Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation

Wilfrid Laurier University

Status: Not yet enrolling

Conditions: Back Pain

Treatments: Device: KKT; Device: sham KKT

Study type: Interventional

Funder types: Other

Identifiers

NCT04468516

10010563

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of chronic low back pain with a disease duration of more than 3 months (further diagnostic results were not required)
• Aged 18-75.
• Scored at least 4/10 in pain scale (VAS or Numerical)
• Written consent

Exclusion criteria

• Acute back pain (< 4 weeks)
• History of spinal or vertebral surgery
• History of any vertebral or spinal infection
• History of significant trauma related to the spine
• History of IV drug use
• History of malignancy
• Congenital deformation of the spine (except mild scoliosis or kyphosis)
• Pregnancy
• Previous KKT Treatment
• Undergoing concurrent treatment Unable to complete all 12 treatment sessions due to travel, distance or transportation issues, etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

Treatment

Experimental group

Description:

Intervention is applied to the C1 of the spine.

Treatment:

Device: KKT

Placebo

Placebo Comparator group

Description:

Intervention is applied in reduced intensity to the trapezius muscle.

Treatment:

Device: sham KKT

Waitlist period

No Intervention group

Description:

Participants will have a 1 month waitlist period where no intervention takes place.