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临床试验/NCT02971215
NCT02971215已完成不适用

Effectiveness of High Intensity Laser Therapy in the Treatment of Subacromial Impingement Syndrome

University of Castilla-La Mancha2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
2
主要终点
Shoulder Pain and Disability Index (SPADI)

研究概览

简要总结

The purpose of this study is to assess the effectiveness of high intensity laser therapy in the treatment of subacromial impingement 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 space impingement 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. Because of the need to implement research to assess the effectiveness of high intensity laser therapy with new studies mayor methodological quality of obtaining conclusive results, and based on the scientific evidence supporting the low-power laser therapy as a useful tool in addressing the shoulder tendon pathology, we consider very interesting the realization of this research project.

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)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18 and 75 years old with diagnosis of subacromial impingement syndrome or any of the pathologies that compose it (tendinosis-tendinitis supraspinatus and rest of the rotator cuff, subacromial bursitis and tendinitis of the long head of the biceps).
  • Visual Analogue Scale (VAS) less than or equal to
  • Forward flexion at least of 100º

排除标准

  • Calcific tendinitis
  • Complete rupture of the rotator cuff.
  • Adhesive capsulitis.
  • Clinical history of pathologies that without affecting the shoulder joint refer to painful shoulder symptoms (cervical root involvement, cervical surgery, cervical osteoarthritis and neurological pathologies)
  • Fibromyalgia
  • 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 Laser Therapy:
  • Photosensitive patients
  • Neoplastic processes
  • Hyperthyroidism
  • Pregnancy
  • Patients with a history of epileptic seizures

研究组 & 干预措施

High-intensity laser therapy

Experimental

High-intensity laser therapy application through iLux Laser device

干预措施: iLux Laser (Device)

Sham device

Sham Comparator

Sham high-intensity laser therapy application through sham iLux Laser device

干预措施: Sham ilux Laser (Device)

结局指标

主要结局

Shoulder Pain and Disability Index (SPADI)

时间窗: three months after the end of the protocol treatment

SPADI test

Constant-Murley Score

时间窗: three months after the end of the protocol treatment

Constant-Murley Score without strength section. The results will be expressed on a maximum of 75 points.

Quick-Dash Abbreviated

时间窗: three months after the end of the protocol treatment

Quick- Dash Abbreviated test

次要结局

  • Painful pressure threshold after first session(First session - 15 minutes after laser or sham treatment.)
  • Painful pressure threshold(Baseline, at the of the 15 sessions, one month after the end of the protocol treatment, three months after the end of the protocol treatment)
  • VAS(Baseline, at the of the 15 sessions, one month after the end of the protocol treatment, three months after the end of the protocol treatment)

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Sponsor

研究点 (2)

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