Back Pain
Conditions
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.
Interventions
DEVICEKKT
Vibroacoustic sound waves applied focally.
DEVICEsham KKT
sham KKT
Sponsors
KKT International
Wilfrid Laurier University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
There are two groups (treatment and placebo). Participants will not know which group they are in until the end. Masking will be maintained by the following plan: 1. Researcher assigning participants to treatment and control groups: Dr. Abdullah Mosabbir. 2. Researcher(s)/clinician(s) performing pre-treatment/post-treatment assessments: Dr. Aslam Khan, or a Clinician hired by KKT who is NOT doing #3. 3. Researcher(s)/clinician(s) performing treatments or sham procedure: Dr. Peter Dyback, or a Clinician hired by KKT who is NOT doing #2. 4. Researcher who will assemble these data, code it, and do the data analysis: Dr. Abdullah Mosabbir. 5. Researchers who will supervise the design and ethical conduct of the study as well as data analysis: Dr. Heidi Ahonen and Dr. Quincy Almeida. 6. Researchers whose role is conceptual: Dr.Karim Bayanzay, Dr. Lidan You, and Dr. Lee Bartel.
Intervention model description
Parallel double blind randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of Visual Analog Scale for Pain | 1 month | A scale which measures the intensity of pain. Scored from 0 to 100. 0 means no pain, 100 means maximum pain. |
| Change from baseline of Roland Morris Disability Questionnaire | 1 month | Measures back pain disability. |
| Change in baseline of EuroQol (EQ5D-5L) Questionnaire | 1 month | Quality of Life Questionnaire |
| Change in Neck Pain Disability Index | 1 month | Measures neck pain disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Medication Dosage | 1 month | The assessor will ask what medications the participant is taking. They will record the drug and dosage. |
| Change in Palpatory tenderness of the spine | 1 month | The assessor will count and record the number of tender regions along the spine. |
| Change in Shoulder and Pelvis tilt | 1 month | Measured via calipers |
| Change in Leg length | 1 month | — |
| Change in Cervical range of motion | 1 month | — |
Contacts
Primary ContactAbdullah A Mosabbir, PhD
Backup ContactHeidi J Ahonen, PhD
Outcome results
None listed