Impact of DuoTherm on Opioid Use and Chronic Low Back Pain
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Low Back Pain
- Opioid Dependence
- Opioid Use
- Opioid Use Disorder
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Care Provider)Masking Description: Participants will be instructed that there are interventions being evaluated for low back pain and the impact of the medical device on medication use and pain, and that they will be self-assessing pain and use of prescribed and over the counter medications. Study staff will train them on the device or sham, but care providers will not be informed of the study arm. An assessment for blinding will be adminstered at the end of the data collection for care providers and participants.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
Description
100 patients with chronic low back pain presenting for chiropractic and rehabilitation care will be stratified by gender and 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 me...
100 patients with chronic low back pain presenting for chiropractic and rehabilitation care will be stratified by gender and 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 a sham "posture plate" with a sculpted metal plate on a belt but no active heat, cold, pressure, or vibration. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting pain and medication use.
Tracking Information
- NCT #
- NCT04494698
- Collaborators
- Sport and Spine Rehab Clinical Research Foundation
- Investigators
- Principal Investigator: Amy Baxter, MD Pain Care Labs (a dba of MMJ Labs)
Get Well Soon