Study of MBM and taVNS for Chronic Low Back Pain and Depressive Symptoms
This study is testing two approaches for managing chronic low back pain and depressive symptoms in older adults: mindfulness-based meditation (MBM) and transcutaneous auricular vagus nerve stimulation (taVNS). MBM involves daily meditation sessions, while VNSM combines daily taVNS (a device that stimulates a nerve in the ear) with MBM. The study aims to see how well these interventions reduce pain and depressive symptoms. You might be able to join if you are 50 to 85 years old, have chronic low back pain, and are experiencing elevated depressive symptoms. The study is looking for 66 participants and its current status is unclear.
- Study design
- This is a randomized controlled trial with 66 planned participants. It compares two different approaches for 8 weeks.
- What's involved
- Participants will engage in daily sessions, five days a week, for 8 weeks. This involves either 20 minutes of MBM or 40 minutes combining taVNS and MBM.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pain intensity, interference, and depressive symptoms will be measured at 2 weeks and 8 weeks after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
MBM and taVNS for Low Back Pain and Depressive Symptoms
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Change in pain intensity and interferenceBaseline 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 symptomsBaseline 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.