The Effectiveness of High-intensity Laser Therapy on Post-surgical Rehabilitation: 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 total knee arthroplasty (TKA).
Persistent pain and functional limitations are common after TKA despite standard rehabilitation, highlighting the need for adjunctive therapies to optimize postoperative recovery. High-intensity laser therapy has been proposed as a non-invasive intervention with potential analgesic and anti-inflammatory effects; however, its effectiveness in this population 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 lasting 60 minutes, including 15 minutes of active or sham laser therapy and 45 minutes of conventional physiotherapy.
The primary outcome is postoperative pain. Secondary outcomes include joint swelling, range of motion, muscle strength, physical function, and quality of life.
Assessments will be conducted at baseline (preoperative), at 1 month after surgery (prior to the start of rehabilitation), during the rehabilitation program (after the fourth, seventh, and tenth physiotherapy sessions), and at 4 months postoperatively (follow-up).
A total of 46 participants (23 per group) will be enrolled in the study.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary unilateral total knee arthroplasty for primary knee osteoarthritis
- •Age between 50 and 80 years
- •Pain intensity greater than 30/100 on the Visual Analog Scale (VAS)
- •Ability and willingness to provide written informed consent
排除标准
- •Psychiatric disorders
- •Cognitive impairments
- •Previous major trauma or surgery involving the affected knee
- •Rheumatic diseases or fibromyalgia
- •Vascular diseases
- •Neoplastic diseases
- •Infectious diseases
- •Neurological disorders
- •Hemophilia or bleeding disorders
- •Current anticoagulant therapy
- •Presence of a pacemaker
- •History of epileptic seizures
- •Known hypersensitivity or contraindication to laser therapy
- •Suspected conditions in which tissue heating is contraindicated
- •Use of photosensitizing medications or known photosensitivity
- •Skin lesions or abrasions at the treatment site
- •Tattoos in the treatment area
- •Intra-articular steroid injections in the target knee within the previous 2-3 weeks
- •Recent significant trauma or injury
- •Use of anti-inflammatory or analgesic medications or other pain-relieving treatments (if not controlled or standardized)
- •Pregnancy or breastfeeding
- •Positive status for human immunodeficiency virus