DuoTherm vs TENS for Lower Back Pain

Recruiting at 2 trial locations

Overseen By Jena Slaski

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MMJ Labs LLC

Must not be taking: Opioids

Disqualifiers: Radicular pain, BMI > 50, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

160 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares a belt that provides vibration, heat, cold, and pressure (DuoTherm) to a device that uses electrical stimulation in patients with acute low back pain. DuoTherm helps by relaxing muscles and reducing inflammation, while the other device blocks pain signals from reaching the brain. The electrical stimulation device has been used for pain relief in various conditions, including chronic low back pain, but its effectiveness needs more research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow chronic opioid use for pain lasting 3 months or more. If you are on opioids for less than 3 months, you may not be eligible.

What data supports the effectiveness of the treatment DuoTherm vs TENS for Lower Back Pain?

Research shows that TENS (a treatment using electrical currents to relieve pain) can reduce the intensity of chronic low back pain more effectively than a placebo, especially in the short term. However, its long-term effectiveness is less clear, and results can vary based on how TENS is applied. ^{1 2 3 4 5}

Is TENS safe for treating low back pain?

TENS (transcutaneous electrical nerve stimulation) is generally considered safe for treating low back pain, with limited data on adverse effects. It is a non-drug therapy that has been used for both acute and chronic pain relief. ^{3 6 7 8 9}

How does the DuoTherm treatment differ from TENS for lower back pain?

The DuoTherm treatment is unique because it combines heat therapy with another method, potentially offering a different mechanism of action compared to TENS, which uses electrical impulses to relieve pain. This combination might provide a novel approach to managing lower back pain by addressing both muscle relaxation and nerve stimulation. ^{3 8 9 10 11}

Research Team

Jena Slaski

Principal Investigator

Sport and Spine Clinical Research Foundation

Eligibility Criteria

This trial is for adults aged 18-90 with acute low back pain lasting less than 3 months, who haven't been prescribed opioids for this episode. Participants must be able to understand the study and report on their medication use. Those with a BMI over 30, recent opioid prescriptions, pacemakers, certain medical conditions like Raynaud's or diabetic neuropathy, or skin issues in the low back area cannot join.

Inclusion Criteria

I understand the risks and benefits of the study.

I rate my pain or symptom as more than 4 on a scale of 0 to 10.

My pain has lasted less than 3 months and I haven't taken opioids for it.

Exclusion Criteria

I cannot use DuoTherm or TENS devices.

You weigh too much for the device to fit properly.

You have a pacemaker that would prevent you from using the TENS device.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either the DuoTherm M-Stim device or TENS unit daily for 30 minutes

1 month

Daily use with remote data collection

Follow-up

Participants are monitored for opioid use and device effectiveness

3 months

Treatment Details

Interventions

• DuoTherm
• TENS

Trial Overview The study compares DuoTherm therapy against TENS (Transcutaneous Electrical Nerve Stimulation) to see which one better reduces opioid use and eases acute lower back pain. Patients will self-report their pain levels and any medications taken during the trial period.

Participant Groups

Group I: M-Stim Experimental Treatment 1 Intervention

DuoTherm is a novel multimodal low back pain relief device incorporating 8 harmonic vibration patterns of mechanical stimulation (M-Stim), and optional heat, cold, and pressure delivered through a sculpted metal plate attached with a belt and controlled by buttons on the belt. Patients will be instructed to use the device at least daily for 30 minutes.

Group II: TENS Active Control 1 Intervention

A prescription 4-lead 8-channel TENS unit (LG Smart). Patients will be instructed to use the TENS at least daily for 30 minutes.

Who Is Running the Clinical Trial?

MMJ Labs LLC

Lead Sponsor

Trials

4

Recruited

630+

Sport and Spine Rehab Clinical Research Foundation

Collaborator

Trials

21

Recruited

1,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

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 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) 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]

References

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

What makes transcutaneous electrical nerve stimulation work? Making sense of the mixed results in the clinical literature. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

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

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

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Does transcutaneous electrical nerve stimulation affect pain, neuropathic pain, and sympathetic skin responses in the treatment of chronic low back pain? A randomized, placebo-controlled study. [2022]

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

Is TENS purely a placebo effect? A controlled study on chronic low back pain. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Transcutaneous electric nerve stimulation (TENS) for acute low back pain: systematic review. [2021]

7. 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]

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

Transcutaneous electrical nerve stimulation reduces acute low back pain during emergency transport. [2006]

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

Age Group Comparisons of TENS Response Among Individuals With Chronic Axial Low Back Pain. [2018]

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

Pain relief by transcutaneous electric nerve stimulation with bidirectional modulated sine waves in patients with chronic back pain: a randomized, double-blind, sham-controlled study. [2022]

11. Brazil pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized clinical trial. [2019]