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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Addressing Feasibility of the DuoTherm in Acute and Chronic Low Back Pain

Conditions
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Low Back Pain, Low Back Sprain, Low Back Pain, Recurrent

Intervention / Treatment
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* Device: Duotherm VibraCool Back Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DuoTherm VibraCool Back Device<br>Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes. | Device: Duotherm VibraCool Back Device<br>* Low back plate belt with mechanicothermal and pressure intervention options.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain: Visual Analog Scale (VAS) | Difference in 10 cm VAS printed on paper from 0 (no pain) to 10 (most pain) before and after use of the device, higher value indicates a greater pain reduction, 1.8 cm is considered clinically relevant. | Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation | 
| Participants' Choice in Thermal Options | One of four options: hot, cold, none, both | 30 minutes | 
| Would You Recommend | Binary approval or disapproval of device | After 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Pain Relief | 7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical Device, Buzzy, Vibration, thermomechanical