Acute Low-back Pain, Chronic Low-back Pain, Pain, Intractable
Conditions
Keywords
chronic low back pain, spine pain, medical device, analgesia, vibration, Multifidus
Brief summary
Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control
Detailed description
160 patients with moderate to severe acute or exacerbations of chronic low back pain presenting for chiropractic and rehabilitation care will be 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 an 8 channel prescription TENS unit. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting pain and medication use.
Interventions
Active New multimodal pain device
DEVICETENS 8-channel unit
LG Smart TENS unit
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
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants will be instructed that non-drug interventions are being evaluated for their impact on opioid use and pain with low back pain, and that they will be self-assessing pain and reporting use of prescribed and over-the-counter medications. Study staff will train them on the device or TENS units via a pre-made video, but investigators and outcomes assessors (statistician) will not be informed of the hypothesis-driving condition arm. An assessment for blinding will be administered at the end of the data collection for participants, asking whether participants believe they are in treatment or control, and how confident they are.
Intervention model description
Randomized active control
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
(same cohort as enrolled with NCT04491175): * Presentation for treatment of acute or acute exacerbation of chronic low back pain * Self-report NRS measures \>=4 (moderate to severe) * Capacity to understand all relevant risks and potential benefits of the study (informed consent) * Willingness to communicate information on prescription pill # and dose, or dose and pill type if medication is prescribed by someone else.
Exclusion criteria
* Pacemaker * Radicular pain likely reflecting a surgical or mechanical problem * BMI greater than 50 (device won't fit, initially thought to be BMI 30 but up to 50 included) * 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 or Active Control TENS Device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in current pain intensity from initial to final | Daily for 30 days, then weekly and monthly until 3 months (acute) or 6 months (chronic) | Self-rated current pain on Numeric Rating Scale with 0 no pain and 10 maximum pain |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference | Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic) | Response formats for all scales are a 5-point ordinal rating scale of Not at all, A little bit, Somewhat, Quite a bit, and Very much, where lower scores are better and higher scores indicate worse pain. The outcomes being addressed are Change in Monthly Pain Interference (8 questions, yielding possible scores of 8 (low) to 40 (highest) normed on a T-Score where 50 is the average in the United States, 40.7 is no disability, 55 is mild, 57.7 is moderate, and 65.7 is severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of disability using PROMIS Pain Interference | Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic) | Achievement of average pain interference of a T-Score of 50 at last recorded PROMIS Pain Interference |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (8a) measures in those with intractable pain as defined and compared with surgical multifidus intervention studies | Initial through 6 month measurements (or 13 week if chronic enrolled as acute) | Comparison between the experimental and active control interventions crosswalked with the Oswestry Disability outcomes in multifudus electrical stimulation studies. |
Countries
United States
Outcome results
None listed