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| ID | Type | Description | Link |
|---|---|---|---|
| 4R44DA049631 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Sport and Spine Rehab Clinical Research Foundation | OTHER |
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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.
To facilitate data collection of a short-term intervention, the investigators chose to enroll patients from a mixed physical therapy/chiropractic practice with demographic and economic diversity in the metro Washington area. The neuromodulatory device will have patient controlled frequencies at 50Hz, 100Hz, and 180Hz attached to a 12 x 22 cm metal plate ergonomically curved to fit the low back. The device will be wearable with a neoprene belt on both sides for patients to adjust pressure. The metal pocket in our device holds a 221g clay pack capable of being frozen to 15F or heated to 110F or patient tolerance, with 30 minute thermal capacity. A convenience sample of 10 patients at the clinic was invited to give feedback on the prototype device after informed consent. Changes suggested were incorporated and after informed consent a second group of ten gave will give feedback with the production-ready device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duotherm VibraCool Back Device | Device | Low back plate belt with mechanicothermal and pressure intervention options. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Pain Relief | 7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
Yes based on self-representation
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| Name | Affiliation | Role |
|---|---|---|
| Amy Baxter, MD | MMJ Labs LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sport and Spine Rehab Clinic | Rockville | Maryland | 20852 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28017184 | Background | 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. | |
| 30146045 | Background | 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. |
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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.
36 months after publication
researchers providing approved methodologically sound proposals
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| ID | Title | Description |
|---|---|---|
| FG000 | DuoTherm VibraCool Back Device | 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. Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DuoTherm VibraCool Back Device | 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. Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale (centimeters) | Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation |
|
4 hours
20 patients will be evaluated for adverse events, mortality, or other not serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DuoTherm VibraCool Back Device | 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. Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Baxter | MMJ Labs | 1 877 805 2899 | abaxter@mmjlabs.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2020 | Sep 23, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 11, 2020 | Oct 19, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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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.
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| 30445274 | Background | 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. |
| 30829735 | Background | 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. |
| 29122196 | Background | 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. |
| 31021972 | Background | 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. |
| 37179530 | Derived | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Participants' Choice in Thermal Options | One of four options: hot, cold, none, both | Posted | Count of Participants | Participants | 30 minutes |
|
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| Primary | Would You Recommend | Binary approval or disapproval of device | Posted | Count of Participants | Participants | After 30 minutes |
|
|
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| Secondary | Subjective Pain Relief | 7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study | Posted | Mean | Standard Deviation | score on a scale | 30 minutes |
|
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|
|
| Both |
|