Evaluate the difference in opioid use, pain intensity and pain interference in patients with moderate to severe low back pain using DuoTherm multimodal harmonic mechanical stimulation (M-Stim) unit compared to Transcutaneous Electrical Nerve Stimulation (TENS)
160 patients with acute or exacerbations of chronic low back pain (LBP) presenting for chiropractic and rehabilitation care will be randomized to one of two conditions: an M-Stim pain relief belt device incorporating 8 patterns of vibration motors (and optional heat, cold, and pressure) delivered through a sculpted metal plate; or a 4-lead TENS unit with 8 channels of stimulation and adjustable intensity. Patients will be blinded to the hypothesis-driving intervention. They will be prompted daily by a Qualtrics text link to a secure data recording site collecting analgesic use and treatments, including opioid brand, dose, pill number, and source, and pain data, then weekly for 3 months (acute pain) or 6 months (chronic).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
The casing for the device is a 54" belt with 3-button haptic controller for on-off, therapy cycles(8) and intensity(5) levels.
LG SMART TENS stimulator is a portable electrotherapy devcie featuring transcutaneous electrical nerve stimulation (TENS) therapeutic device, which is used for pain relief. The stimulator sends a gentle electrical current to underlying nerves and muscle groups via electrodes applied on the skin. The parameters of the device are controlled by buttons on a controller with an adjustable intensity level.
Sport and Spine Rehab Clinics
Landover, Maryland, United States
Kaizo Health Fairfax
Fairfax, Virginia, United States
Opioid initiation in the opioid-naive
New opioid prescriptions for subjects without history of opioids for LBP
Time frame: All opioid diaries for 3 months
Opioid use in prior users
Change in milligram morphine equivalents (MME) reported daily
Time frame: 28 days (duration of daily recording)
Opioid Use Risk Factors in the Opioid-Naive
The difference in opioid use days, MME, and those using opioids more than 7 days after presentation
Time frame: All opioid diaries for 3 months
Opioid use in those with more severe pain
Opioid use days in those with the NIH Research Taskforce severity of moderate to severe in M-Stim versus TENS
Time frame: All opioid diaries for 6 months
Opioid prescribing compared to a contemporaneous national LPB prescribing of 25%
New opioid prescription rate for each intervention compared to nationally prevalent prescribing rates of 25% with moderate to severe pain in outpatient settings
Time frame: All opioid diaries for 6 months
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