Low Back Pain, Opioid Use
Conditions
Keywords
chronic pain, analgesia, medical device, opioid, low back pain, neuromodulation, multifidus
Brief summary
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)
Detailed description
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).
Interventions
DEVICEM-Stim
The casing for the device is a 54 belt with 3-button haptic controller for on-off, therapy cycles(8) and intensity(5) levels.
DEVICETENS
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.
Sponsors
Sport and Spine Rehab Clinical Research Foundation
National Institute on Drug Abuse (NIDA)
MMJ Labs LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants were blinded to which device powered the study hypothesis, and blinded to their assigned intervention until after documenting initial NRS pain intensity. The protocol statistician and study coordinator knew device assignments and had access to data, but did not conduct analysis. The PI and treating chiropractor were blinded to allocation and all data during enrollment, with the PI accessing data only after study completion. The analyzing statisticians were blinded to device assignment until completion of analysis. Success of participant blinding was tested with prompts, select if you received… control or treatment and How confident are you?
Intervention model description
A randomized, double-blind controlled trial with 3- (aLBP) or 6- month (cLPB) follow-up.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age18-90 * Moderate-to-severe low back pain with numeric rating scale \>=4/10 * Capacity to understand informed consent * Willingness to communicate prescriptions, pill number, dose, and source of opioids used
Exclusion criteria
* Opioid prescription in the past month for acute LBP (new pain \<3 months) * Radicular pain * BMI greater than 50 (device won't fit) * Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease) * Diabetic neuropathy * New neurologic deficits * Skin lesions over the low back area * Contraindication to any medication for pain management * Inability to apply DuoTherm or TENS device * Pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid use in prior users | 28 days (duration of daily recording) | Change in milligram morphine equivalents (MME) reported daily |
| Opioid initiation in the opioid-naive | All opioid diaries for 3 months | New opioid prescriptions for subjects without history of opioids for LBP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use Risk Factors in the Opioid-Naive | All opioid diaries for 3 months | The difference in opioid use days, MME, and those using opioids more than 7 days after presentation |
| Opioid use in those with more severe pain | All opioid diaries for 6 months | Opioid use days in those with the NIH Research Taskforce severity of moderate to severe in M-Stim versus TENS |
| Opioid prescribing compared to a contemporaneous national LPB prescribing of 25% | All opioid diaries for 6 months | New opioid prescription rate for each intervention compared to nationally prevalent prescribing rates of 25% with moderate to severe pain in outpatient settings |
Countries
United States
Outcome results
None listed