Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation

Not Applicable

• Conditions: Back Pain
• Interventions: Device: sham KKT; Device: KKT

• Registration Number: NCT04468516
• Lead Sponsor: Wilfrid Laurier University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-03
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-13
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-06
• Study Start: 2022-09-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	sham KKT	Intervention is applied in reduced intensity to the trapezius muscle.
Treatment	KKT	Intervention is applied to the C1 of the spine.

Primary Outcome Measures

Name	Time	Method
Change in Neck Pain Disability Index	1 month	Measures neck pain disability
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

Secondary Outcome Measures

Name	Time	Method
Change in Shoulder and Pelvis tilt	1 month	Measured via calipers
Change in Leg length	1 month
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 Cervical range of motion	1 month