DuoTherm vs TENS for Lower Back Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments for moderate to severe lower back pain: the DuoTherm device and Transcutaneous Electrical Nerve Stimulation (TENS). DuoTherm uses a belt to deliver vibrations, heat, cold, and pressure to relieve pain, while TENS uses electrical currents. Researchers aim to determine which treatment more effectively reduces pain and opioid use. Suitable participants have experienced significant lower back pain for an extended period and are willing to share details about their current pain medication. As an unphased trial, this study provides an opportunity to explore innovative pain relief methods and contribute to advancing treatment options.
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 prior data suggests that these treatments are safe for lower back pain?
Research has shown that DuoTherm, a new device for relieving back pain, is safe to use. Studies have found it effective in reducing pain with few side effects. DuoTherm eases pain through vibrations and pressure, avoiding drugs and typically reducing risks.
Limited information exists on negative effects, but available data suggests it is well-tolerated. Users of DuoTherm have reported few problems, making it a promising option for those seeking to avoid medication. Prospective participants should consult a healthcare provider before joining a trial.12345Why are researchers excited about this trial's treatments?
DuoTherm is unique because it combines multiple modes of therapy—harmonic mechanical vibration, heat, cold, and pressure—into one wearable device for lower back pain relief. Unlike standard treatments like TENS units that focus solely on electrical stimulation, DuoTherm offers eight harmonic vibration patterns and five intensity levels, allowing for a tailored pain management experience. Researchers are excited about this multimodal approach because it targets pain relief from various angles, potentially offering more comprehensive relief for patients.
What evidence suggests that this trial's treatments could be effective for lower back pain?
Research shows that DuoTherm, a treatment in this trial for low back pain, effectively reduces pain using eight different vibration patterns. Studies have found that this type of mechanical stimulation can help with both sudden and long-term low back pain. Some patients in these studies regained normal function within six months. DuoTherm relaxes muscles and reduces swelling. While researchers continue to study its effect on lowering opioid use, it has already been shown to reduce pain levels.12367
Who Is on the Research Team?
Jena Slaski
Principal Investigator
Sport and Spine Clinical Research Foundation
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use either the DuoTherm M-Stim device or TENS unit daily for 30 minutes
Follow-up
Participants are monitored for opioid use and device effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- DuoTherm
- TENS
Find a Clinic Near You
Who Is Running the Clinical Trial?
MMJ Labs LLC
Lead Sponsor
Sport and Spine Rehab Clinical Research Foundation
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator