NCT04494841

Brief Summary

Ten patients with acute or chronic low back pain will be invited to try a multimodal device for 20 minutes. Pain will be recorded prior to and after use, and feedback on the device will be elicited.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2021

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

October 21, 2022

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

July 28, 2020

Results QC Date

August 10, 2022

Last Update Submit

October 20, 2022

Conditions

Low Back PainLow Back SprainLow Back Pain, Recurrent

Keywords

Medical DeviceBuzzyVibrationthermomechanical

Outcome Measures

Primary Outcomes (3)

  • Change in Pain: Visual Analog Scale (VAS)

    Difference in 10 cm VAS printed on paper from 0 (no pain) to 10 (most pain) before and after use of the device, higher value indicates a greater pain reduction, 1.8 cm is considered clinically relevant.

    Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation

  • Participants' Choice in Thermal Options

    One of four options: hot, cold, none, both

    30 minutes

  • Would You Recommend

    Binary approval or disapproval of device

    After 30 minutes

Secondary Outcomes (1)

  • Subjective Pain Relief

    30 minutes

Study Arms (1)

DuoTherm VibraCool Back Device

EXPERIMENTAL

Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.

Device: Duotherm VibraCool Back Device

Interventions

Duotherm VibraCool Back DeviceDEVICE

Low back plate belt with mechanicothermal and pressure intervention options.

DuoTherm VibraCool Back Device

Eligibility Criteria

Age18 Years - 90 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsYes based on self-representation
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute or chronic low back pain as chief complaint
  • Capacity to understand all relevant risks and potential benefits of the study (informed consent);
  • Willingness to communicate information

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport and Spine Rehab Clinic

Rockville, Maryland, 20852, United States

Location

Related Publications (7)

  • 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.

    PMID: 28017184BACKGROUND

  • 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.

    PMID: 30146045BACKGROUND

  • 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.

    PMID: 30445274BACKGROUND

  • Ballard A, Khadra C, Adler S, Trottier ED, Le May S. Efficacy of the Buzzy Device for Pain Management During Needle-related Procedures: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Jun;35(6):532-543. doi: 10.1097/AJP.0000000000000690.

    PMID: 30829735BACKGROUND

  • Lurie RC, Cimino SR, Gregory DE, Brown SHM. The effect of short duration low back vibration on pain developed during prolonged standing. Appl Ergon. 2018 Feb;67:246-251. doi: 10.1016/j.apergo.2017.10.007. Epub 2017 Nov 1.

    PMID: 29122196BACKGROUND

  • Ueki S, Yamagami Y, Makimoto K. Effectiveness of vibratory stimulation on needle-related procedural pain in children: a systematic review. JBI Database System Rev Implement Rep. 2019 Jul;17(7):1428-1463. doi: 10.11124/JBISRIR-2017-003890.

    PMID: 31021972BACKGROUND

  • Baxter AL, Thrasher A, Etnoyer-Slaski JL, Cohen LL. Multimodal mechanical stimulation reduces acute and chronic low back pain: Pilot data from a HEAL phase 1 study. Front Pain Res (Lausanne). 2023 Apr 26;4:1114633. doi: 10.3389/fpain.2023.1114633. eCollection 2023.

    PMID: 37179530DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Amy Baxter
Organization
MMJ Labs
abaxter@mmjlabs.com
1 877 805 2899

Study Officials

  • Amy Baxter, MD

    MMJ Labs LLC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Consecutive low back pain patients were offered to try a new device and give feedback on a prototype. Once the feedback was obtained, the changes were incorporated into a production-ready model and re-evaluated.
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 31, 2020

Study Start

January 17, 2020

Primary Completion

January 20, 2021

Study Completion

February 18, 2021

Last Updated

October 21, 2022

Results First Posted

October 21, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
36 months after publication
Access Criteria
researchers providing approved methodologically sound proposals

Locations

US(1)