Impact of DuoTherm on Opioid Use and Chronic Low Back Pain

Opioid Use Clinical Trial

Official title:

Addressing Opioid Use Disorder With an External Multimodal Neuromodulation Device: Clinical Evaluation of DuoTherm for Opioid-Sparing in Chronic Low Back Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04494698
• Other study ID #: DuoThermChronic
• Secondary ID: 4R44DA049631
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 23, 2022
• Est. completion date: July 29, 2024

Study information

• Verified date: February 2024
• Source: MMJ Labs LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate opioid use and pain change in chronic Low Back Pain with DuoTherm Compared to Active Control

Description:

100 patients with chronic low 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 an 8 channel TENS unit. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting pain and medication use.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 29, 2024
• Est. primary completion date: June 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Diagnosed with chronic low back pain by clinician
• Pain duration >3 months with or 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:

• Pacemaker
• 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
• Contraindication to any medication for pain management that would impact analgesic use record
• Inability to apply DuoTherm or Sham Device

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain
• Opioid Dependence
• Opioid Use
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Device:
• Duotherm VibraCool Back Device
Active New multimodal pain device
• TENS 8-channel unit
LG Smart TENS unit

Locations

Country	Name	City	State
United States	Sport and Spine Rehab Clinic	Fairfax	Virginia
United States	Sport and Spine Rehab Clinics	Landover	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
MMJ Labs LLC	National Institute on Drug Abuse (NIDA), Sport and Spine Rehab Clinical Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (8)

Cohen SP, Bhaskar A, Bhatia A, Buvanendran A, Deer T, Garg S, Hooten WM, Hurley RW, Kennedy DJ, McLean BC, Moon JY, Narouze S, Pangarkar S, Provenzano DA, Rauck R, Sitzman BT, Smuck M, van Zundert J, Vorenkamp K, Wallace MS, Zhao Z. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med. 2020 Jun;45(6):424-467. doi: 10.1136/rapm-2019-101243. Epub 2020 Apr 3. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Furlan AD, Giraldo M, Baskwill A, Irvin E, Imamura M. Massage for low-back pain. Cochrane Database Syst Rev. 2015 Sep 1;2015(9):CD001929. doi: 10.1002/14651858.CD001929.pub3. — View Citation

Maddalozzo GF, Kuo B, Maddalozzo WA, Maddalozzo CD, Galver JW. Comparison of 2 Multimodal Interventions With and Without Whole Body Vibration Therapy Plus Traction on Pain and Disability in Patients With Nonspecific Chronic Low Back Pain. J Chiropr Med. 2016 Dec;15(4):243-251. doi: 10.1016/j.jcm.2016.07.001. Epub 2016 Aug 25. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duotherm use	Daily diary of study device or TENS unit	6 months
Primary	Total Opioid use in morphine equivalent doses	Daily diary of analgesic use and dose	6 months
Primary	Change in opioid use in morphine equivalent doses	Daily diary of analgesic use and dose	Difference between first 2 weeks and last 2 weeks over 6 month period
Secondary	Change in current weekly pain from initial to final	Self-rated current pain on Numeric Rating Scale with 0 no pain and 11 maximum pain	Weekly for 3 weeks, then monthly at 1,3, and 6 months
Secondary	Change in 24 hour average pain weekly from initial to final	Self-rated pain over past 24 hours on Numeric Rating Scale with 0 no pain and 11 maximum pain	Weekly for 3 weeks, then monthly at 1,3, and 6 months
Secondary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain measures from initial to completion of study	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), Pain Intensity (2 questions, yielding possible scores of 2(low) and 10 (highest), and Depression scores (4 questions, yielding possible scores of 4(low) and 20 (most depressed).	Initial, 1 month, 3 months, completed at the end of 6 months