TENS Device and Integrative Health Techniques for Back Pain

Overseen By Grace Conchas

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Benzodiazepines, Sedative hypnotics

Disqualifiers: Heart disease, Epilepsy, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new at-home device designed to help people with chronic lower back pain. The device, a Transcutaneous Electrical Nerve Stimulator (TENS) with integrative health modalities, combines electrical stimulation, sounds, and techniques like mindfulness and journaling. Researchers aim to assess the device's ease of use and user satisfaction. The study seeks participants who have experienced lower back pain for over three months and are not currently using other back pain treatments. Participants must live near the University of Minnesota and be willing to follow the study instructions. As an unphased trial, this study offers a unique opportunity to explore innovative pain management techniques and contribute to advancing non-drug therapies.

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.

What prior data suggests that this multi-modal device is safe for people with chronic lower back pain?

Research has shown that TENS (Transcutaneous Electrical Nerve Stimulation) is generally safe for reducing pain. Studies have found that TENS can decrease pain levels without causing serious side effects. For instance, one study showed that people experienced less pain during or immediately after using TENS compared to those who didn't use it.

TENS is often used to treat conditions like arthritis and fibromyalgia, which cause long-lasting pain. Although the Centers for Medicare & Medicaid Services (CMS) do not cover TENS for chronic lower back pain alone, it remains safe to use.

The new device in the trial combines TENS with other methods like mindfulness breathing and health coaching. While specific safety data for this exact combination is not available, the components, such as TENS, have been shown to be safe in other contexts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the at-home multi-modal stimulation device for back pain because it offers a non-invasive, drug-free alternative to traditional treatments like pain medications and physical therapy. This device is unique because it combines transcutaneous electrical nerve stimulation (TENS) with integrative health techniques, providing a holistic approach to pain management. Unlike standard treatments that often require clinical visits, this device can be used conveniently at home, potentially increasing accessibility and adherence for patients. Additionally, the integration of multiple modalities aims to enhance pain relief and improve overall well-being, setting it apart from single-method treatments.

What evidence suggests that this multi-modal device is effective for chronic lower back pain?

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) can reduce pain more effectively than a placebo and typically does not cause serious side effects. For individuals with long-term lower back pain, TENS has been somewhat helpful, though not always superior to a placebo. In this trial, participants in the device group will use a new device that combines TENS with other treatments, which has shown promise in reducing pain more effectively than TENS alone. This suggests that a combination of treatments might be more beneficial for those with chronic lower back pain. While TENS and similar methods can help, their effectiveness varies from person to person. ^{6 7 8 9 10}

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

Must be able to understand English

I have had lower back pain for more than 3 months.

Must be within commuting distance to the University of Minnesota

Exclusion Criteria

A score of 10 on the PEG

Pregnant

Have an electrically implanted device, such as a pacemaker

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use an at-home, multi-modal stimulation device including electrical and auditory stimulation, mindfulness breathing, health coaching, and reflective journaling

12 weeks

Follow-up

Participants are monitored for compliance, usability, and satisfaction with the device after the treatment period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• At-home Multi-modal Stimulation Device

Trial Overview 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.

How Is the Trial Designed?

Group I: device group Experimental Treatment 1 Intervention

Group II: Integrative health modality group Active Control 1 Intervention

At-home Multi-modal Stimulation Device is already approved in United States, European Union for the following indications:

Approved in United States as TENS for:

• 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

Approved in European Union as TENS for:

• Pain relief
• Muscle spasms
• Arthritis
• Period pain
• Pelvic pain caused by endometriosis
• Knee pain
• Sports injuries

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

A nationwide survey of 196 physical therapy departments found that 64.8% of respondents use transcutaneous electrical nerve stimulation (TENS) primarily for chronic pain relief, indicating its widespread acceptance in clinical practice.

Clinicians reported higher satisfaction with TENS for short-term pain relief compared to long-term use, suggesting that while TENS is effective, its benefits may diminish over extended periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical uses of TENS. A survey of physical therapists. Paxton, SL.[2019]

Patients using transcutaneous electrical nerve stimulation (TENS) for chronic musculoskeletal pain reported that personalizing electrode placement and adjusting settings over time were crucial for optimizing pain relief.

