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

MMJ Labs LLC160 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

160

Conditions

Acute Low-back Pain Chronic Low-back Pain Pain, Intractable

Interventions

Duotherm VibraCool Back DeviceDEVICE

Active New multimodal pain device

TENS 8-channel unitDEVICE

LG Smart TENS unit

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (2)

Sport and Spine Rehab Clinics

Landover, Maryland, United States

Sport and Spine Rehab Clinic

Fairfax, Virginia, United States

Outcomes

Primary Outcomes

Change in current pain intensity from initial to final

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

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

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

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

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

Secondary Outcomes

Resolution of disability using PROMIS Pain Interference

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

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

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

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

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

Data from ClinicalTrials.gov

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