Integration of Mindfulness and Acupuncture After Spine Surgery: Protocol for a Randomized Acceptability and Feasibility Trial.

Background: Spine surgery is increasingly common in the United States, contributing substantially to spine-related health care costs. While many patients benefit, up to 25% experience chronic postsurgical pain, and the procedure is linked to high rates of opioid misuse. Key risk factors for persistent pain and opioid use include poorly controlled early postsurgical pain, high pain-sensitivity, and poor pain-coping. Clinical guidelines recommend multimodal treatment to address these risks, but such approaches are not well studied or widely implemented. Combining two safe and effective nonpharmacologic treatments, specifically mindfulness and acupuncture that target these factors, has the potential to improve postsurgical recovery and reduce the incidence of chronic pain and opioid use. Objective: This paper describes the study protocol for the Integrating Mindfulness and Acupuncture after Spine Surgery (I-MASS), which is a single-site, 2-arm randomized controlled trial that will assess the feasibility and acceptability of a novel multicomponent program integrating mindfulness delivered via a mobile app, acupuncture, and education for patients undergoing single-level spine surgery. Methods: A total of 50 participants will be randomized 1:1 to receive (1) mindfulness and acupuncture (ie, I-MASS program) plus enhanced education or (2) enhanced education alone. Mindfulness training will consist of a 4-week app-based program starting 1 week prior to surgery, and acupuncture will include up to 8 visits (1 visit prior to surgery and 7 after surgery) during the 13-week program. Enhanced education appropriate for each phase of recovery will be delivered through the mobile app. Primary outcomes are recruitment eligibility and enrollment rates, mindfulness module and acupuncture visit completion rates, questionnaire completion rates, and participant satisfaction. Secondary outcomes include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, sleep disturbance, fear avoidance beliefs, pain intensity, pain medication use, adverse events, hospital readmissions, and emergency department visits. Results: Trial enrollment began in August 2024. As of May 9, 2025, 35 participants have been enrolled. Data analysis has not yet been performed. Enrollment is expected to be completed in the fall of 2025. Conclusions: The I-MASS program addresses the need for mind and body treatments to improve recovery and reduce the risk of persistent pain and opioid use after spine surgery. This integrated model of care is designed to be user-friendly and scalable, enhancing its potential for implementation in real-world settings. A future pragmatic trial is planned to determine if the I-MASS program results in better outcomes compared to either treatment alone or usual care.