Quantum Spectrum Radiation Emitter for Adhesive Capsulitis (Frozen Shoulder or Stiff Painful Shoulder): a Prospective, Self-controlled Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- self-reported pain and function scores
研究概览
简要总结
This is a prospective, self-controlled study to evaluate the efficacy of the Quantum spectrum radiation emitter for adhesive capsulitis.
详细描述
Adhesive capsulitis (also termed frozen shoulder, stiff painful shoulder, or periarthritis) is a common cause of shoulder pain estimated to affect 2-5% of the general population.
The disorder is characterized by spontaneous onset of shoulder pain and progressive global stiffness of the glenohumeral joint accompanied by significant disability. Most studies have suggested a self-limiting condition lasting an average of two to three years, although significant numbers of people have residual clinically detectable restriction of movement beyond three years, and smaller numbers have residual disability.
Many interventions have been advocated for the treatment of adhesive capsulitis, although only limited data from randomised controlled trials are available. In addition, there are not enough data to either support or refute the efficacy of any of the commonly used interventions for this condition, including non-steroidal anti-inflammatory drugs, corticosteroid injections, and physiotherapy. Oral steroids were first advocated in the 1950s, with claims that they expedited recovery and reduced the need for manipulation under anaesthesia. However, these medications are associated with many adverse reactions.
The aims of this study are to determine whether three weeks' treatment with quantum spectrum radiation emitter in patients with adhesive capsulitis is effective for improving pain, function, and range of motion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ability to provide written informed consent
- •over 18 years old
- •with pain and stiffness in one shoulder predominantly for three weeks or more
- •restriction of passive motion in at least one shoulder by more than 30˚ in two or more planes of movement, measured at the time of the onset of pain with a gravity inclinometer.
排除标准
- •hypertensive patients
- •patients with cardiac arrhythmias
- •patients with epilepsy
- •patients with pacemakers, hearing aids or other electronic components
- •pregnant patients
- •patients with radiological evidence of osteoarthritis of the shoulder or fracture;calcification about the shoulder joint;reason to suspect a complete rotator cuff tear (weakness of arm elevation, a positive"drop arm sign", a high riding humerus visible on X ray of the shoulder or demonstration of a complete rotator cuff tear on ultrasound)
- •patients likely not to comply with follow up (for example, living too far away to attend for follow-up assessment, or indicating they would be unable or unwilling to attend for outcome assessment)
- •patients without written informed consent.
结局指标
主要结局
self-reported pain and function scores
时间窗: at first day and 3 weeks
Participants' overall assessment of pain, night pain, and activity related pain are each measured using a vertical Likert scale labelled"no pain"( = 0) at the bottom and"maximum imaginable pain"( = 10) at the top.
Croft score
时间窗: at first day and 3 weeks
The Croft shoulder disability questionnaire are recorded as a yes or a no, and the number of positive responses is summated to give a score out of 22.
Range of active motion
时间窗: at first day and 3 weeks
A standardised protocol is used to measure active total shoulder flexion and abduction.
The shoulder pain and disability index
时间窗: at first day and 3 weeks
The shoulder pain and disability index (SPADI) is calculated by summing and then averaging the items of the two subscales.
DASH score
时间窗: at first day and 3 weeks
The"disabilities arm shoulder and hand"(DASH) questionnaire has 30 items relating to functional activities and symptoms.
Participant-rated improvement
时间窗: at first day and 3 weeks
Participant-rated improvement using a five point categorical scale (marked improvement, moderate improvement, the same, moderate worsening, marked worsening).
次要结局
- SF-36(at first day and 3 weeks)
- The health assessment questionnaire(at baseline and three weeks)