Clinical trial NCT04494841: Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain
Official title: Addressing Feasibility of the DuoTherm in Acute and Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Low Back Sprain
Low Back Pain, Recurrent
Keywords: Medical Device
Buzzy
Vibration
thermomechanical
Lead sponsor: MMJ Labs LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Sport and Spine Rehab Clinical Research Foundation
First posted: 2020-07-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Consecutive low back pain patients were offered to try a new device and give feedback on a prototype. Once the feedback was obtained, the changes were incorporated into a production-ready model and re-evaluated.
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Detailed description: To facilitate data collection of a short-term intervention, the investigators chose to enroll patients from a mixed physical therapy/chiropractic practice with demographic and economic diversity in the metro Washington area. The neuromodulatory device will have patient controlled frequencies at 50Hz, 100Hz, and 180Hz attached to a 12 x 22 cm metal plate ergonomically curved to fit the low back. The device will be wearable with a neoprene belt on both sides for patients to adjust pressure. The metal pocket in our device holds a 221g clay pack capable of being frozen to 15F or heated to 110F or patient tolerance, with 30 minute thermal capacity. A convenience sample of 10 patients at the clinic was invited to give feedback on the prototype device after informed consent. Changes suggested were incorporated and after informed consent a second group of ten gave will give feedback with the production-ready device.

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

Primary outcomes:
measure: Change in Pain: Visual Analog Scale (VAS)
timeFrame: Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation
measure: Participants' Choice in Thermal Options
timeFrame: 30 minutes
measure: Would You Recommend
timeFrame: After 30 minutes
Secondary outcomes:
measure: Subjective Pain Relief
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Sport and Spine Rehab Clinic
state: Maryland
Study officials:
affiliation: MMJ Labs LLC
name: Amy Baxter, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lurie RC, Cimino SR, Gregory DE, Brown SHM. The effect of short duration low back vibration on pain developed during prolonged standing. Appl Ergon. 2018 Feb;67:246-251. doi: 10.1016/j.apergo.2017.10.007. Epub 2017 Nov 1.
citation: Ueki S, Yamagami Y, Makimoto K. Effectiveness of vibratory stimulation on needle-related procedural pain in children: a systematic review. JBI Database System Rev Implement Rep. 2019 Jul;17(7):1428-1463. doi: 10.11124/JBISRIR-2017-003890.