Impact of DuoTherm on Acute Opioid Use and Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04491175
• Other study ID #: DuothermAcute
• Secondary ID: 4R44DA049631-02
• 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 acute Low Back Pain with DuoTherm Compared to TENS Therapy Unit

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• 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:

• 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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Opioid Use

Intervention

Device:
• DuoTherm
New multi-modal 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.
• TENS
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.

Locations

Country	Name	City	State
United States	Kaizo Health Fairfax	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 (12)

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. — 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

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. doi: 10.1155/2009/273783. — View Citation

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. — 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

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;2006(1):CD004750. doi: 10.1002/14651858.CD004750.pub2. — 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

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. No abstract available. — View Citation

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. doi: 10.1053/apmr.2003.50103. — 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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duotherm use	Daily diary of use of device or sham	3 months
Primary	Opioid use in morphine equivalent doses	Daily diary of analgesic use and dose	3 months
Primary	Opioid initiation	Use of any opioids, prescribed or borrowed	initial 15 days
Secondary	Change in current weekly pain from initial to resolution	Self-rated current pain on 0-11 NRS	3 months
Secondary	Change in 24 hour average pain weekly from initial to resolution	Self-rated average pain over past 24 hours on 0-11 NRS	3 months
Secondary	Change in PROMIS Pain Interference measure from initial to completion of study	Change in Monthly Pain Interference score	Initial to end of 3 months
Secondary	Change in PROMIS Pain Intensity measure from initial to completion of study	Change in Monthly Pain Intensity score	Initial to end of 3 months
Secondary	Change in PROMIS Depression measures from initial to completion of study	Change in Monthly Depression score	Initial to end of 3 months