Chronic Lower Back PainNCT06619418
Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain
A study testing TENS device and Integrative health modalities in people with Chronic Lower Back Pain, run by University of Minnesota at 1 site in United States.
Trial summary
Pain symptoms can have a variety of ways to be treated, from medications to physical therapy, with several options being available to patients. However, no one treatment may work for all people who experience pain, especially cLBP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lower Back Pain
- What is being tested?
- TENS device and Integrative health modalities
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 11 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 years of age or older
- Must be within commuting distance to the University of Minnesota
- Able to provide consent and follow study instructions
- Must be able to understand English
- Must have chronic LBP, which is defined as lower back pain for more than 3 months
- A score of 4 or higher on the PEG
- Must be willing to commit to full duration of the study
- Not currently taking any benzodiazepines or sedative hypnotics
Who cannot join
- Back Pain associated with:
- Spondylolisthesis or spinal stenosis
- Sciatica or radiculopathy
- Rhematologic or inflammatory disease
- Trauma, fracture, dislocation, or previous back surgery
- A score of 10 on the PEG
Show all 14Show fewer
- Pregnant
- Have an electrically implanted device, such as a pacemaker.
- Heart Disease
- Epilepsy
- Cancer
- Psychiatric conditions including psychosis, suicidal ideation, or substance abuse disorder
- A pure tone average of more than 40 dB HL at 500 dB, 1000 dB, or 2000 dB HL.
- Individuals currently using other lower back pain treatments during the study in which they are unable to maintain a steady state while participating in our study for one month before beginning the multi-modal regimen.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Grace Conchas contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Grace Conchas, bunchh123@umn.edu
About this study
Pain symptoms can have a variety of ways to be treated, from medications to physical therapy, with several options being available to patients. However, no one treatment may work for all people who experience pain, especially cLBP. The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP). The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. In isolation, these treatments are only somewhat effective in reducing symptoms.
This pilot study will involve participants who experience cLBP as we investigate a novel at-home, multi-modal device design. The main objective of the pilot usability study is to examine compliance to the intended use of the multi-modal device and approach, as well as protocol feasibility, and satisfaction with the settings and design.
- Conditions
- Chronic Lower Back Pain
- Being tested
- TENS device, Integrative health modalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS deviceDevice
will be using an FDA- cleared TENS device for electrical stimulation (TENS 7000, Compass Health Brands) in combination with commercially-available headphones for acoustic stimulation (AKG 845 BT).Will be shown how to use the device, trained on the multimodal stimulation procedure, and sent home with the device for 12 weeks.
Integrative health modalitiesBehavioural
will be instructed on the integrative health modalities for this study. They will be given a tablet that includes the videos for the visually guided deep breathing. They will also receive the reflective journal and be set up for health coaching visits. At the end of the 12 weeks, this group of participants will return to the U of M campus and complete an interview about satisfaction and usability of the IH modalities.
| Study group | Role | What they receive |
|---|---|---|
| device group | Experimental | Not described Receives: Device: TENS device |
| Integrative health modality group | Active comparator | Not described Receives: Behavioral: Integrative health modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance rate
Measure compliance in terms of time using the integrative health devices and the multi-modal stimulation device over a period of 12 weeks to determine the effect on participant compliance by adding electrical stimulation to the device.
Measured: 12 weeks
Secondary outcomes (1)
satisfaction rate
relating to usability of an at-home multi-modal stimulation approach and device and integrative health practices..
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start18 Nov 2024
- Primary completion11 Aug 2027 (estimated)
- Study completion11 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lower Back PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Molly Sturges, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619418
- Sponsor's protocol ID
- ENT-2024-33112
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain
- ClinicalTrials.gov ID
- NCT06619418
- Acronym / sponsor ID
- ENT-2024-33112
- Conditions
- Chronic Lower Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 11 Aug 2027 (estimated)
- Study completion
- 11 Aug 2027 (estimated)
- First posted
- 1 Oct 2024 (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.
Pain symptoms can have a variety of ways to be treated, from medications to physical therapy, with several options being available to patients. However, no one treatment may work for all people who experience pain, especially cLBP. The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP). The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. In isolation, these treatments are only somewhat effective in reducing symptoms.
This pilot study will involve participants who experience cLBP as we investigate a novel at-home, multi-modal device design. The main objective of the pilot usability study is to examine compliance to the intended use of the multi-modal device and approach, as well as protocol feasibility, and satisfaction with the settings and design.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| device group | Experimental | Device: TENS device |
| Integrative health modality group | Active comparator | Behavioral: Integrative health modalities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be 18 years of age or older
- Must be within commuting distance to the University of Minnesota
- Able to provide consent and follow study instructions
- Must be able to understand English
- Must have chronic LBP, which is defined as lower back pain for more than 3 months
Key exclusion criteria (14 listed)
- Back Pain associated with:
- Spondylolisthesis or spinal stenosis
- Sciatica or radiculopathy
- Rhematologic or inflammatory disease
- Trauma, fracture, dislocation, or previous back surgery
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 |
|---|---|---|
| TENS devicewill be using an FDA- cleared TENS device for electrical stimulation (TENS 7000, Compass Health Brands) in combination with commercially-available headphones for acoustic stimulation (AKG 845 BT).Will be shown how to use the device, trained on the multimodal stimulation procedure, and sent home with the device for 12 weeks. | Device | device group |
| Integrative health modalitieswill be instructed on the integrative health modalities for this study. They will be given a tablet that includes the videos for the visually guided deep breathing. They will also receive the reflective journal and be set up for health coaching visits. At the end of the 12 weeks, this group of participants will return to the U of M campus and complete an interview about satisfaction and usability of the IH modalities. | Behavioural | Integrative health modality group |
Primary outcome
compliance rate
Time frame: 12 weeks
Measure compliance in terms of time using the integrative health devices and the multi-modal stimulation device over a period of 12 weeks to determine the effect on participant compliance by adding electrical stimulation to the device.
1 secondary outcome
satisfaction rate
Time frame: 12 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 20 Aug 2026.
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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.
Grace Conchas contact
Molly Sturges principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS device and Integrative health modalities in people with Chronic Lower Back Pain, run by University of Minnesota 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 8 inclusion and 14 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 20 Aug 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 Grace Conchas (buchh123@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compliance rate (time frame: 12 weeks). 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 20 Aug 2026.