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Impact of DuoTherm on Opioid Use and Chronic Low Back Pain

Primary Purpose

Opioid-use Disorder, Chronic Low-back Pain, Opioid Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Duotherm VibraCool Back Device
TENS 8-channel unit
Sponsored by
MMJ Labs LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring opioid use, pain, medical device, analgesia, vibration, thermal, Buzzy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sport and Spine Rehab ClinicsRecruiting
  • Sport and Spine Rehab ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DuoTherm VibraCool Back Device

Multimodal TENS Unit

Arm Description

A low back pain relief device incorporating multiple speeds and patterns of vibration and optional heat, cold, or 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 daily for 20 minutes.

LG SMART TENS stimulator is a portable electrotherapy device 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.

Outcomes

Primary Outcome Measures

Total Opioid use in morphine equivalent doses
Daily diary of analgesic use and dose
Change in opioid use in morphine equivalent doses
Daily diary of analgesic use and dose

Secondary Outcome Measures

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
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
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).

Full Information

First Posted
July 28, 2020
Last Updated
October 19, 2022
Sponsor
MMJ Labs LLC
Collaborators
Sport and Spine Rehab Clinical Research Foundation, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04494698
Brief Title
Impact of DuoTherm on Opioid Use and Chronic Low Back Pain
Official Title
Addressing Opioid Use Disorder With an External Multimodal Neuromodulation Device: Clinical Evaluation of DuoTherm for Opioid-Sparing in Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MMJ Labs LLC
Collaborators
Sport and Spine Rehab Clinical Research Foundation, National Institute on Drug Abuse (NIDA)

4. Oversight

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.
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Chronic Low-back Pain, Opioid Use, Opioid Dependence
Keywords
opioid use, pain, medical device, analgesia, vibration, thermal, Buzzy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare 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 unit via an online video they will access in clinic, but care providers will not be informed of the study arm. An assessment for blinding will be adminstered at the end of the data collection for care providers and participants.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DuoTherm VibraCool Back Device
Arm Type
Active Comparator
Arm Description
A low back pain relief device incorporating multiple speeds and patterns of vibration and optional heat, cold, or 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 daily for 20 minutes.
Arm Title
Multimodal TENS Unit
Arm Type
Active Comparator
Arm Description
LG SMART TENS stimulator is a portable electrotherapy device 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.
Intervention Type
Device
Intervention Name(s)
Duotherm VibraCool Back Device
Other Intervention Name(s)
Vibracool plus heat or pressure, Buzzy
Intervention Description
Active New multimodal pain device
Intervention Type
Device
Intervention Name(s)
TENS 8-channel unit
Intervention Description
LG Smart TENS unit
Primary Outcome Measure Information:
Title
Total Opioid use in morphine equivalent doses
Description
Daily diary of analgesic use and dose
Time Frame
6 months
Title
Change in opioid use in morphine equivalent doses
Description
Daily diary of analgesic use and dose
Time Frame
Difference between first 2 weeks and last 2 weeks over 6 month period
Secondary Outcome Measure Information:
Title
Change in current weekly pain from initial to final
Description
Self-rated current pain on Numeric Rating Scale with 0 no pain and 11 maximum pain
Time Frame
Weekly for 3 weeks, then monthly at 1,3, and 6 months
Title
Change in 24 hour average pain weekly from initial to final
Description
Self-rated pain over past 24 hours on Numeric Rating Scale with 0 no pain and 11 maximum pain
Time Frame
Weekly for 3 weeks, then monthly at 1,3, and 6 months
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain measures from initial to completion of study
Description
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).
Time Frame
Initial, 1 month, 3 months, completed at the end of 6 months
Other Pre-specified Outcome Measures:
Title
Duotherm use
Description
Daily diary of study device or TENS unit
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Yes, eligibility is based on self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Baxter, MD
Phone
8778052899
Email
abaxter@mmjlabs.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jena Slaski
Phone
301-577-1115
Email
landoverclinic@ssrehab.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Baxter, MD
Organizational Affiliation
Pain Care Labs (a dba of MMJ Labs)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sport and Spine Rehab Clinics
City
Landover
State/Province
Maryland
ZIP/Postal Code
20785
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jena Slaski
Phone
301-577-1115
Email
landoverclinic@ssrehab.com
First Name & Middle Initial & Last Name & Degree
Jena Slaski
Facility Name
Sport and Spine Rehab Clinic
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jena Slaski
Phone
301-251-2777
Email
fairfaxclinic@ssrehab.com
First Name & Middle Initial & Last Name & Degree
Jena Slaski

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the clinical results reported in any publications, after deidentification, will be available for a period of 36 months after publication to achieve approved aims of any researcher who provides a methodologically sound proposal. Proposals should be directed to info@mmjlabs.com. To gain acccess, data requestors will need to sign a data access agreement.
IPD Sharing Time Frame
up to 36 months after publication of results
IPD Sharing Access Criteria
researchers providing approved methodologically sound proposals or requests
Citations:
PubMed Identifier
25639530
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.
Results Reference
background
PubMed Identifier
11690728
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.
Results Reference
background
PubMed Identifier
28017184
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.
Results Reference
background
PubMed Identifier
30146045
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.
Results Reference
background
PubMed Identifier
30445274
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.
Results Reference
background
PubMed Identifier
26329399
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.
Results Reference
background
PubMed Identifier
27857632
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.
Results Reference
background
PubMed Identifier
32245841
Citation
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.
Results Reference
background

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Impact of DuoTherm on Opioid Use and Chronic Low Back Pain

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