I-MASS Aim 2 - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental pain management regimen called I-MASS is an effective practice to help people who have spine surgery recover and have less pain. I-MASS stands for Integration of mHealth Mindfulness and Auricular Acupuncture for Individuals Undergoing Spine Surgery. The I-MASS program combines the integrative health practices of mindfulness and acupuncture.

What is the Condition Being Studied?

Recovery from Surgery to the Spine (Neck or Lower Back)

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are scheduled to have one of the following procedures: a single level fusion, discectomy, or laminectomy of the cervical (neck) or lumbar (low back) spine for pain relief
  • Are not currently practicing mindfulness or getting acupuncture
  • Have access to a smartphone or mobile device

For more information, contact the study team at mary-margaret.remchak@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:

  • You might be assigned to participate in the I-MASS regimen and receive educational materials about post-surgery recovery; OR
  • You might be assigned to receive only educational materials about post-surgery recovery

You can fill out an interest survey for this study online: https://redcap.duke.edu/redcap/surveys/?s=JJHWRRRYMPPWHLP9

Study Details

Full Title
Integration of Mindfulness and Acupuncture after Spine Surgery
Principal Investigator
Trevor Lentz
Protocol Number
IRB: PRO00114814
NCT: NCT06429072
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment