Impact of DuoTherm Compared to TENS on Pain and Disability With Acute and Chronic Low Back Pain

MMJ Labs

Status: Completed

Conditions: Chronic Low-back Pain; Acute Low-back Pain; Pain, Intractable

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)

DuoTherm for Low Back Pain

Details and patient eligibility

About

Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control

Full description

160 patients with moderate to severe acute or exacerbations of 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: 160 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (same cohort as enrolled with NCT04491175):

• Presentation for treatment of acute or acute exacerbation of chronic low back pain
• Self-report NRS measures >=4 (moderate to severe)
• 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 50 (device won't fit, initially thought to be BMI 30 but up to 50 included)
• 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 Active Control TENS Device

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

DuoTherm VibraCool Back Device

Experimental group

Description:

A multimodal low back pain relief device incorporating 8 mechanical stimulation patterns of vibration and 5 intensity settings with optional heat, cold, or pressure delivered through a sculpted metal plate attached by a belt and controlled by buttons on the belt. Patients will be instructed to use the device daily for 30 minutes.

Treatment:

Device: Duotherm VibraCool Back Device

Multimodal TENS Unit

Active Comparator group

Description:

LG SMART TENS stimulator is an 8-channel 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