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| Name | Class |
|---|---|
| KKT International | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Intervention is applied to the C1 of the spine. |
|
| Placebo | Placebo Comparator | Intervention is applied in reduced intensity to the trapezius muscle. |
|
| Waitlist period | No Intervention | Participants will have a 1 month waitlist period where no intervention takes place. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KKT | Device | Vibroacoustic sound waves applied focally. |
| |
| sham KKT |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdullah A Mosabbir, PhD | Contact | 6477875430 | Abdullah.Mosabbir@kktspinetreatment.com | |
| Heidi J Ahonen, PhD | Contact | 519.884.0710 | x2431 | hahonen@wlu.ca |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17710007 | Background | 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. | |
| 21289569 | Background | 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. |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Parallel double blind randomized controlled trial
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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:
| Device |
sham KKT |
|
| 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 |
| 20386503 | Background | 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. |