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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-17

Study Completion Date

2021-02-18

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.

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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.

Conditions

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Low Back Pain Low Back Sprain Low Back Pain, Recurrent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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DuoTherm VibraCool Back Device

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.

Group Type EXPERIMENTAL

Duotherm VibraCool Back Device

Intervention Type DEVICE

Low back plate belt with mechanicothermal and pressure intervention options.

Interventions

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Duotherm VibraCool Back Device

Low back plate belt with mechanicothermal and pressure intervention options.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No