Efficacy of 448kilohertz Capacitive Resistive Monopolar Radiofrequency Stimulation in Chronic Shoulder Pain: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Change from Baseline ultrasound imaging at 3 months
研究概览
简要总结
448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated. Current studies show promising results in different musculoskeletal disorders, however further studies with proper designs and conclusive findings are necessary.
详细描述
Shoulder pain is is one of the most common musculoskeletal disorders, presenting a high prevalence in primary care centers. Many factors have been proposed as the cause of pain, however it is still controversial and the same regarding the best treatment option.
Treatments throw different techniques have been investigated, showing a variety of results in terms of pain and sensitivity. However, the use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment is to be explored.
The hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the shoulder will produce better outcomes in terms of ultrasound assessment, strength, pain, sensitivity and range of movement, when compared to traditional methods used like manual therapy and/or exercise.
The stimulus will be carried out on the shoulder region (suprascapular, axillar, subscapular, long thoracic or pectoralis nerves) and the thoracic region. All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.
The outcome measures will be electromyography and dynamometry to measure strength and muscular activity. The movements required to the patient will be shoulder flexion, abduction, adduction, and extension.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To suffer from shoulder pain more than three months.
- •Men or women aged between 18 to 65 years;
- •Unilateral pain located in the anterior and/or lateral shoulder region;
- •2 out of 3 positive clinical tests (Hawkins-Kennedy; Jobe; Neer);
- •Pain with normal activity ≥ 4/10 on a visual analogue scale;
- •Nontraumatic onset of shoulder pain.
排除标准
- •History of significant shoulder trauma, such as fracture or ultrasonography-clinically suspected full thickness cuff tear, following the classification of Wiener and Seitz
- •Recent shoulder dislocation in the past two years
- •Systemic illnesses such as rheumatoid arthritis
- •Adhesive capsulitis of the shoulder
- •Shoulder pain originating from the neck or if there was a neurological impairment, osteoporosis, hemophilia and/or malignancies.
结局指标
主要结局
Change from Baseline ultrasound imaging at 3 months
时间窗: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Elastography
次要结局
- Electromyography(time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later))
- Autonomic Symptom Profile questionnaire (ASP)(time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later))
- Change from Baseline dynamometry at 3 months(time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later))
- Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at three months(time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later))
- Algometry(time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later))
- Heart rate variability (HRV)(time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later))
- Range of movement(time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later))
- Catastrophizing Scale questionnaire(time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later))
研究者
SANTIAGO NAVARRO LEDESMA
UNIVERSITY PROFESSOR
University of Malaga