Mindfulness + Vagus Nerve Stimulation for Chronic Lower Back Pain and Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments for chronic lower back pain and depression. One treatment involves mindfulness-based meditation (MBM) for 20 minutes daily, while the other combines MBM with vagus nerve stimulation (taVNS), which uses a gentle electrical current applied to the ear. The researchers aim to determine if these treatments can improve pain and mood by influencing the brain-gut connection. The trial seeks participants aged 50 to 85 who have experienced moderate back pain nearly every day for at least three months and show symptoms of depression. As an unphased trial, it offers a unique opportunity to explore innovative treatments for pain and mood improvement.
Do I have to stop taking my current medications for the trial?
The trial requires that you do not change your current medication regimen for pain throughout the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found mindfulness-based meditation (MBM) safe and well-tolerated for people with chronic low back pain. Various studies highlight its excellent safety profile and effectiveness in managing pain. Participants typically complete an 8-week program without significant issues.
Research shows that transcutaneous auricular vagus nerve stimulation (taVNS) is also safe and practical. A review of studies found that taVNS has a good safety record in clinical settings and has shown promise in alleviating both pain and symptoms of depression.
Overall, past studies have tested both treatments with positive safety results, making them promising options for managing chronic pain and depression.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer a fresh approach to managing chronic lower back pain and depression. Unlike typical treatments like medication or physical therapy, this trial combines mindfulness-based meditation (MBM) with transcutaneous auricular vagus nerve stimulation (taVNS), a novel method that uses gentle electrical impulses to stimulate a key nerve in the body. This combination aims to not only alleviate pain but also improve mood and mental well-being. By integrating these two techniques, there's potential for a holistic treatment that addresses both physical and emotional aspects of these conditions, which could be a game-changer for patients.
What evidence suggests that this trial's treatments could be effective for chronic lower back pain and depression?
Research has shown that mindfulness-based meditation (MBM), which participants in this trial may receive, effectively reduces pain and improves the quality of life for people with chronic low back pain. A review of studies found significant improvements in pain levels and physical ability. Mindfulness meditation offers both short-term relief and long-term benefits for managing back pain.
For transcutaneous auricular vagus nerve stimulation (taVNS), another treatment option in this trial, research suggests it can lower pain levels in chronic pain conditions. It also shows promise for reducing symptoms of depression, with studies indicating better outcomes in self-reported depression scores. Together, these treatments address both the physical and emotional aspects of chronic pain and depression.13567Are You a Good Fit for This Trial?
This trial is for adults aged 50–85 who have had moderate daily low back pain and mild to moderate depression for at least three months, can think clearly, speak and read English, and do not plan to change their pain medications during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation for managing pain and depressive symptoms
Follow-up
Participants are monitored for changes in pain intensity, depressive symptoms, and other secondary outcomes
What Are the Treatments Tested in This Trial?
Interventions
- MBM
- taVNS
Trial Overview
The study compares two home-based treatments: mindfulness meditation (MBM) and a device that stimulates the ear's vagus nerve (taVNS), to see how they affect pain, mood, and brain-gut health in older adults with chronic low back pain and depressive symptoms.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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).
MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Florida State University
Lead Sponsor
Citations
Effectiveness of mindfulness meditation on pain and quality of ...
MBSR as a mind-body therapy including body scan, sitting and walking meditation was effective intervention on reduction of pain severity.
Mindfulness-based Interventions for Chronic Low Back Pain
This systematic review aimed to compile existing evidence examining the effects of mindfulness-based interventions (MBIs) for chronic low back pain (CLBP).
3.
kpwashingtonresearch.org
kpwashingtonresearch.org/index.php/news-and-events/recent-news/news-2016/mindfulness-meditation-eases-chronic-low-back-painMindfulness meditation eases chronic low back pain
JAMA publishes research by Group Health researchers, comparing mindfulness, cognitive behavioral therapy, and usual care for back pain.
Effectiveness of mindfulness meditation on the quality of life ...
Effectiveness of mindfulness meditation on the quality of life, pain intensity, mobility and physical function in adults with chronic low back ...
5.
pure.psu.edu
pure.psu.edu/en/publications/mindfulness-based-interventions-for-chronic-low-back-pain-a-syste/Mindfulness-based Interventions for Chronic Low Back ...
The meta-analysis revealed that MBIs have a beneficial effect on pain intensity with a large-sized effect in adults with CLBP. Conclusions: MBIs ...
Mindfulness Meditation for Chronic Low Back Pain - Whole ...
Mindfulness Meditation-Based Intervention Is Feasible, Acceptable, and Safe for Chronic Low Back Pain Requiring Long-Term Daily Opioid Therapy. J Altern ...
Mindfulness meditation for the treatment of chronic low back ...
An 8-week mindfulness-based meditation program is feasible for older adults with CLBP. The program may lead to improvement in pain acceptance and physical ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.