Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation

NCT04468516 | Unknown FDA Device

• 1 other identifier: 10010563
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Change in Medication Dosage

  1 month

• Change in Shoulder and Pelvis tilt

  1 month

• Change in Leg length

  1 month

• Change in Cervical range of motion

  1 month

• Change in Palpatory tenderness of the spine

  1 month

Study Arms (3)

Treatment

EXPERIMENTAL

Intervention is applied to the C1 of the spine.

Device: KKT

Placebo

PLACEBO COMPARATOR

Intervention is applied in reduced intensity to the trapezius muscle.

Device: sham KKT

Waitlist period

NO INTERVENTION

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

Interventions

KKT DEVICE

Vibroacoustic sound waves applied focally.

Treatment

sham KKT DEVICE

sham KKT

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wilfrid Laurier University: lead
• KKT International: collaborator

Related Publications (3)

• 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.

  PMID: 17710007 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.

  PMID: 21289569 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.

  PMID: 20386503 BACKGROUND

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Abdullah A Mosabbir, PhD

CONTACT

6477875430; Abdullah.Mosabbir@kktspinetreatment.com

Heidi J Ahonen, PhD

CONTACT

519.884.0710; hahonen@wlu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Site Investigator

Model Details: Parallel double blind randomized controlled trial

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 13, 2020
• Study Start: September 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share