Evaluation of the Efficacy of B-Cure Laser Treatment on Pain and Functionality Following Arthroscopic Rotator Cuff Repair: A Prospective Double Blind, Randomized, Sham-Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change from baseline in level of pain by VAS
研究概览
简要总结
Rehabilitation following rotator cuff surgery is characterized with high levels of pain, limited range of motion, and decreased quality of life. The purpose of this study is to evaluate the B-Cure laser photobiomodulation home-use device in addition to standard care, for the reduction of pain, increase in functionality, and improvement of life quality during rehabilitation following rotator cuff arthroscopic surgery.
详细描述
Patients planned to undergo rotator cuff arthroscopy will be randomized to receive active or sham devices for self-application at home in addition to standard care. Patients will be invited to up to 5 visits at the clinic: baseline (before surgery), post-operative day 1, and 1, 3, and optionally 6 months after surgery. Evaluations will include physical examination, physical activity tests, range of motion measurements, Constant score, thermal imaging, and patient reported outcomes including subjective pain level by visual analogue scale, functional and quality of life questionnaires.
The study hypothesis is that B-Cure laser treatments, applied, at home, by the patient, can reduce pain and accelerate healing over standard care thereby improving the rehabilitation process following rotator cuff arthroscopic surgery.
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)
盲法说明
Sham control
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-65
- •Men or women
- •Full or partial rotator cuff tear
- •Scheduled to undergo RCAS because of failure of conservative therapy (injections, medication, physiotherapy)
- •Is willing to perform the full protocol
- •Voluntarily sign and date an informed consent form
- •Be able to understand and complete the various questionnaires
排除标准
- •Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits
- •Participation in another clinical study within 30 days before screening
- •Scheduled to undergo an elective medical procedure during the study timeframe that will interfere with the study as deemed by the PI
- •Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for shoulder pain
- •Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light
- •Has osteoarthritis
- •Other chronic pain conditions: fibromyalgia, failed back surgery, back pain
- •Avascular necrosis
- •Rheumatoid arthritis
- •Psychiatric disorders including major depression, schizophrenia, bipolar disease
研究组 & 干预措施
Standard + B-Cure Pro
Subjects from the Standard + B-Cure Pro group will receive standard care and in addition will self-treat at home with the B-Cure device
干预措施: B-Cure Pro (Device)
Standard + Sham
Subjects from the Standard + Sham group will receive standard care and in addition will self-treat at home with the sham B-Cure device
干预措施: Sham (Device)
结局指标
主要结局
Change from baseline in level of pain by VAS
时间窗: 1 month post-surgery
Subject assessment of pain will be evaluated using a Visual Analogue Scale (VAS), were 0 is "no pain" and 100 is "intolerable pain".
次要结局
- Change from baseline in functionality (CONSTANT score)(1 month post-surgery)