Treatment of Chronic Back Pain With Focused Vibroacoustic Stimulation
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Change in Neck Pain Disability Index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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:
- Researcher assigning participants to treatment and control groups: Dr. Abdullah Mosabbir.
- Researcher(s)/clinician(s) performing pre-treatment/post-treatment assessments: Dr. Aslam Khan, or a Clinician hired by KKT who is NOT doing #3.
- Researcher(s)/clinician(s) performing treatments or sham procedure: Dr. Peter Dyback, or a Clinician hired by KKT who is NOT doing #2.
- Researcher who will assemble these data, code it, and do the data analysis: Dr. Abdullah Mosabbir.
- Researchers who will supervise the design and ethical conduct of the study as well as data analysis: Dr. Heidi Ahonen and Dr. Quincy Almeida.
- Researchers whose role is conceptual: Dr.Karim Bayanzay, Dr. Lidan You, and Dr. Lee Bartel.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic low back pain with a disease duration of more than 3 months (further diagnostic results were not required)
- •Scored at least 4/10 in pain scale (VAS or Numerical)
- •Written consent
排除标准
- •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.
结局指标
主要结局
Change in Neck Pain Disability Index
时间窗: 1 month
Measures neck pain disability
Change from baseline of Visual Analog Scale for Pain
时间窗: 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
时间窗: 1 month
Measures back pain disability.
Change in baseline of EuroQol (EQ5D-5L) Questionnaire
时间窗: 1 month
Quality of Life Questionnaire
次要结局
- Change in Leg length(1 month)
- Change in Shoulder and Pelvis tilt(1 month)
- Change in Medication Dosage(1 month)
- Change in Palpatory tenderness of the spine(1 month)
- Change in Cervical range of motion(1 month)
研究者
Abdullah Mosabbir
Principal Site Investigator
Wilfrid Laurier University