A successful evaluation of TENS effectiveness should include a learning phase for patients to adapt their usage strategies, as outcomes can vary significantly based on how TENS is applied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problems, Solutions, and Strategies Reported by Users of Transcutaneous Electrical Nerve Stimulation for Chronic Musculoskeletal Pain: Qualitative Exploration Using Patient Interviews. Gladwell, PW., Badlan, K., Cramp, F., et al.[2018]

Transcutaneous electrical nerve stimulation (TENS) and acupuncture-like TENS (ALTENS) show potential in reducing pain and improving range of motion in patients with chronic low back pain, based on a review of six trials involving 288 participants.

The odds of experiencing pain improvement were significantly higher with ALTENS compared to placebo, with an odds ratio of 7.22, while TENS also showed a positive effect, indicating both methods may be beneficial for short-term pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation and acupuncture-like transcutaneous electrical nerve stimulation for chronic low back pain. Gadsby, JG., Flowerdew, MW.[2018]

Transcutaneous electrical nerve stimulation (TENS) is a non-addictive and non-invasive pain relief method that is easy to use and portable, making it suitable for various conditions.

TENS provides continuous analgesia, and the article reviews its efficacy and potential applications in clinical practice, highlighting its benefits as a pain management tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the evidence for using TENS to relieve pain. Wright, A.[2012]

A systematic review of 19 randomized controlled trials (RCTs) on transcutaneous electrical nerve stimulation (TENS) for chronic pain found that while active TENS showed positive analgesic outcomes in 10 out of 15 studies compared to inactive controls, the overall evidence is inconclusive due to poor methodological quality and variability in study designs.

The review highlighted a lack of clarity on the optimal stimulation parameters for TENS and emphasized the need for larger, well-designed multi-centre trials to better assess the long-term effectiveness of TENS in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Carroll, D., Moore, RA., McQuay, HJ., et al.[2018]

Transcutaneous electrical nerve stimulation (TENS) significantly reduces pain intensity during or immediately after treatment compared to placebo, based on a systematic review of 381 randomized controlled trials involving over 24,500 participants.

TENS also shows lower pain intensity compared to standard pharmacological and non-pharmacological treatments, with moderate-certainty evidence indicating it is effective and generally safe, as adverse events were mild and similar to those of comparators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). Johnson, MI., Paley, CA., Jones, G., et al.[2022]

In a study of 846 patients with chronic posttraumatic pain, particularly back pain, long-term use of transcutaneous electrical nerve stimulation (TENS) resulted in 44.6% of patients being free of disability and 36.2% able to perform modified work.

At a six-month follow-up, 83.8% of respondents reported continued benefits from TENS, including significant pain reduction and decreased medication use, suggesting that TENS provides lasting therapeutic effects beyond a placebo response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation: its role in the control of chronic pain. Fried, T., Johnson, R., McCracken, W.[2004]

Transcutaneous electrical nerve stimulation (TENS) significantly reduces pain in patients with chronic low back pain, with a standardized mean difference of 0.844 indicating substantial improvement based on a meta-analysis of 13 studies involving 267 patients.

TENS treatment for less than 5 weeks showed significant pain relief, while longer treatments did not yield the same level of effectiveness, suggesting optimal treatment duration for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Meta-Analysis of Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain. Jauregui, JJ., Cherian, JJ., Gwam, CU., et al.[2022]

A case study of a 36-year-old man with trigeminal neuralgia showed that transcutaneous electrical nerve stimulation (TENS) provided significant pain relief, especially after an accidental high-intensity discharge that led to three years of symptom remission.

This incident suggests that TENS can be a safe and effective initial treatment for trigeminal neuralgia, and the intense application may activate pain inhibitory pathways, warranting further research into its use for similar pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trigeminal neuralgia: sudden and long-term remission with transcutaneous electrical nerve stimulation. Thorsen, SW., Lumsden, SG.[2013]

In a study of 554 chronic low back pain (CLBP) patients using transcutaneous electrical nerve stimulation (TENS) over 10 weeks, those who reported improvement in pain interference with sleep experienced an increase in total sleep time by 29 minutes compared to those who did not improve.

