Impact of DuoTherm on Opioid Use and Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain; Opioid Use

• Registration Number: NCT04491175
• Lead Sponsor: MMJ Labs LLC

Brief Summary

Evaluate the difference in opioid use, pain intensity and pain interference in patients with moderate to severe low back pain using DuoTherm multimodal harmonic mechanical stimulation (M-Stim) unit compared to Transcutaneous Electrical Nerve Stimulation (TENS)

Detailed Description

160 patients with acute or exacerbations of chronic low back pain (LBP) presenting for chiropractic and rehabilitation care will be randomized to one of two conditions: an M-Stim pain relief belt device incorporating 8 patterns of vibration motors (and optional heat, cold, and pressure) delivered through a sculpted metal plate; or a 4-lead TENS unit with 8 channels of stimulation and adjustable intensity. Patients will be blinded to the hypothesis-driving intervention. They will be prompted daily by a Qualtrics text link to a secure data recording site collecting analgesic use and treatments, including opioid brand, dose, pill number, and source, and pain data, then weekly for 3 months (acute pain) or 6 months (chronic).

Study Timeline

• Study First Submitted: 2019-09-15
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-29
• Study Start: 2022-06-23
• Primary Completion: 2024-07-09
• Study Completion: 2025-05-29
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-13
• Last Update Posted: 2025-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Age18-90
• Moderate-to-severe low back pain with numeric rating scale >=4/10
• Capacity to understand informed consent
• Willingness to communicate prescriptions, pill number, dose, and source of opioids used

Exclusion Criteria

• Opioid prescription in the past month for acute LBP (new pain <3 months)
• Radicular pain
• BMI greater than 50 (device won't fit)
• Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)
• Diabetic neuropathy
• New neurologic deficits
• Skin lesions over the low back area
• Contraindication to any medication for pain management
• Inability to apply DuoTherm or TENS device
• Pacemaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Opioid initiation in the opioid-naive	All opioid diaries for 3 months	New opioid prescriptions for subjects without history of opioids for LBP
Opioid use in prior users	28 days (duration of daily recording)	Change in milligram morphine equivalents (MME) reported daily

Secondary Outcome Measures

Name	Time	Method
Opioid Use Risk Factors in the Opioid-Naive	All opioid diaries for 3 months	The difference in opioid use days, MME, and those using opioids more than 7 days after presentation
Opioid use in those with more severe pain	All opioid diaries for 6 months	Opioid use days in those with the NIH Research Taskforce severity of moderate to severe in M-Stim versus TENS
Opioid prescribing compared to a contemporaneous national LPB prescribing of 25%	All opioid diaries for 6 months	New opioid prescription rate for each intervention compared to nationally prevalent prescribing rates of 25% with moderate to severe pain in outpatient settings

Trial Locations

Locations (2)

Sport and Spine Rehab Clinics; 🇺🇸 Landover, Maryland, United States

Kaizo Health Fairfax; 🇺🇸 Fairfax, Virginia, United States