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Completed

NCT Number: NCT04494698

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

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

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Key information

Conditions

Acute Low-back Pain Agnosia Chronic Low-back Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Intractable Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sport and Spine Rehab Clinics, Landover, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duotherm VibraCool Back Device

Device

Active New multimodal pain device

Other names: Vibracool plus heat or pressure, Buzzy

TENS 8-channel unit

Device

LG Smart TENS unit

Primary outcomes

  1. Change in current pain intensity from initial to final

    Time frame: Daily for 30 days, then weekly and monthly until 3 months (acute) or 6 months (chronic)

    Self-rated current pain on Numeric Rating Scale with 0 no pain and 10 maximum pain

  2. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

    Time frame: Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)

    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, 40.7 is "no disability", 55 is mild, 57.7 is moderate, and 65.7 is severe

Secondary outcomes

  1. Resolution of disability using PROMIS Pain Interference

    Time frame: Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)

    Achievement of average pain interference of a T-Score of 50 at last recorded PROMIS Pain Interference

  2. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (8a) measures in those with intractable pain as defined and compared with surgical multifidus intervention studies

    Time frame: Initial through 6 month measurements (or 13 week if chronic enrolled as acute)

    Comparison between the experimental and active control interventions crosswalked with the Oswestry Disability outcomes in multifudus electrical stimulation studies.

Sponsors and collaborators

Lead sponsor

MMJ Labs LLC

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Sport and Spine Rehab Clinical Research Foundation

Registry information

Official study title

Addressing Pain and Disability From Low Back Pain With an External Multimodal Neuromodulation Device

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jul 31, 2020
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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