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| ID | Type | Description | Link |
|---|---|---|---|
| 4R44DA049631-02 | U.S. NIH Grant/Contract | View source | |
| R44DA058952 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Sport and Spine Rehab Clinical Research Foundation | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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Evaluate the difference in opioid use, pain intensity and pain interference in patients with moderate to severe low back pain using DuoTherm multimodal harmonic mechanical stimulation (M-Stim) unit compared to Transcutaneous Electrical Nerve Stimulation (TENS)
160 patients with acute or exacerbations of chronic low back pain (LBP) presenting for chiropractic and rehabilitation care will be randomized to one of two conditions: an M-Stim pain relief belt device incorporating 8 patterns of vibration motors (and optional heat, cold, and pressure) delivered through a sculpted metal plate; or a 4-lead TENS unit with 8 channels of stimulation and adjustable intensity. Patients will be blinded to the hypothesis-driving intervention. They will be prompted daily by a Qualtrics text link to a secure data recording site collecting analgesic use and treatments, including opioid brand, dose, pill number, and source, and pain data, then weekly for 3 months (acute pain) or 6 months (chronic).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal Harmonic Mechanical Stimulation Neuromodulation Wearable Belt (M-Stim) | Experimental | DuoTherm is a novel multimodal low back pain relief device incorporating 8 harmonic vibration patterns of mechanical stimulation (M-Stim) including neuromodulatory frequencies, 5 intensity levels, and optional heat, cold, and 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 at least daily for 30 minutes. |
|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Active Comparator | A prescription 4-lead 8-channel TENS unit (LG Smart) with variable intensity settings. Patients will be instructed to use the TENS at least daily for 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M-Stim | Device | The casing for the device is a 54" belt with 3-button haptic controller for on-off, therapy cycles(8) and intensity(5) levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid initiation in the opioid-naive | New opioid prescriptions for subjects without history of opioids for LBP | All opioid diaries for 3 months |
| Opioid use in prior users | Change in milligram morphine equivalents (MME) reported daily | 28 days (duration of daily recording) |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use Risk Factors in the Opioid-Naive | The difference in opioid use days, MME, and those using opioids more than 7 days after presentation | All opioid diaries for 3 months |
| Opioid use in those with more severe pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jena Slaski | Sport and Spine Clinical Research Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sport and Spine Rehab Clinics | Landover | Maryland | 20785 | United States | ||
| Kaizo Health Fairfax |
| 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. | |
| 25639530 | Background | 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. |
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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 access, data requestors will need to sign a data access agreement.
up to 36 months after publication of results
researchers providing approved methodologically sound proposals
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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 | Jul 13, 2023 | Feb 23, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 13, 2022 | Sep 26, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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A randomized, double-blind controlled trial with 3- (aLBP) or 6- month (cLPB) follow-up.
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Participants were blinded to which device powered the study hypothesis, and blinded to their assigned intervention until after documenting initial NRS pain intensity. The protocol statistician and study coordinator knew device assignments and had access to data, but did not conduct analysis. The PI and treating chiropractor were blinded to allocation and all data during enrollment, with the PI accessing data only after study completion. The analyzing statisticians were blinded to device assignment until completion of analysis. Success of participant blinding was tested with prompts, "select if you received… control or treatment" and "How confident are you?"
|
| TENS | Device | 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. |
|
|
Opioid use days in those with the NIH Research Taskforce severity of moderate to severe in M-Stim versus TENS
| All opioid diaries for 6 months |
| Opioid prescribing compared to a contemporaneous national LPB prescribing of 25% | New opioid prescription rate for each intervention compared to nationally prevalent prescribing rates of 25% with moderate to severe pain in outpatient settings | All opioid diaries for 6 months |
| Fairfax |
| Virginia |
| 22030 |
| United States |
| 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. |
| 22588748 | Background | 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. |
| 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. |
| 16437495 | Background | 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. |
| 27033320 | Background | 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. |
| 12638100 | Background | 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. |
| 33870150 | Background | Delitto A, Patterson CG, Stevans JM, Freburger JK, Khoja SS, Schneider MJ, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Beneciuk JM, George SZ, Saper RB. Stratified care to prevent chronic low back pain in high-risk patients: The TARGET trial. A multi-site pragmatic cluster randomized trial. EClinicalMedicine. 2021 Mar 30;34:100795. doi: 10.1016/j.eclinm.2021.100795. eCollection 2021 Apr. |
| 27484682 | Background | Deyo RA, Hallvik SE, Hildebran C, Marino M, Dexter E, Irvine JM, O'Kane N, Van Otterloo J, Wright DA, Leichtling G, Millet LM. Association Between Initial Opioid Prescribing Patterns and Subsequent Long-Term Use Among Opioid-Naive Patients: A Statewide Retrospective Cohort Study. J Gen Intern Med. 2017 Jan;32(1):21-27. doi: 10.1007/s11606-016-3810-3. Epub 2016 Aug 2. |
| 32947539 | Background | Hayden JA, Ellis J, Asbridge M, Ogilvie R, Merdad R, Grant DAG, Stewart SA, Campbell S. Prolonged opioid use among opioid-naive individuals after prescription for nonspecific low back pain in the emergency department. Pain. 2021 Mar 1;162(3):740-748. doi: 10.1097/j.pain.0000000000002075. |
| 37179530 | Background | 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. |
| 40709052 | Derived | Baxter AL, Etnoyer-Slaski JL, Williams JAR, Swartout K, Cohen LL, Lawson ML. Preventing opioid prescribing for low back pain using multimodal mechanical stimulation vs. TENS: a randomized-controlled trial. Front Pain Res (Lausanne). 2025 Jul 10;6:1612572. doi: 10.3389/fpain.2025.1612572. eCollection 2025. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |