TENS Device and Integrative Health Techniques for Back Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be taking benzodiazepines or sedative hypnotics. Also, if you are using other lower back pain treatments, you must maintain a steady state for one month before starting the study.
Is the TENS device safe for humans?
How is the TENS Device and Integrative Health Techniques treatment for back pain different from other treatments?
What data supports the effectiveness of the treatment for back pain?
Research shows that TENS (a device that uses electrical currents to relieve pain) is commonly used by physical therapists to help with chronic pain, including back pain. Many patients report reduced pain, less need for medication, and better sleep when using TENS for chronic pain conditions.710111213
Who Is on the Research Team?
Molly Sturges
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use an at-home, multi-modal stimulation device including electrical and auditory stimulation, mindfulness breathing, health coaching, and reflective journaling
Follow-up
Participants are monitored for compliance, usability, and satisfaction with the device after the treatment period
What Are the Treatments Tested in This Trial?
Interventions
- At-home Multi-modal Stimulation Device
At-home Multi-modal Stimulation Device is already approved in United States, European Union for the following indications:
- Chronic pain
- Pain after surgery or a sudden injury
- Temporary pain associated with sore and aching muscles from exercise and household or work activities
- Arthritis
- Pain relief
- Muscle spasms
- Arthritis
- Period pain
- Pelvic pain caused by endometriosis
- Knee pain
- Sports injuries
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor