Impact of DuoTherm on Opioid Use and Chronic Low Back Pain

Not Applicable

Active, not recruiting

• Conditions: Chronic Low-back Pain; Opioid Use; Opioid Dependence; Opioid-use Disorder
• Interventions: Device: Duotherm VibraCool Back Device; Device: TENS 8-channel unit

• Registration Number: NCT04494698
• Lead Sponsor: MMJ Labs LLC

Brief Summary

Evaluate opioid use and pain change in chronic Low Back Pain with DuoTherm Compared to Active Control

Detailed Description

100 patients with chronic low back pain presenting for chiropractic and rehabilitation care will be randomized to one of two conditions: a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate; or an 8 channel prescription TENS unit. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting pain and medication use.

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-31
• Study Start: 2022-06-23
• Primary Completion: 2024-07-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Study Completion: 2024-11-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnosed with chronic low back pain by clinician
• Pain duration >3 months with or without opioid prescription for this exacerbation
• Self-report NRS measures >4
• Capacity to understand all relevant risks and potential benefits of the study (informed consent)
• Willingness to communicate information on prescription pill # and dose, or dose and pill type if medication is prescribed by someone else.

Exclusion Criteria

• Pacemaker
• Radicular pain likely reflecting a surgical or mechanical problem
• BMI greater than 30 (device won't fit)
• Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)
• Diabetic neuropathy rendering a patient unable to determine if the device is too hot
• New neurologic deficits
• Skin lesions over the low back area
• Contraindication to any medication for pain management that would impact analgesic use record
• Inability to apply DuoTherm or Sham Device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DuoTherm VibraCool Back Device	Duotherm VibraCool Back Device	A low back pain relief device incorporating multiple speeds and patterns of vibration and optional heat, cold, or 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 daily for 20 minutes.
Multimodal TENS Unit	TENS 8-channel unit	LG SMART TENS stimulator is a portable electrotherapy device featuring transcutaneous electrical nerve stimulation (TENS) therapeutic device, which is used for pain relief. The stimulator sends a gentle electrical current to underlying nerves and muscle groups via electrodes applied on the skin. The parameters of the device are controlled by buttons on a controller with an adjustable intensity level.

Primary Outcome Measures

Name	Time	Method
Total Opioid use in morphine equivalent doses in opioid naive and prior users	6 months	Daily diary of analgesic use and dose
Change in opioid use in morphine equivalent doses for prior users	Difference between first 2 weeks and last 2 weeks over 6 month period	Daily diary of analgesic use and dose
Prolonged opioid use	Use after day 7 in opioid naive patients for either 3 or 6 month followup	Use past the time associated with increased pain or opioid use in opioid naive who initiate use

Secondary Outcome Measures

Name	Time	Method
Change in current pain intensity from initial to final	Daily for 30 days, weekly for 3 weeks, then monthly until 6 months	Self-rated current pain on Numeric Rating Scale with 0 no pain and 10 maximum pain
Change in 24 hour average pain weekly from initial to final	Daily for 30 days, Weekly for 3 weeks, then monthly until 6 months	Self-rated pain over past 24 hours on Numeric Rating Scale with 0 no pain and 10 maximum pain
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain intensity (8a) measures from initial to completion of study	Initial, then monthly completed at the end of 6 months	Response formats for all scales are a 5-point ordinal rating scale of "Not at all," "A little bit," "Somewhat," "Quite a bit," and "Very much," where lower scores are better and higher scores indicate worse pain. The outcomes being addressed are Change in Monthly Pain Interference (8 questions, yielding possible scores of 8 (low) to 40 (highest) normed on a T-Score where 50 is the average in the United States

Trial Locations

Locations (2)

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

Sport and Spine Rehab Clinic; 🇺🇸 Fairfax, Virginia, United States