Impact of DuoTherm on Opioid Use and Chronic Low Back Pain

MMJ Labs

Status: Active, not recruiting

Conditions: Chronic Low-back Pain; Opioid-use Disorder; Opioid Use; Opioid Dependence

Treatments: Device: TENS 8-channel unit; Device: Duotherm VibraCool Back Device

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04494698

4R44DA049631 (U.S. NIH Grant/Contract)

DuoThermChronic

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

DuoTherm VibraCool Back Device

Active Comparator group

Description:

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.

Treatment:

Device: Duotherm VibraCool Back Device

Multimodal TENS Unit

Active Comparator group

Description:

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.

Treatment:

Device: TENS 8-channel unit