What side effects are associated with this type of intervention?

Common treatments for lower back pain that involve thermal modulation include heat therapy and TENS. Heat therapy, such as the application of heat packs, can cause minor side effects like skin irritation or burns if the heat source is too hot or applied for too long. TENS therapy, which uses electrical currents to relieve pain, is generally safe but may cause skin irritation at the electrode sites, and in rare cases, muscle twitching or discomfort. Both treatments are non-invasive and typically have fewer side effects compared to pharmacologic interventions.

What prior FDA approvals exist?

The FDA has approved various treatments for lower back pain, including non-pharmacologic options like Transcutaneous Electrical Nerve Stimulation (TENS) therapy, which uses electrical currents to relieve pain. While specific FDA approvals for thermal modulation devices like DuoTherm are not detailed, TENS therapy serves as a comparable treatment modality. Additionally, pharmacologic treatments such as NSAIDs and acetaminophen are commonly used, although their effectiveness for acute lumbosacral radiculopathy is not firmly established.

What other types of research exist?

Promising novel alternatives to DuoTherm for lower back pain patients include: 1) Radiofrequency denervation, which has shown efficacy in reducing chronic facet joint pain. 2) Spinal cord stimulation, which has been effective in managing chronic radicular pain and failed back surgery syndrome. 3) Scrambler therapy, which has demonstrated efficacy in treating chronic pain with a favorable safety profile. 4) Focused ultrasound, which provides thermal tissue ablation for pain relief in patients who are not candidates for standard treatments.

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Behavioural Intervention

DuoTherm vs TENS for Lower Back Pain

N/A

Waitlist Available

Research Sponsored by MMJ Labs LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capacity to understand all relevant risks and potential benefits of the study (informed consent)

Self-report NRS measures >4

Must not have

Inability to apply DuoTherm or TENS device

New neurologic deficits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from device application such as irritation at the site of placement or sensitivity reactions. Since it involves heat and vibration, there might also be risks of burns or aggravation of existing skin conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the risks and benefits of the study.

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

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

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I am 18-90 years old with new low back pain lasting less than 3 months, not treated with opioids, and my pain level is above 4.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot use DuoTherm or TENS devices.

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I have new issues with my nerves or brain function.

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I cannot take certain pain medications due to health reasons.

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I have nerve damage from diabetes that makes it hard to feel if something is too hot.

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I have skin lesions on my lower back.

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I have sharp pain likely due to a physical spine issue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioid initiation

Opioid use in morphine equivalent doses

Secondary study objectives

Change in 24 hour average pain daily from initial to resolution

Change in PROMIS Pain Interference measure from initial to completion of study

Change in current daily pain from initial to resolution

Other study objectives

Duotherm use

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: DuoThermActive Control1 Intervention

A low back pain relief device incorporating 8 harmonic patterns of mechanical stimulation (vibration) capable of neuromodulatory nociceptor block and vasodilation, 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 twice a day for 20 minutes.

Group II: Multimodal TENSActive Control1 Intervention

An 8-channel TENS unit (LG Smart). Patients will be instructed to use the TENS twice a day for 20 minutes.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lower back pain include thermal therapies, exercise therapy, and mind-body interventions. Thermal therapies, such as DuoTherm, work by applying heat to the affected area, which increases blood flow, reduces muscle stiffness, and alleviates pain through the relaxation of muscles and tissues. Exercise therapy aims to improve flexibility, strength, and overall function, which helps in reducing pain and preventing future episodes. Mind-body interventions, such as cognitive-behavioral therapy and mindfulness-based stress reduction, address the psychological aspects of pain, helping patients manage stress and improve their pain perception. These treatments are crucial for lower back pain patients as they offer non-pharmacologic options that can enhance physical function, reduce pain, and improve quality of life without the side effects associated with medications.

Continuous low-level heat wrap therapy provides more efficacy than Ibuprofen and acetaminophen for acute low back pain.