NCT04468516

Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Wilfrid Laurier University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Chronic back and neck pain is the most common chronic condition worldwide. Unfortunately, the current available treatment options are limited and largely unsuccessful, which is considered as one of the primary drivers for the high cost of back pain management. Systematic reviews show that the results of common treatments including pain medications, surgery, exercise and psychological therapies for back pain demonstrate inconsistent results and moderate improvement. Therefore, non-invasive adjunct therapies can be a useful addition to traditional back pain management. Focused vibroacoustic treatment for back and neck pain is a non-invasive procedure that applies low frequency sound waves to the spine (50Hz-110Hz), and has shown consistent and positive results in early clinical and animal studies. The goal of this project is to test vibroacoustic sound waves delivered to the spine in a double blind randomized controlled trial to demonstrate the efficacy of focused vibroacoustics in treating chronic back pain. Participants with back pain will be recruited and divided into a treatment and placebo group and will undergo treatment at a clinic over a one month period. Outcome measures will be collected before and after the intervention period. Placebo participants will be offered the full treatment without charge after the experiment is over.

Conditions

• Back Pain

Interventions

Type	Name	Description
DEVICE	KKT	Vibroacoustic sound waves applied focally.
DEVICE	sham KKT	sham KKT

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2020-07-13
• Last updated: 2022-06-06

Regulatory

• FDA-regulated device study