Chronic Low Back PainNCT07415941
MBM and taVNS for Low Back Pain and Depressive Symptoms
A study testing MBM and VNSM in people with Chronic Low Back Pain, run by Florida State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- MBM and VNSM
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- able to speak and read English
- not intent to change medication regimens for pain throughout the trial.
Who cannot join
- 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,
- participated meditation program before,
- 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,
- no access to the internet.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida State University
Tallahassee, Florida, 32306
Jie Chen, 8506450657, jc22db@fsu.edu
About this study
Official title: Home-based Mindfulness-based Meditation and Transcutaneous Auricular Vagus Nerve Stimulation for Older Adults With Low Back Pain and Depressive Symptoms
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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- MBM, VNSM
- Keywords
- depressive symptoms, older adults, mindfulness, taVNS
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBMBehavioural
MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks.
VNSMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based meditation (MBM) | Active comparator | MBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks. Receives: Behavioral: MBM |
| back-to-back taVNS and MBM | Experimental | 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). Receives: Device: VNSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 2 weeks and 8 weeks
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.
Measured: Baseline and 2 weeks and 8 weeks
Secondary outcomes (6)
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.
Measured: Baseline and 2 weeks and 8 weeks
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.
Measured: Baseline and 2 weeks and 8 weeks
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
Measured: Baseline and 2 weeks and 8 weeks
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.
Measured: Baseline and 2 weeks and 8 weeks
Changes in pain-related cortical response
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.
Measured: Baseline and 2 weeks and 8 weeks
Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut
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.
Measured: Baseline and 2 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start30 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Chen, PhD, RN, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415941
- Sponsor's protocol ID
- STUDY00004314
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Deidentified data will be available upon reasonable request. Requests to access these datasets should be directed to jc22db@fsu.edu.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Mindfulness-based Meditation and Transcutaneous Auricular Vagus Nerve Stimulation for Older Adults With Low Back Pain and Depressive Symptoms
- ClinicalTrials.gov ID
- NCT07415941
- Acronym / sponsor ID
- STUDY00004314
- Conditions
- Chronic Low Back Pain
- Keywords
- depressive symptoms, older adults, mindfulness, taVNS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based meditation (MBM) | Active comparator | Behavioral: MBMMBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks. |
| back-to-back taVNS and MBM | Experimental | Device: VNSMThe 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). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- able to speak and read English
Key exclusion criteria (7 listed)
- 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,
- participated meditation program before,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBMMBM is designed to be applied for 20 minutes per session daily, five days per week, for 8 weeks. | Behavioural | Mindfulness-based meditation (MBM) |
| VNSMThe 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. | Device | back-to-back taVNS and MBM |
Primary outcome
Change in pain intensity and interference
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).
Change in depressive symptoms
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.
6 secondary outcomes
Quantitative sensory testing (QST)
Time frame: Baseline and 2 weeks and 8 weeks
Conditioned pain modulation (CPM)
Time frame: Baseline and 2 weeks and 8 weeks
Change in chronic pain self-efficacy
Time frame: Baseline and 2 weeks and 8 weeks
Changes in co-occurring symptoms
Time frame: Baseline and 2 weeks and 8 weeks
Changes in pain-related cortical response
Time frame: Baseline and 2 weeks and 8 weeks
Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut
Time frame: Baseline and 2 weeks and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No. Deidentified data will be available upon reasonable request. Requests to access these datasets should be directed to jc22db@fsu.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBM and VNSM in people with Chronic Low Back Pain, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Chen (18506450657, jc22db@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity and interference (time frame: Baseline and 2 weeks and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.