MBM and taVNS for Low Back Pain and Depressive Symptoms

NCT07415941 | Recruiting FDA Device

• 1 other identifier: STUDY00004314
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low Back Pain

Keywords

depressive symptoms; older adults; mindfulness; taVNS

Outcome Measures

Primary Outcomes (2)

• Change in pain intensity and interference

  The pain intensity and interference will be measured by the brief pain inventory (BPI) and the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) adults short form pain interference 8a measurement. There are 15 items in BPI with 4 items in pain intensity (worst, least, average, right now) and 7 items in pain interference (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life).

  Baseline and 2 weeks and 8 weeks

• Change in depressive symptoms

  The patient health questionnaire (PHQ-9) will be used to measure depressive symptoms. The PHQ-9 is scored on a scale of 0 to 27, with higher scores indicating greater severity of depressive symptoms. A score of 5 to 9 indicates mild depression, 10 to 14 indicates moderate depression, 15 to 19 indicates moderately severe depression, and 20 or above indicates severe depression.

  Baseline and 2 weeks and 8 weeks

Secondary Outcomes (6)

• Quantitative sensory testing (QST)

  Baseline and 2 weeks and 8 weeks

• Conditioned pain modulation (CPM)

  Baseline and 2 weeks and 8 weeks

• Change in chronic pain self-efficacy

  Baseline and 2 weeks and 8 weeks

• Changes in co-occurring symptoms

  Baseline and 2 weeks and 8 weeks

• Changes in pain-related cortical response

  Baseline and 2 weeks and 8 weeks

Study Arms (2)

Mindfulness-based meditation (MBM)

ACTIVE COMPARATOR

MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.

Behavioral: MBM

back-to-back taVNS and MBM

EXPERIMENTAL

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).

Device: VNSM

Interventions

MBM BEHAVIORAL

MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.

Mindfulness-based meditation (MBM)

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.

back-to-back taVNS and MBM

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 50 to 85 years old
• intact cognition (examined by the Mini-Mental State Exam, ≥ 24)
• experiencing moderate low back pain daily or almost every day at least the previous three months (≥3 out of 10 on numeric rating scale \[NRS\])
• experiencing elevated depressive symptoms with the patient health questionnaire (PHQ-9) total score ranging between 5 to 19
• able to speak and read English
• not intent to change medication regimens for pain throughout the trial.

You may not qualify if:

• serious underlying illness (e.g., malignant neoplasms),
• other psychosis,
• elevated suicide risk as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) score \> 2,
• function limitation precluded the meditation practice,
• participated meditation program before,
• any other conditions/contraindications that prohibit the application of taVNS including but not limited to any current or past history of cardiovascular disorders, recent ear trauma, and metal implants above the level of the neck,
• no access to the internet.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Jie Chen

CONTACT

18506450657; jc22db@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)