Treatment Using 448 kHz Capacitive Resistive Monopolar Radiofrequency in Patients With Subacromial Syndrome. A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
The purpose of this study is to assess the effectiveness of 448 kHz capacitive resistive monopolar radiofrequency in the treatment of subacromial syndrome.
详细描述
Shoulder pain has a high prevalence in our society, several studies estimate an annual prevalence between 5% and 47%. It is one of the main causes of musculoskeletal pain, particularly in third place, after the low back pain and neck pain.
Symptoms of pathologies of subacromial syndrome, where, regardless of origin, pain is the number one symptom for the patient, which emanates functional impairment and the impact on quality of life.
Among the non-pharmacological treatments of subacromial syndrome, a systematic review concludes that the first line of intervention should be a therapeutic exercise program. In many cases, this is usually accompanied by the application of electrophysical agents (short wave, laser, etc.). A recent study has shown that the application of Short Wave Radio Frequency improved pain in people with subacromial syndrome. The current frequency that is applied in the short wave is 27.12 MHz, however, there are other relatively new forms of radiofrequency in which a frequency less than 1 MHz is used. These are beginning to be used in clinical practice and recently have shown positive results related to pain and functionality of musculoskeletal pathologies such as knee osteoarthritis. In these two clinical trials, what is called Resistive Capacitive Monopolar Radio Frequency (RFCR) was used, the frequency of which was 448 KHz and 485KHz respectively, much lower than the frequency used in Shortwave. The RFCR has a potential advantage since it is applied with electrodes directly on the skin and is not transmitted in the air unlike the Short Wave.
Based on the few clinical trials in people with pathology and the physiological effects evidenced in healthy people and in vitro preclinical studies, it is considered pertinent to carry out the present investigation.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Patients between 18 and 70 years years old with diagnosis of subacromial syndrome
- •Visual Analogue Scale (VAS) less than or equal to
- •Positive Neer and Hawkins test.
排除标准
- •Clinical examination compatible with complete rotator cuff tear (Drop-arm positive test)
- •Fibromyalgia
- •Adhesive capsulitis
- •Be receiving physiotherapeutic treatment or have received it previously for this pathology one month before the start of treatment.
- •Patients with alterations of thermal sensitivity.
- •Derived from the absolute and relative contraindications of CRMRF:
- •Pacemaker
- •Thrombophlebitis
- •Pregnancy
- •Skin disorders (recent wounds or burns)
结局指标
主要结局
Visual Analogue Scale
时间窗: 3 months after the end of the intervention
minimun 0 - maximun10. Higher scores mean a worse outcome
SPADI
时间窗: 3 months after the end of the intervention
Shoulder Pain and Disabilty Index
次要结局
- European Quality ol life - 5 dimensions (EQ-5D)(3 months after the end of the intervention)
- Quick DASH(3 months after the end of the intervention)
- PPT(After 3 weeks)
