Comparative Effectiveness of High-Intensity Laser Therapy Versus Corticosteroid Injection Versus Manual Therapy, Each Combined With Standard Exercise, for Frozen Shoulder (Adhesive Capsulitis): 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
- 180
- 试验地点
- 1
- 主要终点
- Change in Shoulder Pain and Disability
研究概览
简要总结
This study compares three common treatments for frozen shoulder when added to a standard exercise program: High-Intensity Laser Therapy (HILT), a corticosteroid (steroid) injection into the shoulder joint, and hands-on manual therapy by a physical therapist. A fourth group will receive only the standard exercise program. The goal is to see which combination works best to reduce shoulder pain and improve shoulder function over 6 months. The main outcomes are changes in pain (VAS scale) and shoulder disability (SPADI questionnaire) at 12 weeks.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 70 years, inclusive. Clinical diagnosis of primary (idiopathic) frozen shoulder, defined by shoulder pain and ≥50% restriction in passive external rotation compared to the contralateral (unaffected) shoulder.
- •Symptom duration between 3 and 9 months. Average shoulder pain intensity ≥ 4 on a 10-cm Visual Analogue Scale (VAS) over the past week.
- •Normal or age-appropriate radiographic findings of the glenohumeral joint (ruling out significant arthritis, fractures, calcific tendinitis).
- •Willingness and ability to attend scheduled treatment/assessment sessions. Ability to understand study procedures and provide written informed consent.
排除标准
- •Secondary frozen shoulder (e.g., post-traumatic, post-surgical, related to systemic disease like diabetes - clarify if diabetes is excluded or just secondary FS from diabetes).
- •Clinical or imaging evidence of significant rotator cuff tear requiring specific management.
- •Radiographic evidence of moderate to severe glenohumeral osteoarthritis (e.g., Kellgren-Lawrence grade ≥ 3).
- •Previous surgery on the index shoulder. Significant neurological disorders affecting shoulder or upper extremity function (e.g., cervical radiculopathy, stroke).
- •Received a corticosteroid injection in the index shoulder within the past 3 months.
- •Known contraindications to corticosteroid injections (e.g., uncontrolled diabetes, allergy, local infection).
- •Known contraindications to High-Intensity Laser Therapy (e.g., active malignancy in the treatment area, photosensitivity, pacemaker over treatment area).
- •Current participation in another interventional clinical trial for shoulder pain.
研究组 & 干预措施
HILT + Standard Exercise
Participants receive High-Intensity Laser Therapy (HILT) 2 times/week for 6 weeks, plus the Standard Exercise Program.
干预措施: High-Intensity Laser Therapy (HILT) (Device)
HILT + Standard Exercise
Participants receive High-Intensity Laser Therapy (HILT) 2 times/week for 6 weeks, plus the Standard Exercise Program.
干预措施: Standard Exercise Program (Behavioral)
Corticosteroid Injection + Standard Exercise
Participants receive a single ultrasound-guided intra-articular corticosteroid injection at baseline, plus the Standard Exercise Program.
干预措施: Ultrasound-Guided Intra-articular Corticosteroid Injection (Drug)
Corticosteroid Injection + Standard Exercise
Participants receive a single ultrasound-guided intra-articular corticosteroid injection at baseline, plus the Standard Exercise Program.
干预措施: Standard Exercise Program (Behavioral)
Manual Therapy + Standard Exercise
Participants receive manual therapy 2 times/week for 6 weeks, plus the Standard Exercise Program.
干预措施: Manual Therapy (Behavioral)
Manual Therapy + Standard Exercise
Participants receive manual therapy 2 times/week for 6 weeks, plus the Standard Exercise Program.
干预措施: Standard Exercise Program (Behavioral)
Standard Exercise Alone
Participants receive the Standard Exercise Program only.
干预措施: Standard Exercise Program (Behavioral)
结局指标
主要结局
Change in Shoulder Pain and Disability
时间窗: Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)
Shoulder Pain and Disability Index (SPADI). Change from baseline in the total SPADI score. SPADI consists of 13 items assessing pain (5 items) and disability (8 items). Total score ranges from 0-100, with lower scores indicating less pain and disability.
Change in Shoulder Pain Intensity
时间窗: Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3)
Visual Analogue Scale (VAS) for Pain. Change from baseline in average shoulder pain over the past week, measured on a 10 cm horizontal VAS, where 0 cm = no pain and 10 cm = worst imaginable pain. Lower scores indicate less pain. MCID estimated at 1.4 cm.
次要结局
- Change in Passive Shoulder Range of Motion (ROM)(Baseline (T0), 6 weeks (T1), 12 weeks (T2), 6 months (T3))
- Patient Global Rating of Change(6 weeks (T1), 12 weeks (T2), 6 months (T3))
- Incidence of Adverse Events(Throughout study participation (up to 6 months))