Integration of Mindfulness and Acupuncture After Spine Surgery
Completed · Not applicable
Conditions studied: Single Level Spinal Fusion, Discetomy, Laminectomy
In brief
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.
Key facts
- Study ID
- NCT06429072
- Run by
- Duke University
- People needed
- 50
- Starts
- 2024-08-15
- Expected to finish
- 2025-10-15
- Last updated by the study team
- 2025-11-19
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
- currently practicing mindfulness or receiving acupuncture
- in Hospice, receiving palliative care.
Where it is running
- Duke Sports Science Institute — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.