The Effects of CureWave Laser on Paraspinal Muscle Oxygenation, Pressure Pain Thresholds, Muscle Edema, Muscle Quality, and Perceived Outcomes in Patients With Chronic Low Back Pain.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- CHANGE in Muscle sensitivity
研究概览
简要总结
The purpose of this study is to evaluate the effects of CureWave laser on paraspinal muscle oxygenation, pressure pain thresholds, muscle edema, and quality, and perceived outcomes in patients with chronic low back pain.
详细描述
Low back pain (LBP) contributes to disability and has a significant economic impact. High intensity laser devices are class 4 producing > 40 W of power at longer wavelengths, thereby allowing deeper tissue penetration. Currently, there is little evidence to demonstrate the effectiveness of high intensity laser treatment in those with chronic LBP. Optimal dosing strategies are still unknown as well as patient response based on chronicity of symptoms. Therefore, our study seeks to evaluate the effectives of high intensity laser therapy using CureWave in those with LBP of a duration longer than 3 months and with a dosing strategy of two times/week for three weeks.
Hypothesis
- CureWave laser therapy will increase total oxygenated hemoglobin and muscle blood flow in patients with chronic LBP.
- CureWave laser therapy will reduce inflammation as assessed by muscle edema in patients with chronic LBP.
- CureWave laser therapy will improve paraspinal echogenicity (muscle quality) following treatment in patients with chronic LBP.
- CureWave laser therapy will decrease muscle sensitivity in patients with chronic LBP
- CureWave laser therapy will demonstrate improve patient reported outcomes, including decreased pain, reduced disability and improved function in patients with chronic LBP.
- CureWave laser therapy will increase muscle activation during maximal strength testing.
- CureWave laser therapy will decrease performance fatigability as assessed by maximal muscle activation and force production.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participating subjects will be blinded to group assignment. Also, the outcomes assessor analyzing the data will be blinded to group assignment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Self-reported history of low back pain (5 episodes in lifetime or 3 in last three years which altered activities of daily living)13
排除标准
- •Self-reported pregnancy
- •Inability to complete all required meeting sessions
- •Known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease
- •Regularly uses prescription medication
- •Seeking medical care for the current episode of low back pain
- •Report average symptoms greater than 8/10
- •Inability to perceive light touch.
- •Verbal reports of known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease
- •Verbal reports of known skin sensitivity to gels or adhesives.
结局指标
主要结局
CHANGE in Muscle sensitivity
时间窗: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Muscle sensitivity will be measured with a handheld digital algometer (Wagner FDX-25 pressure algometer- Wagner Instruments, Greenwich, CT) and be applied at a right angle to the skin surface with the subject lying in prone position at 3 locations on the Paravertebral muscles, Quadratus lumborum, and Piriformis. Pressure will be applied at a rate of 30 kPa/s, which corresponds to 3 N/s.
CHANGE in Numeric Pain Rating Scale
时间窗: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Quantity of perceived Pain will be evaluated via a likert scale between 0 (no pain) to 10 (the worst imaginable pain)
CHANGE in Muscle Edema
时间窗: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Muscle edema will be assessed via ultrasound using the echo intensity function. Ultrasound images will be obtained using a portable brightness mode (B-mode) ultrasound-imaging device (GE Logiqe, USA) and a multi-frequency linear-array probe (12L-Rs; 5-13MHz; 38.4 mm field-of-view). Ultrasound images will be analyzed using ImageJ software (Version 1.47v., National Institutes of Health, Bethesda, MD, USA). Echo intensity, as assessed by gray-scale analysis (0 arbitrary units \[AU\], corresponds to black image, 255 AU corresponds to white image) will be performed using the histogram function and will be determined from the same region of interest as muscle thickness.
CHANGE in total hemoglobin
时间窗: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Change in total hemoglobin will be used as an index of change in regional blood volume.will be assessed using near-infrared spectroscopy (NIRS) (Portamon, Artinis Medical Systems, Arnhem, The Netherlands).
CHANGE in EMG activity of the lumbar paraspinal muscles
时间窗: Baseline; 24-48 hours after baseline; 4 weeks after baseline
EMG will be recorded during all submaximal and maximal strength testing. EMG will be assessed using wireless Bluetooth electrodes that will be attached using double-sided adhesive stickers. All submaximal and maximal strength testing will be performed using a hand-held dynamometer (Microfet 2 Manual Muscle Tester). Subjects will be stabilized using a nylon strap, the same material and mechanism as a seat belt, when necessary to eliminate accessory or compensatory motion during strength testing. This will be placed on their anterior and/or medial thigh with padding to eliminate any discomfort where the strap contacts the skin.
CHANGE in Muscle Oxygenation
时间窗: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Muscle oxygenation will be assessed using near-infrared spectroscopy (NIRS) (Portamon, Artinis Medical Systems, Arnhem, The Netherlands). Changes in muscle tissue oxygenation and deoxyhemoglobin will be examined across time using the optical densities from two continuous wavelengths (760 and 850 nm)
次要结局
- CHANGE in Sleep disturbance (short form 8a)(Baseline; 24-48 hours after baseline; 4 weeks after baseline)
- CHANGE in International Physical Activity Questionnaire (IPAQ)(Baseline; 24-48 hours after baseline; 4 weeks after baseline)
- CHANGE in McGill Pain Questionnaire(Baseline; 24-48 hours after baseline; 4 weeks after baseline)
- CHANGE in Oswestry Disability Index(Baseline; 24-48 hours after baseline; 4 weeks after baseline)
- CHANGE in Patients Specific Functional Scale(Baseline; 24-48 hours after baseline; 4 weeks after baseline)
- CHANGE in Global Rating of Change(Baseline; 24-48 hours after baseline; 4 weeks after baseline)