Clinical trial NCT04468516: Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation
Official title: Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Back Pain
Lead sponsor: Wilfrid Laurier University
Sponsor class: OTHER
Collaborators: name: KKT International
First posted: 2020-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel double blind randomized controlled trial
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline of Visual Analog Scale for Pain
timeFrame: 1 month
measure: Change from baseline of Roland Morris Disability Questionnaire
timeFrame: 1 month
measure: Change in baseline of EuroQol (EQ5D-5L) Questionnaire
timeFrame: 1 month
measure: Change in Neck Pain Disability Index
timeFrame: 1 month
Secondary outcomes:
measure: Change in Medication Dosage
timeFrame: 1 month
measure: Change in Shoulder and Pelvis tilt
timeFrame: 1 month
measure: Change in Leg length
timeFrame: 1 month
measure: Change in Cervical range of motion
timeFrame: 1 month
measure: Change in Palpatory tenderness of the spine
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
citation: Desmoulin GT, Yasin NI, Chen DW. Spinal mechanisms of pain control. Clin J Pain. 2007 Sep;23(7):576-85. doi: 10.1097/AJP.0b013e3180e00eb8.
citation: Desmoulin GT, Hewitt CR, Hunter CJ. Disc strain and resulting positive mRNA expression from application of a noninvasive treatment. Spine (Phila Pa 1976). 2011 Jun 15;36(14):E921-8. doi: 10.1097/BRS.0b013e3181fd78b3.
citation: Desmoulin GT, Reno CR, Hunter CJ. Free axial vibrations at 0 to 200 Hz positively affect extracellular matrix messenger ribonucleic acid expression in bovine nucleus pulposi. Spine (Phila Pa 1976). 2010 Jul 1;35(15):1437-44. doi: 10.1097/BRS.0b013e3181c2a8ec.