Impact of DuoTherm on Acute Opioid Use and Low Back Pain
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Low Back Pain
- Opioid Use
- 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: Prevention
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
Description
60 patients with acute 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 pla...
60 patients with acute 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 #
- NCT04491175
- Collaborators
- Sport and Spine Rehab Clinical Research Foundation
- National Institute on Drug Abuse (NIDA)
- Investigators
- Study Director: Jena Slaski Sport and Spine Clinical Research Foundation
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