Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-01-01

Brief Summary

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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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Detailed Description

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Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel double blind randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Treatment

Intervention is applied to the C1 of the spine.

Group Type EXPERIMENTAL

KKT

Intervention Type DEVICE

Vibroacoustic sound waves applied focally.

Placebo

Intervention is applied in reduced intensity to the trapezius muscle.

Group Type PLACEBO_COMPARATOR

sham KKT

Intervention Type DEVICE

sham KKT

Waitlist period

Participants will have a 1 month waitlist period where no intervention takes place.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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KKT

Vibroacoustic sound waves applied focally.

Intervention Type DEVICE

sham KKT

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No