Effects of Ischemic Compression and Low-Level Laser Therapy in Combination With Exercise Versus Exercise Alone in Managing Myofascial Low Back Pain: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pain Intensity Measured by Visual Analog Scale (VAS)
研究概览
简要总结
This randomized controlled study will compare the effects of ischemic compression combined with exercise, low-level laser therapy combined with exercise, and sham low-level laser therapy combined with exercise in adults with subacute or chronic myofascial low back pain. Participants will be assigned to one of three treatment groups. Outcomes will include pain intensity measured using the Visual Analog Scale (VAS), pressure pain threshold (PPT), and disability measured using the Oswestry Disability Index (ODI). Outcomes will be assessed at baseline, 3 weeks, 6 weeks, and at a 1-month follow-up.
详细描述
This study is a randomized controlled trial designed to evaluate and compare three physical therapy interventions for adults with subacute or chronic myofascial low back pain. Participants will be assigned to one of three groups: ischemic compression combined with exercise, low-level laser therapy combined with exercise, or sham low-level laser therapy combined with exercise. The study will evaluate changes in pain intensity, pressure pain threshold, and low back pain-related disability. Outcome measures will include the Visual Analog Scale (VAS), pressure pain threshold (PPT), and Oswestry Disability Index (ODI). Measurements will be obtained at baseline, after 3 weeks of treatment, after 6 weeks of treatment, and at a 1-month follow-up.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 years
- •Diagnosis of myofascial low back pain
- •Presence of active myofascial trigger point(s) in the lumbar region
- •Ability to understand and follow study procedures
- •Willingness to participate and provide written informed consent
排除标准
- •Pregnancy or lactation
- •Photosensitivity or known sensitivity to light-based therapy
- •Pacemaker use
- •Malignancy or suspected malignancy, particularly in the treatment area
- •Skin lesions, active infection, or open wounds in the lumbar treatment area
- •History of lumbar spine surgery or spinal fracture
- •Neurological disorders that may affect study participation or outcome assessment
- •Serious systemic disease that may interfere with participation or treatment safety
- •Current physical therapy treatment for low back pain
- •Corticosteroid injection within the previous 3 months
- •Any contraindication to low-level laser therapy or ischemic compression
研究组 & 干预措施
Ischemic Compression Plus Exercise
Participants assigned to this group will receive ischemic compression in combination with an exercise program.
干预措施: Ischemic Compression (Other)
Ischemic Compression Plus Exercise
Participants assigned to this group will receive ischemic compression in combination with an exercise program.
干预措施: Exercise Program (Other)
Low-Level Laser Therapy Plus Exercise
Participants assigned to this group will receive low-level laser therapy in combination with an exercise program.
干预措施: Low-Level Laser Therapy (Device)
Low-Level Laser Therapy Plus Exercise
Participants assigned to this group will receive low-level laser therapy in combination with an exercise program.
干预措施: Exercise Program (Other)
Sham Low-Level Laser Therapy + Exercise.
Participants assigned to this group will receive sham low-level laser therapy, with the laser device applied to identified lumbar myofascial trigger points in the same manner and for the same duration as active LLLT, but with no laser energy delivered, followed by the standardized therapeutic exercise program.
干预措施: Exercise Program (Other)
Sham Low-Level Laser Therapy + Exercise.
Participants assigned to this group will receive sham low-level laser therapy, with the laser device applied to identified lumbar myofascial trigger points in the same manner and for the same duration as active LLLT, but with no laser energy delivered, followed by the standardized therapeutic exercise program.
干预措施: Sham Low-Level Laser Therapy (Device)
结局指标
主要结局
Pain Intensity Measured by Visual Analog Scale (VAS)
时间窗: Baseline, 3 weeks, 6 weeks, and 1-month follow-up
Pain intensity will be assessed using the Visual Analog Scale (VAS), with scores ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Lower scores indicate less pain.
次要结局
- Functional Disability Measured by the Oswestry Disability Index (ODI)(Baseline, 3 weeks, 6 weeks, and 1-month follow-up)
- Pressure Pain Threshold (PPT)(Baseline, 3 weeks, 6 weeks, and 1-month follow-up)
- Global Rating of Change (GROC)(3 weeks, 6 weeks, and 1-month follow-up)