The improved group also showed a lower periodic leg movement index, suggesting that TENS not only helps with pain but may also enhance sleep quality, highlighting the importance of sleep as an outcome measure in TENS effectiveness for CLBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of transcutaneous electrical nerve stimulation on sleep in chronic low back pain: a real-world retrospective cohort study. Gozani, SN., Ferree, TC., Moynihan, M., et al.[2022]

Transcutaneous electrical nerve stimulation (TENS) was found to be similar in efficacy to control treatments for pain relief in chronic back pain, indicating it may not be a superior option for managing pain compared to sham or placebo treatments.

However, TENS showed a significant short-term improvement in functional disability for patients with follow-up of less than 6 weeks, suggesting it may be beneficial for improving daily function in the early stages of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Literature Review and Meta-Analysis of Transcutaneous Electrical Nerve Stimulation in Treating Chronic Back Pain. Wu, LC., Weng, PW., Chen, CH., et al.[2022]

In a double-blind trial with 62 participants suffering from chronic low back pain, TENS significantly reduced pain intensity compared to sham-TENS, with effects lasting up to 24 hours after treatment.

Despite the pain relief observed, there were no significant changes in plasma levels of beta-endorphin or met-enkephalin, suggesting that the mechanism of action for TENS may not involve these specific pain-relief hormones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation effects on pain-intensity and endogenous opioids levels among chronic low-back pain patients: A randomised controlled trial. Ezema, CI., Onyeso, OK., Nna, EO., et al.[2022]

A systematic review of 25 randomized controlled trials involving 1281 participants found that while active TENS treatments showed positive analgesic outcomes in some studies, the overall evidence is inconsistent and lacks methodological rigor.

There was no significant difference in pain relief between High Frequency and Low Frequency TENS, indicating that both types may be equally effective, but the need for more robust, large-scale studies remains critical to better understand TENS's role in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Nnoaham, KE., Kumbang, J.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2746624/

Effectiveness of Transcutaneous Electrical Nerve Stimulation ... Self-applied TENS treatments of 45 minutes twice daily (minimum) for 6 weeks yielded a significant effect between groups over time for average low back pain.

2. bmjopen.bmj.com bmjopen.bmj.com/content/12/2/e051073

Efficacy and safety of transcutaneous electrical nerve ... There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.

3. frontiersin.org frontiersin.org/journals/pain-research/articles/10.3389/fpain.2025.1625420/full

Novel multimodal mechanical stimulation is superior to ... Conclusions: A multimodal M-Stim device reduced progression to cLBP significantly more than TENS. Both devices reduced pain initially, but M-Stim reduced pain ...

4. nejm.org nejm.org/doi/full/10.1056/NEJM199006073222303

A Controlled Trial of Transcutaneous Electrical Nerve ... We conclude that for patients with chronic low back pain, treatment with TENS is no more effective than treatment with a placebo, and TENS adds no apparent ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11733168/

Latest Advancements in Transcutaneous Electrical Nerve ... TENS and Electronic Muscle Stimulation (EMS) are non-invasive therapies widely used for pain relief and neuromuscular adaptation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8845179/

Efficacy and safety of transcutaneous electrical nerve ... There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0003999324012267

Usefulness and Safety of a Wearable Transcutaneous ... The group using TENS showed improved effects of early reduction in knee pain and when combined with exercise therapy, a reduction in time spent in light- ...

8. my.clevelandclinic.org my.clevelandclinic.org/health/treatments/15840-transcutaneous-electrical-nerve-stimulation-tens

Transcutaneous Electrical Nerve Stimulation (TENS) A TENS unit uses a mild electrical current to reduce pain. Providers use this therapy to treat conditions like osteoarthritis, tendinitis and fibromyalgia.

9. aetna.com aetna.com/cpb/medical/data/1_99/0011.html

Electrical Stimulation for Pain - Medical Clinical Policy ... It states that TENS is not reasonable and necessary for the treatment of chronic low back pain. The CMS will only cover TENS if individuals are enrolled in an ...

10. physio-pedia.com physio-pedia.com/Transcutaneous_Electrical_Nerve_Stimulation_(TENS)

Transcutaneous Electrical Nerve Stimulation (TENS) Emerging evidence suggests TENs may be helpful for people with spinal cord injury, and produce more significant analgesic effects when combined with exercise ( ...