MBM and taVNS for Low Back Pain and Depressive Symptoms

Florida State University

Status: Enrolling

Conditions: Chronic Low Back Pain

Treatments: Behavioral: MBM; Device: VNSM

Study type: Interventional

Funder types: Other

Identifiers

NCT07415941

STUDY00004314

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Mindfulness-based meditation (MBM)

Active Comparator group

Description:

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

Treatment:

Behavioral: MBM

back-to-back taVNS and MBM

Experimental group

Description:

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).

Treatment:

Device: VNSM