MBM and taVNS for Low Back Pain and Depressive Symptoms

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT07415941
Status
Recruiting
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Conditions

  • Chronic Low Back Pain

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • MBM — BEHAVIORAL
    MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.
  • VNSM — DEVICE
    The VNSM consists of a single daily session, five days per week, comprising 20 minutes of taVNS immediately followed by 20 minutes of MBM (total ≈ 40 minutes) for 8 weeks.

Study Details

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.

Key Dates

Start date
Jan 30, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Mindfulness-based meditation (MBM)
    MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.
  • Experimental: back-to-back taVNS and MBM
    The VNSM includes a single daily session, five days per week, consisting of back-to-back 20-minute taVNS immediately followed by 20-minute MBM (total ≈ 40 minutes).

Primary Outcome Measure

Change in pain intensity and interference [ Time Frame: Baseline and 2 weeks and 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida State UniversityTallahasseeFlorida32306
Jie Chen
[email protected]
8506450657

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Florida State University· Tallahassee, FL

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