The Effectiveness of High-intensity Laser Therapy After Arthroscopic Shoulder Rotator Cuff Repair. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of high-intensity laser therapy (HILT) as an adjunct to conventional rehabilitation in patients undergoing arthroscopic rotator cuff repair.
Despite surgical repair, patients frequently experience postoperative pain, limited range of motion, and delayed functional recovery. Conventional physiotherapy represents the standard of care; however, additional strategies may be needed to optimize outcomes. High-intensity laser therapy has been proposed as a non-invasive intervention with potential analgesic and anti-inflammatory effects, but its effectiveness in the postoperative setting remains unclear.
Participants will be randomly allocated to one of two groups: an experimental group receiving HILT in addition to conventional physiotherapy, and a control group receiving sham laser therapy combined with the same rehabilitation program. Both groups will undergo standardized rehabilitation sessions including therapeutic exercise.
The primary outcome is pain intensity, measured using the Visual Analog Scale. Secondary outcomes include shoulder range of motion (active and passive), muscle strength, functional status assessed with the Constant-Murley Score, and patient-reported disability and quality of life measured using the Shoulder Pain and Disability Index and the Quick Disabilities of the Arm, Shoulder and Hand.
Assessments will be conducted at baseline (at the start of rehabilitation), during the intervention period after the fourth (T1), seventh (T2), and tenth (T3) physiotherapy sessions, and at follow-up at 4 months.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arthroscopic rotator cuff repair of one shoulder for partial or full-thickness tear
- •Willingness to provide written informed consent
- •Age between 30 and 70 years
- •Pain intensity greater than 40/100 on the Visual Analog Scale
排除标准
- •Psychiatric disorders
- •Cognitive impairment
- •Rheumatic diseases or Fibromyalgia
- •Vascular diseases
- •Neoplastic diseases
- •Infectious diseases
- •Neurological disorders
- •Hemophilia or bleeding diathesis
- •Use of anticoagulant therapy
- •Presence of a pacemaker
- •History of epileptic seizures
- •Pregnancy or breastfeeding
- •Skin lesions or abrasions at the laser application site
- •Known hypersensitivity to laser therapy or photosensitization
- •Use of photosensitizing medications
- •Tattoo in the treatment area
- •Steroid injections in the target area within the previous 2-3 weeks
- •Recent trauma or injury
- •Suspected conditions in which deep tissue heating is contraindicated
- •Use of analgesic or anti-inflammatory medications during the study period
- •Positive status for human immunodeficiency virus infection