MBM and taVNS for Low Back Pain and Depressive Symptoms
ConditionChronic Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorFlorida State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged 50 to 85 years old
intact cognition (examined by the Mini-Mental State Exam, ≥ 24)
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])
experiencing elevated depressive symptoms with the patient health questionnaire (PHQ-9) total score ranging between 5 to 19
Disqualifiers
serious underlying illness (e.g., malignant neoplasms),
other psychosis,
elevated suicide risk as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) score > 2,
function limitation precluded the meditation practice,
Trial design
Design model
Parallel
Treatments tested in this trial
MBM
BehavioralMBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.
VNSM
DeviceThe 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Mindfulness-based meditation (MBM)Active comparator 1 intervention
Group B: back-to-back taVNS and MBMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in pain intensity and interference
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 weeks2
Change in depressive symptoms
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 weeksSecondary outcomes
1
Quantitative sensory testing (QST)
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 weeks2
Conditioned pain modulation (CPM)
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 weeks3
Change in chronic pain self-efficacy
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 weeks4
Changes in co-occurring symptoms
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 weeksSponsors and contacts
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Source ClinicalTrials.gov