The Effectiveness of High-Intensity Laser Therapy in Reducing Pain and Improving Function in Patients With Sacroiliitis: A Sham-Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Changes in Pain intensity
研究概览
简要总结
To investigate the effectiveness of High-Intensity Laser Therapy (HILT) in reducing pain and improving function in patients with sacroiliitis, aged 40-60 years.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Triple blinded
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Adults aged 40-60 years old
- •Diagnosis: Confirmed diagnosis of sacroiliitis by a specialist (e.g., rheumatologist, orthopedic surgeon, or radiologist) based on a combination of clinical findings, laboratory tests, and imaging studies
- •Clinical findings: Presence of at least one or more of the following clinical signs and symptoms suggestive of sacroiliitis:
- •Low back pain, buttock pain, or hip pain, worsened by prolonged sitting, standing, or walking
- •Stiffness in the lower back, buttock, or hip region, particularly in the morning or following prolonged inactivity
- •Pain improvement with physical activity or exercise
- •Duration of symptoms: Experiencing symptoms for at least 3 months
排除标准
- •Previous surgery or invasive procedures targeting the sacroiliac joints
- •Contraindications to physical interventions (e.g., spinal instability, fractures, or severe neurological deficits)
- •Presence of other spinal pathologies or systemic inflammatory conditions that could confound the assessment of sacroiliitis (e.g., lumbar disc herniation, ankylosing spondylitis, or rheumatoid arthritis)
- •Pregnant or breastfeeding women
结局指标
主要结局
Changes in Pain intensity
时间窗: Changes in Pain intensity Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
The Numeric Pain Rating Scale is a self-reported measure of pain intensity, with a score ranging from 0 (no pain) to 10 (worst pain imaginable). Participants will be asked to rate their pain intensity at rest and during movement of the sacroiliac joint.
Changes in Functional ability
时间窗: Changes in Functional ability Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
The Oswestry Disability Index is a self-reported measure of functional ability, with a score ranging from 0% (no disability) to 100% (maximum disability). Participants will be asked to complete a questionnaire assessing their ability to perform various activities of daily living, such as walking, sitting, and standing.
次要结局
- Changes in Range of Motion in the Lumbopelvic Region (Modified Schober Test and Hip Flexion/Extension)(Changes in Range of Motion Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up))
- Changes in Health-Related Quality of Life (Short Form 36 Health Survey)(Changes in Health-Related Quality of Life Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up))
- Global Perceived Effect (Global Perceived Effect Scale)(Measured at week 8 and week 12 (follow-up))
研究者
Mohamed Magdy ElMeligie
Lecturer of Physical Therapy and Director of Electromyography Lab
Ahram Canadian University