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Recruiting NCT07415941

MBM and taVNS for Low Back Pain and Depressive Symptoms

No phase Interventional Chronic Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MBM, VNSM.
Who it may be relevant to
Registry conditions: Chronic Low Back Pain. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral MBM
    MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.
  • Device VNSM
    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 outcome measures

  • Change in pain intensity and interference [Time frame: Baseline and 2 weeks and 8 weeks]
  • Change in depressive symptoms [Time frame: Baseline and 2 weeks and 8 weeks]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Florida State University — Tallahassee

Identifiers

NCT: NCT07415941 · STUDY00004314

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