Efficacy of High-Intensity Laser Therapy in Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Pain Intensity (Visual Analog Scale, VAS)
研究概览
简要总结
Greater Trochanteric Pain Syndrome (GTPS) is a common cause of lateral hip pain that can significantly impair daily activities and quality of life. Conservative treatments, including physical therapy modalities and injections, are considered first-line management.
High-Intensity Laser Therapy (HILT) is a non-invasive modality with greater tissue penetration compared to low-level laser therapy and has shown promising results in musculoskeletal disorders; however, evidence in GTPS is limited.
This study aims to evaluate the efficacy of HILT compared with a sham intervention in patients with GTPS, focusing on pain intensity, functional status, and quality of life.
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)
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 to 80 years
- •Patients diagnosed with Greater Trochanteric Pain Syndrome (GTPS) based on clinical examination
- •Presence of symptoms for at least 3 months
- •Pain intensity ≥4 on the Visual Analog Scale (VAS)
- •No corticosteroid injection or other conservative treatment within the last 3 months
排除标准
- •Hip fracture, tumor, infection, or advanced osteoarthritis
- •Contraindications to high-intensity laser therapy (e.g., pacemaker, pregnancy, coagulation disorders, anticoagulant therapy, neoplasia, history of epilepsy)
- •Contraindications to physical activity (e.g., ischemic heart disease, arrhythmia, uncontrolled hypertension, heart failure, severe respiratory insufficiency)
- •Peripheral vascular disorders (e.g., thrombophlebitis, thrombosis, lymphedema)
- •History of trauma within the last 3 months or prior surgery involving the lower extremity or lumbar spine
- •Neurological disorders or chronic inflammatory diseases
研究组 & 干预措施
High-Intensity Laser Therapy (HILT) + Exercise
Participants will receive high-intensity laser therapy (HILT) in addition to a standardized home exercise program. The exercise program will include hip strengthening, stretching, and movement control exercises targeting the gluteal muscles and peri-trochanteric soft tissues. HILT will be applied to the greater trochanteric region over 10 treatment sessions (5 sessions per week for 2 consecutive weeks) using a standardized treatment protocol.
干预措施: High-Intensity Laser Therapy (HILT) (Device)
Sham Laser + Exercise (Control Group)
Participants will receive the same standardized home exercise program as the intervention group. In addition, a sham laser treatment will be applied using the same device and treatment setup without delivering therapeutic laser energy. The number and frequency of sessions will be identical to the active treatment group to ensure blinding.
干预措施: Sham Laser (Device)
结局指标
主要结局
Pain Intensity (Visual Analog Scale, VAS)
时间窗: Baseline (T0), 2 weeks (end of the treatment period; T1), and 8 weeks after treatment completion (T2).
Pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.
次要结局
- Pressure Pain Threshold (Algometry)(Baseline (T0), 2 weeks (end of the treatment period; T1), and 8 weeks after treatment completion (T2).)
- Lower Extremity Functional Scale (LEFS)(Baseline (T0), 2 weeks (end of the treatment period; T1), and 8 weeks after treatment completion (T2).)
- Roles and Maudsley Score (RMS)(2 weeks (end of the treatment period; T1), and 8 weeks after treatment completion (T2).)
- Single-Leg Stance Test(Baseline (T0), 2 weeks (end of the treatment period; T1), and 8 weeks after treatment completion (T2).)
研究者
Gizem Suna Tuncer
Principal Investigator, Physical Medicine and Rehabilitation Specialist
Ankara Etlik City Hospital