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TENS Device and Integrative Health Techniques for Back Pain

N/A
Recruiting
Led By Molly Sturges
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have chronic LBP, which is defined as lower back pain for more than 3 months
Must be 18 years of age or older
Must not have
Back Pain associated with sciatica or radiculopathy
Back Pain associated with rheumatologic or inflammatory disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new at-home device that combines electrical and auditory stimulation with integrative health techniques like mindfulness and journaling for people with chronic lower back pain. The study will look at how

Who is the study for?
This trial is for a diverse group of people who have chronic lower back pain (cLBP). Participants should be willing to use an at-home multi-modal stimulation device and engage in activities like mindfulness breathing, health coaching, and journaling. Specific eligibility criteria are not provided.
What is being tested?
The study tests the compliance, usability, and satisfaction with a new home-use device that combines electrical nerve stimulation (TENS), sound therapy, and integrative health practices for treating cLBP. It's a pilot study to see how well participants can stick to using this device as intended.
What are the potential side effects?
While specific side effects are not listed for this trial, TENS devices may cause skin irritation or discomfort where the pads attach. Integrative health modalities typically have minimal side effects but could include emotional discomfort from reflection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had lower back pain for more than 3 months.
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I am 18 years old or older.
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I am not taking any benzodiazepines or sleep-inducing drugs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have back pain that spreads down my leg.
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I have back pain due to a rheumatic or inflammatory condition.
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I have had cancer in the past.
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I have a history of heart disease.
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I have back pain due to spondylolisthesis or spinal stenosis.
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My back pain is due to an injury, fracture, dislocation, or past surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
compliance rate
Secondary study objectives
satisfaction rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: device groupExperimental Treatment1 Intervention
Group II: Integrative health modality groupActive Control1 Intervention

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Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,435 Previous Clinical Trials
1,621,643 Total Patients Enrolled
Molly SturgesPrincipal InvestigatorUniversity of Minnesota
~11 spots leftby Aug 2025
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