TENS Device and Integrative Health Techniques for Back Pain

Recruiting in Palo Alto (17 mi)

Overseen by Molly Sturges

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Minnesota

Must not be taking: Benzodiazepines, Sedative hypnotics

Disqualifiers: Heart disease, Epilepsy, Cancer, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

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.

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}

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

Trial 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 (Other)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Minnesota Minneapolis, MN

Who Is Running the Clinical Trial?

University of Minnesota Lead Sponsor

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] The purpose of this study was to determine if transcutaneous electrical nerve stimulation (TENS) improves sleep in chronic low back pain (CLBP).

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

Clinical uses of TENS. A survey of physical therapists. [2019] A nationwide survey of physical therapy departments was conducted to investigate the clinical use of transcutaneous electrical nerve stimulation for patients with pain. The majority (64.8%) of the 196 respondents used TENS to relieve chronic pain (and, less frequently, acute pain) from a variety of disorders. Any one of eight modalities was reported to be used in conjunction with TENS for the same pain problems. Seven criteria were used to evaluate the effectiveness of TENS in relieving pain. Most clinicians applying TENS were satisfied with the effectiveness of the modality in relieving acute, chronic, and psychogenic pain. Pain relief with short-term use of TENS was more satisfactory than with long-term use.

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

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. [2022] Transcutaneous electrical nerve stimulation (TENS) is a popular pain treatment modality but its effectiveness in chronic pain management is unknown. This review is an update of the original Cochrane review published in Issue 3, 2001.

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

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. [2018] Transcutaneous electrical nerve stimulation (TENS) is used in a variety of different clinical settings to treat a range of different acute and chronic pain conditions and has become popular with both patients and health professionals.

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

Transcutaneous electrical nerve stimulation: its role in the control of chronic pain. [2004] An assessment was made of the effectiveness of long-term transcutaneous electrical nerve stimulation (TENS) in the treatment of chronic posttraumatic pain. Compensation Board files showed that 846 patients received TENS from 1975 to 1979, with more than 70% having intractable back pain. Of this group using TENS, 44.6% were free of disability, and an additional 36.2% were capable of modified work. Questionnaire responses were obtained from 563 of 637 patients receiving TENS in 1978 or 1979. At the six-month follow-up, most respondents (472, 83.8%) reported continuing benefit from TENS, including a reduction of pain (418, 74.2%), less need for medication (322, 57.2%), and improved sleep patterns (331, 58.8%). Only 13.6% of those who had returned to work reported no benefit from TENS, while 18.4% of those still unemployed reported no benefit. Among those who had returned to work (264 cases, 46.9% of respondents), benefit was reported equally by those with back injuries and by those with other injuries. The responses observed in this trial seem larger and more long-lasting than could be obtained by a placebo effect, and further attempts at a controlled trial may be warranted. However, there are major practical difficulties to such an investigation, and the resulting controversy could reduce the therapeutic effectiveness of TENS in conditions where alternative treatments are either ineffective or undesirable.

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

Trigeminal neuralgia: sudden and long-term remission with transcutaneous electrical nerve stimulation. [2013] To discuss a case of trigeminal neuralgia that responded to an accidental high-intensity discharge of electrical current delivered by a transcutaneous electrical nerve stimulator (TENS).

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

A Meta-Analysis of Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain. [2022] Transcutaneous electrical nerve stimulation (TENS) may provide a safe alternative to current side-effect-heavy narcotics and anti-inflammatories utilized in chronic low back pain. Therefore, we performed a meta-analysis to evaluate the efficacy of TENS for the treatment of chronic low back pain.

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

Literature Review and Meta-Analysis of Transcutaneous Electrical Nerve Stimulation in Treating Chronic Back Pain. [2022] This study is a meta-analysis of randomized controlled trials comparing the efficacy of transcutaneous electrical nerve stimulation (TENS) to a control and to other nerve stimulation therapies (NSTs) for the treatment of chronic back pain.

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] To investigate the efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for relief of pain in adults.

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] Transcutaneous electrical nerve stimulation (TENS) could offer a non-drug form of pain relief, but there is no consensus regarding its effectiveness for chronic musculoskeletal pain or chronic low back pain. A recent review of previous trial methods identified significant problems with low treatment fidelity. There is little information available to inform the development of a pragmatic implementation design for a TENS evaluation.

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] Transcutaneous electrical nerve stimulation (TENS) is a promising non-pharmacological modality for the management of chronic low back pain (CLBP), but its efficacy and mode of action have not been clearly established.

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

Transcutaneous electrical nerve stimulation and acupuncture-like transcutaneous electrical nerve stimulation for chronic low back pain. [2018] Transcutaneous electrical nerve stimulation (TENS), originally based on the gate-control theory of pain, is widely used for the treatment of chronic low back pain. Despite its wide use and theoretical rationale, there appears at first glance little scientific evidence to support its use. This Cochrane review examines the available evidence on TENS for the treatment of chronic back pain through an exhaustive search of the literature.

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

Exploring the evidence for using TENS to relieve pain. [2012] Transcutaneous electrical nerve stimulation (TENS) has several advantages as it is a non-addictive, non-invasive means of analgesia that is simple to use, portable and can give continuous analgesia for a variety of conditions. This article outlines how it works and examines the evidence on its efficacy and possible uses in clinical practice.