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
- 1
- 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
研究组 & 干预措施
High-Intensity Laser Therapy (HILT) Group
Participants in the HILT group will receive an 8-week course of High-Intensity Laser Therapy (HILT) for the treatment of sacroiliitis. HILT will be administered using a Class IV laser with a wavelength of 980 nm, power output of 10 W, spot size of 0.5 cm, and a dose of 60 J/cm2 per session. The laser will be applied to the affected area of the sacroiliac joint, with the aim of achieving a sensation of warmth in the region. The treatment sessions will be delivered for 10 minutes per session, with a total of 12 sessions over 8 weeks. Participants will receive no other specific interventions during the study period.
干预措施: High-Intensity Laser Therapy (HILT) (Device)
Sham-Control Group
Participants in the sham-control group will receive a sham HILT treatment for the treatment of sacroiliitis. The sham treatment will be delivered using a device that looks like the HILT device, but does not emit laser energy. The device will be applied to the affected area of the sacroiliac joint, with the aim of achieving a sensation of warmth in the region. The treatment sessions will be delivered for 10 minutes per session, with a total of 12 sessions over 8 weeks. Participants will receive no other specific interventions during the study period.
干预措施: Sham High-Intensity Laser Therapy (HILT) (Device)
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