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 range18 Years – 80 Years
SexALL
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
✕. current daily opioid use greater than 100mg morphine equivalents
✕. unable to receive acupuncture due to injury, infection, or other contraindication to the use of needles at acupuncture sites
✕. not possible to attend outpatient clinic for AA follow-up (e.g., from out-of-state)