Chronic Low Back Pain
Conditions
Keywords
depressive symptoms, older adults, mindfulness, taVNS
Brief summary
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
BEHAVIORALMBM
MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.
DEVICEVNSM
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.
Sponsors
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity and interference | 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). |
| Change in depressive symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative sensory testing (QST) | 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. |
| Conditioned pain modulation (CPM) | 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. |
| Change in chronic pain self-efficacy | 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 |
| Changes in co-occurring symptoms | 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. |
| Changes in pain-related cortical response | 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. |
| Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut | 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. |
Countries
United States
Contacts
CONTACTJie Chen
Outcome results
None listed