Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation

Conditions
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Back Pain

Intervention / Treatment
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* Device: KKT
* Device: sham KKT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel double blind randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Intervention is applied to the C1 of the spine. | Device: KKT<br>* Vibroacoustic sound waves applied focally.<br>|
| Placebo Comparator: Placebo<br>Intervention is applied in reduced intensity to the trapezius muscle. | Device: sham KKT<br>* sham KKT<br>|
| No Intervention: Waitlist period<br>Participants will have a 1 month waitlist period where no intervention takes place. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Visual Analog Scale for Pain | A scale which measures the intensity of pain. Scored from 0 to 100. 0 means no pain, 100 means maximum pain. | 1 month | 
| Change from baseline of Roland Morris Disability Questionnaire | Measures back pain disability. | 1 month | 
| Change in baseline of EuroQol (EQ5D-5L) Questionnaire | Quality of Life Questionnaire | 1 month | 
| Change in Neck Pain Disability Index | Measures neck pain disability | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Medication Dosage | The assessor will ask what medications the participant is taking. They will record the drug and dosage. | 1 month | 
| Change in Shoulder and Pelvis tilt | Measured via calipers | 1 month | 
| Change in Leg length |  | 1 month | 
| Change in Cervical range of motion |  | 1 month | 
| Change in Palpatory tenderness of the spine | The assessor will count and record the number of tender regions along the spine. | 1 month |