Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain

Low Back Pain Clinical Trial

Official title:

Addressing Feasibility of the DuoTherm in Acute and Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494841
• Other study ID #: UsabilityDuoTherm
• Secondary ID: 4R44DA049631
• Status: Completed
• Phase: N/A
• Start date: January 17, 2020
• Est. completion date: February 18, 2021

Study information

• Verified date: October 2022
• Source: MMJ Labs LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 18, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Recurrent
• Low Back Sprain

Intervention

Device:
• Duotherm VibraCool Back Device
Low back plate belt with mechanicothermal and pressure intervention options.

Locations

Country	Name	City	State
United States	Sport and Spine Rehab Clinic	Rockville	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 (6)

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. — 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. Review. — 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

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. — 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation
Primary	Participants' Choice in Thermal Options	One of four options: hot, cold, none, both	30 minutes
Primary	Would You Recommend	Binary approval or disapproval of device	After 30 minutes
Secondary	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