Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Back Pain
• Intervention / Treatment: Device: KKT; Device: sham KKT

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdullah A Mosabbir, PhD; Phone Number: 6477875430; Email: Abdullah.Mosabbir@kktspinetreatment.com
• Study Contact Backup: Name: Heidi J Ahonen, PhD; Phone Number: x2431 519.884.0710; Email: hahonen@wlu.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wilfrid Laurier University
• Collaborators: KKT International

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 10010563

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No