N/A N=20 Device Feasibility

Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain

Low Back Pain · Low Back Sprain · Low Back Pain, Recurrent

Bottom Line

View on ClinicalTrials.gov: NCT04494841 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2022

Primary outcome: Primary: Change in Pain: Visual Analog Scale (VAS) — 2.1 units on a scale (centimeters)

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Duotherm VibraCool Back Device (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MMJ Labs LLC
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain: Visual Analog Scale (VAS)	2.1	—
PRIMARY Participants' Choice in Thermal Options	9; 11; 0; 0	—
PRIMARY Would You Recommend	20; 0	—
SECONDARY Subjective Pain Relief	5.3	—

Summary

Ten patients with acute or chronic low back pain will be invited to try a multimodal device for 20 minutes. Pain will be recorded prior to and after use, and feedback on the device will be elicited.

Eligibility Criteria

Inclusion Criteria

Acute or chronic low back pain as chief complaint
Capacity to understand all relevant risks and potential benefits of the study (informed consent);
Willingness to communicate information

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04494841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.