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Can meditation and a gentle ear zap ease back pain and depression?

NCT ID NCT07415941

Symptom relief Sponsor: Florida State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether combining mindfulness meditation with a mild nerve stimulation device (applied to the ear) can help older adults manage chronic low back pain and depressive symptoms. Participants will practice daily at home for 8 weeks. The goal is to see if this drug-free approach reduces pain intensity and improves mood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mindfulness meditation and transcutaneous auricular vagus nerve stimulation
What this could lead to
If it works, this could offer a safe, drug-free way to reduce pain and improve mood for older adults with chronic back pain.
What could go wrong
This is a small, early-stage trial with only 66 participants, so results may not apply to everyone. The treatments require daily commitment, and benefits may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Depression

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic low-back pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Florida State University

    RECRUITING

    Tallahassee, Florida, 32306, United States

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