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

Trial Summary

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 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. ^{1 2 3 4 5}

Is the TENS device safe for humans?

Research suggests that transcutaneous electrical nerve stimulation (TENS) is generally safe for humans, as it is considered a non-drug alternative for pain relief with fewer side effects compared to narcotics and anti-inflammatory medications. ^{6 7 8 9 10}

How is the TENS Device and Integrative Health Techniques treatment for back pain different from other treatments?

This treatment is unique because it combines a TENS device, which provides non-invasive pain relief by sending electrical impulses through the skin, with integrative health techniques, offering a multi-modal approach that may enhance pain management compared to using TENS alone. ^{1 8 11 12 13}

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.

Research Team

Molly Sturges

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Impact of transcutaneous electrical nerve stimulation on sleep in chronic low back pain: a real-world retrospective cohort study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation: its role in the control of chronic pain. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Trigeminal neuralgia: sudden and long-term remission with transcutaneous electrical nerve stimulation. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

A Meta-Analysis of Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Literature Review and Meta-Analysis of Transcutaneous Electrical Nerve Stimulation in Treating Chronic Back Pain. [2022]

9. England 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). [2022]

10. United States 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. [2018]

11. Netherlands 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. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation and acupuncture-like transcutaneous electrical nerve stimulation for chronic low back pain. [2018]

13. England pubmed.ncbi.nlm.nih.gov

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