Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation

W

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

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.

Trial contacts and locations

0

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Central trial contact

Heidi J Ahonen, PhD; Abdullah A Mosabbir, PhD

Data sourced from clinicaltrials.gov

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