66 Participants NeededMy employer runs this trial

Mindfulness + Vagus Nerve Stimulation for Chronic Lower Back Pain and Depression

JC
Overseen ByJie Chen
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Florida State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This two-arm randomized controlled trial aims to test the preliminary effect of home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation on managing pain and depressive symptoms among community-dwelling older adults with chronic low back pain and depressive symptoms; and the effect of home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation on the host Brain-Gut Axis.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 50 and 85 years old.
2. intact cognition (examined by the Mini-Mental State Exam, ≥ 24)
I have had moderate low back pain almost every day for at least three months.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation for managing pain and depressive symptoms

8 weeks
Daily sessions, 5 days per week

Follow-up

Participants are monitored for changes in pain intensity, depressive symptoms, and other secondary outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MBM
  • taVNS

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: back-to-back taVNS and MBMExperimental Treatment1 Intervention
Group II: Mindfulness-based meditation (MBM)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials
234
Recruited
41,100+