alone in patients undergoing spine surgery. Outcomes data will come from a combination of passive electronic health record data augmented with patient-reported data collected through the Pattern Health app (the mHealth platform used for delivering mindfulness training and collecting data). Outcomes will focus on feasibility and acceptability of I-MASS, feasibility of recruitment and retention strategies, and data collection procedures through both the Pattern Health app and electronic health record. Feasibility will be supported by mindfulness module completion rates, acupuncture visits attended, participant retention, and questionnaire completion rates. Acceptability will be supported by patient-reported satisfaction, acceptability and usability thresholds.
Who can participate
Age range
18 Years – 80 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
. undergoing single level fusion, discectomy or laminectomy of the cervical or lumbar spine for management of pain
. 18 years of age or older
. has access to a smartphone or mobile device (with android or iOS operating system) and internet to complete training and questionnaires.
Exclusion criteria
. have conditions making consent, follow-up data collection and/or use of the intervention prohibitive (e.g., Non-English speaking, serious psychiatric conditions \[i.e., schizophrenia\], traumatic brain injury, or dementia-type illness)
. undergoing surgery for neoplastic disease
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.