Florida State University
Tallahassee, Florida, 32306, United States
Location status: Recruiting
NCT Number: NCT07415941
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.
Interested in participating?
Request Info50 year–85 year
All sexes
Interventional
Not applicable
Tallahassee, Florida, 32306, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.
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.
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).
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.
Time frame: Baseline and 2 weeks and 8 weeks
QST will be used to measure sensitivity to experimental pain with standardized stimuli to test both nociceptive and non-nociceptive systems following our previous protocol. QST consists of 7 tests measuring 13 parameters to assess and quantify the perception of temperature, touch, pain, vibration, and pressure.
Time frame: Baseline and 2 weeks and 8 weeks
CPM will be used to determine the net effect of various facilitating and inhibiting systems exerting their activity at spinal or supraspinal levels. A phasic noxious stimulus (cold) will be applied in conjunction with a tonic noxious conditioning stimulus (pressure) applied to a distant body site on the forearm. Participants' self-reported pain intensity by NRS during the test will be recorded.
Time frame: Baseline and 2 weeks and 8 weeks
Chronic Pain Self-Efficacy Scale (CPSES) will be used to measure pain self-efficacy with scores from 0-100, higher scores indicating improved self-efficacy.
Time Frame: Baseline and 2 weeks and 8 weeks
Time frame: Baseline and 2 weeks and 8 weeks
The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the co-occurring symptoms, including anxiety, physical function, fatigue, and sleep disturbance. The response scores of each item will be summed for the total raw score; the raw scores will then be transferred to the standardized T-score with a mean of 50 and a standard deviation of 10 for the general population in the USA. The T-scores of PROMIS measures will be calculated following the NIH instruction, ranging from 0 to 100.
Time frame: Baseline and 2 weeks and 8 weeks
Cortical activity associated with pain stimuli will be assessed utilizing a continuous-wave, multichannel functional near-infrared spectroscopy (fNIRS) imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) equipped with three semiconductor lasers emitting at 780, 805, and 830 nm. Optical data will be gathered while subjects undergo thermal pain stimulation.
Time frame: Baseline and 2 weeks and 8 weeks
The 16S rRNA V4 region will be amplified and sequenced by using stool samples to depict the fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut.
Contact information is provided by the study sponsor or research team.
Florida State University
Other
Home-based Mindfulness-based Meditation and Transcutaneous Auricular Vagus Nerve Stimulation for Older Adults With Low Back Pain and Depressive Symptoms
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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