Effectiveness of Instrument-assisted Soft-tissue mobilization versus Myofascial release on Pain and Morphological characteristics of thoracolumbar fascia in Mechanical low back pain
试验速览
- 阶段
- 不适用
- 状态
- Not Applicable
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Ultrasound imaging for comparing the morphological characteristics
研究概览
简要总结
This randomized clinical trial investigates whether IASTM or MFR is more effective in reducing pain and improving the morphological characteristics (thickness, echogenicity, deformation) of the thoracolumbar fascia in patients with chronic mechanical low back pain. The study addresses a research gap by using ultrasound imaging to assess fascia changes, which has not been clearly established in prior research.
Participants (aged 18–65 with MLBP for over 3 months) will be divided into an experimental group receiving IASTM and a control group receiving MFR. Outcomes will be measured through ultrasound imaging and pain/disability scales like the Numeric Pain Rating Scale and Oswestry Disability Index. Appropriate statistical tests will compare within and between-group effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults between 18 and 65 years Mechanical LBP of over 3 months duration with at least ½ of days with pain over the prior 6-months (Deyo et al., 2014) Able to understand study procedures and willing to sign an informed consent document Willing to forgo any manual therapy treatment for LBP for the initial 4-week study period Willing to forgo any manual therapy treatment for LBP, other than study treatments, during the 4-week treatment period.
排除标准
- •Chiropractic care or other manual therapy treatment within 90 days Necessary tissue layers could not be visualized with ultrasound imaging Body Weight above 350 lbs.
- •(158.76 kg), (safety limit for motorized table) Unable to tolerate or safely receive study procedures Condition identified requiring referral to another provider (e.g., suspected or confirmed abdominal aortic aneurysm, low back pain from suspected renal lithiasis) Unable or unwilling to comply with study procedures Current or planned pregnancy (self-reported) within the Study timeframe Prior surgery to the thoracolumbar region Needing a proxy Connective tissue disorder such as Marfan and Ehlers-Danlos syndrome.
结局指标
主要结局
Ultrasound imaging for comparing the morphological characteristics
时间窗: 4 weeks
次要结局
- Numeric Pain Rating Scale (11-point)(Pressure Pain Threshold (PPT))
研究者
Ali Hossain
Jashore University of Science and Technology