Impact of DuoTherm on Acute Opioid Use and Low Back Pain
Sponsor
MMJ Labs LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04491175
Collaborator
Sport and Spine Rehab Clinical Research Foundation (Other), National Institute on Drug Abuse (NIDA) (NIH)
60
2
2
9.2
30
3.2
Study Details
Study Description
Brief Summary
Evaluate opioid use and pain change in acute Low Back Pain with DuoTherm Compared to TENS Therapy Unit
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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 plate; or a TENS unit with 8 channels of stimulation and adjustable intensity. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting pain and medication use.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
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 TENS units via a pre-made video, but care providers will not be informed of the study arm. An assessment for blinding will be administered at the end of the data collection for care providers and participants.
Primary Purpose:
Prevention
Official Title:
Addressing Opioid Use Disorder With an External Multimodal Neuromodulation Device: Clinical Evaluation of DuoTherm for Opioid-Sparing in Acute Low Back Pain
Actual Study Start Date
:
Jun 23, 2022
Anticipated Primary Completion Date
:
Feb 28, 2023
Anticipated Study Completion Date
:
Mar 31, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: DuoTherm A low back pain relief device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate attached with a belt and controlled by buttons on the belt. Patients will be instructed to use the device twice a day for 20 minutes. |
Device: DuoTherm
New combination device comprising a sculpted low back plate with multiple sensory modalities held in place with a neoprene belt capable of being tightened with patient control of variations in sensory modalities.
Other Names:
|
| Active Comparator: Multimodal TENS An 8-channel TENS unit (LG Smart). Patients will be instructed to use the TENS twice a day for 20 minutes. |
Device: TENS
LG SMART TENS stimulator is a portable electgrotherapy devcie featuring transcutaneous electrical nerve stimulation (TENS) therapeitud devcie, 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Opioid use in morphine equivalent doses [3 months]
Daily diary of analgesic use and dose
- Opioid initiation [initial 15 days]
Use of any opioids, prescribed or borrowed
Secondary Outcome Measures
- Change in current weekly pain from initial to resolution [3 months]
Self-rated current pain on 0-11 NRS
- Change in 24 hour average pain weekly from initial to resolution [3 months]
Self-rated average pain over past 24 hours on 0-11 NRS
- Change in PROMIS Pain Interference measure from initial to completion of study [Initial to end of 3 months]
Change in Monthly Pain Interference score
- Change in PROMIS Pain Intensity measure from initial to completion of study [Initial to end of 3 months]
Change in Monthly Pain Intensity score
- Change in PROMIS Depression measures from initial to completion of study [Initial to end of 3 months]
Change in Monthly Depression score
Other Outcome Measures
- Duotherm use [3 months]
Daily diary of use of device or sham
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Male or female, aged 18-90 diagnosed with acute low back pain by clinician; pain duration <3 months without opioid prescription for this exacerbation; self-report NRS measures >4, 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:
- Opioid prescription in the past month; Radicular pain likely reflecting a surgical or mechanical problem; BMI greater than 30 (device won't fit); 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; a contraindication to any medication for pain management that would impact analgesic use record; inability to apply DuoTherm or TENS device; pacemaker that would render patients unable to use the TENS device.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sport and Spine Rehab Clinics | Landover | Maryland | United States | 20785 |
| 2 | Kaizo Health Fairfax | Fairfax | Virginia | United States | 22030 |
Sponsors and Collaborators
- MMJ Labs LLC
- Sport and Spine Rehab Clinical Research Foundation
- National Institute on Drug Abuse (NIDA)
Investigators
- Study Director: Jena Slaski, Sport and Spine Clinical Research Foundation
Study Documents (Full-Text)
None provided.More Information
Publications
- Abrecht CR, Cornelius M, Wu A, Jamison RN, Janfaza D, Urman RD, Campbell C, Smith M, Haythornthwaite J, Edwards RR, Schreiber KL. Prediction of Pain and Opioid Utilization in the Perioperative Period in Patients Undergoing Primary Knee Arthroplasty: Psychophysical and Psychosocial Factors. Pain Med. 2019 Jan 1;20(1):161-171. doi: 10.1093/pm/pny020.
- Darnall BD, Colloca L. Optimizing Placebo and Minimizing Nocebo to Reduce Pain, Catastrophizing, and Opioid Use: A Review of the Science and an Evidence-Informed Clinical Toolkit. Int Rev Neurobiol. 2018;139:129-157. doi: 10.1016/bs.irn.2018.07.022. Epub 2018 Aug 6. Review.
- Davis CS, Lieberman AJ, Hernandez-Delgado H, Suba C. Laws limiting the prescribing or dispensing of opioids for acute pain in the United States: A national systematic legal review. Drug Alcohol Depend. 2019 Jan 1;194:166-172. doi: 10.1016/j.drugalcdep.2018.09.022. Epub 2018 Nov 3.
- Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, Delitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. Phys Ther. 2015 Feb;95(2):e1-e18. doi: 10.2522/ptj.2015.95.2.e1.
- Edwards RR, Haythornthwaite JA, Smith MT, Klick B, Katz JN. Catastrophizing and depressive symptoms as prospective predictors of outcomes following total knee replacement. Pain Res Manag. 2009 Jul-Aug;14(4):307-11.
- Farber K, Wieland LS. Massage for Low-back Pain. Explore (NY). 2016 May-Jun;12(3):215-7. doi: 10.1016/j.explore.2016.02.014. Epub 2016 Mar 2.
- Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
- French SD, Cameron M, Walker BF, Reggars JW, Esterman AJ. Superficial heat or cold for low back pain. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD004750. Review.
- Furlan AD, Giraldo M, Baskwill A, Irvin E, Imamura M. Massage for low-back pain. Cochrane Database Syst Rev. 2015 Sep 1;(9):CD001929. doi: 10.1002/14651858.CD001929.pub3. Review.
- Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. Review.
- Nadler SF, Steiner DJ, Petty SR, Erasala GN, Hengehold DA, Weingand KW. Overnight use of continuous low-level heatwrap therapy for relief of low back pain. Arch Phys Med Rehabil. 2003 Mar;84(3):335-42.
- Stumbo SP, Yarborough BJ, McCarty D, Weisner C, Green CA. Patient-reported pathways to opioid use disorders and pain-related barriers to treatment engagement. J Subst Abuse Treat. 2017 Feb;73:47-54. doi: 10.1016/j.jsat.2016.11.003. Epub 2016 Nov 15.
Responsible Party:
Amy Lynn Baxter,
CEO,
MMJ Labs LLC
ClinicalTrials.gov Identifier:
NCT04491175
Other Study ID Numbers:
- DuothermAcute
- 4R44DA049631-02
First Posted:
Jul 29, 2020
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Amy Lynn Baxter,
CEO,
MMJ Labs LLC
Additional relevant MeSH terms: