Trials
Search / Trial NCT06429072

Integration of Mindfulness and Acupuncture After Spine Surgery

Launched by DUKE UNIVERSITY · May 20, 2024

Trial Information

Current as of February 19, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

Participants will be randomized to one of two study arms: 1) the I-MASS program plus enhanced education or 2) the enhanced education intervention only.

I-MASS program plus enhanced education (Intervention) Arm: This arm begins with one introductory telephone call by a mindfulness coach within 1 week of the patient scheduling surgery to introduce the participant to the Pattern Health app, discuss the benefits of combining mindfulness and acupuncture, discuss how to access the Healthwise educational content, and lead a brief (\~10 min) mindfulness exercise, as desired. Thereafter, participan...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. undergoing single level fusion, discectomy or laminectomy of the cervical or lumbar spine for management of pain
  • 2. 18 years of age or older
  • 3. has access to a smartphone or mobile device (with android or iOS operating system) and internet to complete training and questionnaires.
  • Exclusion Criteria:
  • 1. 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)
  • 2. undergoing surgery for neoplastic disease
  • 3. current daily opioid use greater than 100mg morphine equivalents
  • 4. unable to receive acupuncture due to injury, infection, or other contraindication to the use of needles at acupuncture sites
  • 5. not possible to attend outpatient clinic for AA follow-up (e.g., from out-of-state)
  • 6. currently practicing mindfulness or receiving acupuncture
  • 7. in Hospice, receiving palliative care.

Trial Officials

Trevor Lentz, PhD

Principal Investigator

Duke University

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0