---
title: MBM and taVNS for Low Back Pain and Depressive Symptoms
nct_id: NCT07415941
overall_status: RECRUITING
phase: NA
sponsor: Florida State University
study_type: INTERVENTIONAL
primary_condition: Chronic Low Back Pain
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07415941.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07415941"
ct_last_update_post_date: 2026-03-25
last_seen_at: "2026-05-12T07:06:45.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# MBM and taVNS for Low Back Pain and Depressive Symptoms

**Official Title:** Home-based Mindfulness-based Meditation and Transcutaneous Auricular Vagus Nerve Stimulation for Older Adults With Low Back Pain and Depressive Symptoms

**NCT ID:** [NCT07415941](https://clinicaltrials.gov/study/NCT07415941)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 66
- **Lead Sponsor:** Florida State University
- **Conditions:** Chronic Low Back Pain
- **Start Date:** 2026-01-30
- **Completion Date:** 2027-12-31
- **CT.gov Last Update:** 2026-03-25

## 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.

## Detailed Description

Primary Objective: To test the preliminary effect of home-based mindfulness-based meditation (MBM) and transcutaneous auricular vagus nerve stimulation (taVNS) on managing pain and depressive symptoms among community-dwelling older adults with chronic low back pain and depressive symptoms.

Secondary Objective(s): To test the effect of home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation on the host Brain-Gut Axis.

## Eligibility

- **Minimum age:** 50 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

Exclusion Criteria:

1. serious underlying illness (e.g., malignant neoplasms),
2. other psychosis,
3. elevated suicide risk as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) score \> 2,
4. function limitation precluded the meditation practice,
5. participated meditation program before,
6. 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,
7. no access to the internet.
```

## Arms

- **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.
- **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).

## 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.

## Primary Outcomes

- **Change in pain intensity and interference** _(time frame: Baseline and 2 weeks and 8 weeks)_ — 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).
- **Change in depressive symptoms** _(time frame: Baseline and 2 weeks and 8 weeks)_ — 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.

## Secondary Outcomes

- **Quantitative sensory testing (QST)** _(time frame: Baseline and 2 weeks and 8 weeks)_
- **Conditioned pain modulation (CPM)** _(time frame: Baseline and 2 weeks and 8 weeks)_
- **Change in chronic pain self-efficacy** _(time frame: Baseline and 2 weeks and 8 weeks)_
- **Changes in co-occurring symptoms** _(time frame: Baseline and 2 weeks and 8 weeks)_
- **Changes in pain-related cortical response** _(time frame: Baseline and 2 weeks and 8 weeks)_
- **Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut** _(time frame: Baseline and 2 weeks and 8 weeks)_

## Locations (1)

- Florida State University, Tallahassee, Florida, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.florida state university|tallahassee|florida|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07415941.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07415941*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*