Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation

Back Pain Clinical Trial

Official title:

Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04468516
• Other study ID #: 10010563
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: June 2022
• Source: Wilfrid Laurier University
• Contact: Abdullah A Mosabbir, PhD
• Phone: 6477875430
• Email: Abdullah.Mosabbir[@]kktspinetreatment.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain

Intervention

Device:
• KKT
Vibroacoustic sound waves applied focally.
• sham KKT
sham KKT

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wilfrid Laurier University	KKT International

References & Publications (3)

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. — View 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. — View Citation

Desmoulin GT, Yasin NI, Chen DW. Spinal mechanisms of pain control. Clin J Pain. 2007 Sep;23(7):576-85. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline of Roland Morris Disability Questionnaire	Measures back pain disability.	1 month
Primary	Change in baseline of EuroQol (EQ5D-5L) Questionnaire	Quality of Life Questionnaire	1 month
Primary	Change in Neck Pain Disability Index	Measures neck pain disability	1 month
Secondary	Change in Medication Dosage	The assessor will ask what medications the participant is taking. They will record the drug and dosage.	1 month
Secondary	Change in Shoulder and Pelvis tilt	Measured via calipers	1 month
Secondary	Change in Leg length		1 month
Secondary	Change in Cervical range of motion		1 month
Secondary	Change in Palpatory tenderness of the spine	The assessor will count and record the number of tender regions along the spine.	1 month