跳至主要内容
临床试验/NCT04241484
NCT04241484撤回不适用

Piezowave Myofascial Acoustic Compression Therapy on Lateral and Medial Tendinopathies

Johns Hopkins University0 个研究点开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Change in Function as demonstrated by Quick score

研究概览

简要总结

Within the outpatient rehabilitation clinic, therapists provide therapeutic interventions to treat patients with various tendinopathies, including lateral and medial epicondylosis. Current conservative treatment includes immobilization for forced rest of the inflamed tendons and muscles, as well as mobilizations to focus stimulation of synovial fluid, provide movement to nourish cartilage, promote periarticular extensibility, and provide sensory and proprioceptive input. Musculoskeletal disorders can accompany both local and referred pain patterns that need to be assessed and treated. When an acute trauma or repetitive micro-trauma occurs, that may result in decreased range of motion and increased pain causing the onset of weakness and function of the affected extremity. An alternative approach is through the provision of Piezowave Myofascial Acoustic Compression Therapy (MyACT), which provides mechanical stimuli delivery to improve circulation and provide relief of pain. The focused sound waves produced by the Piezowave MyACT device are classified by a pressure surge, which is followed by a drop in pressure and a brief negative pressure phase low energy/low pressure application. It is this transformation of mechanical stimuli into biochemical signals, or mechanotransduction, which yields the treatment of myofascial and musculoskeletal pain. There is currently limited research to support the benefit in regards to increased function and decreased pain when the Piezowave MyACT is used for the treatment of lateral and medial epicondylosis. Of the limited research available, treatment with non-invasive shock wave therapy, complications are low and effect is achieved in most cases within three to five sessions.

If Piezowave Myofascial Acoustic Compression Therapy (MyACT)) is applied as treatment for symptoms of lateral and medical elbow tendinopathies, then the patient will experience increased function demonstrated by Quick DASH (Disability of the Arm, Shoulder and Hand) score and decreased pain demonstrated by subjective reporting on the numeric pain rating scale.

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
None

入排标准

年龄范围
22 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Tendinopathy symptoms referred for occupational therapy by physician.
  • Positive provocation tests

排除标准

  • Contraindications for shock wave
  • Infections
  • Tumor tissue
  • Blood clotting disorder
  • Blood thinning medication use
  • Pregnancy
  • Lung tissue in focal area
  • Air-containing organs
  • Elbow fracture
  • History of corticosteroid injections less than eight weeks/two months, prior to initiation of occupation therapy treatment for lateral or medial epicondylosis. The goal would be to have elimination of any residual benefit from the injection.

结局指标

主要结局

Change in Function as demonstrated by Quick score

时间窗: The Quick score will be completed by the participant at the initial evaluation or session and repeated at visit 10 or at day 30 day post-intervention, which ever comes first.

The Quick (Disability of the Arm, Shoulder and Hand) score will assess participant report of function based on daily activities by creating an upper extremity functional score. There are 11 questions that ask the participant to rate their difficulty or limitations and pain in order to complete specific tasks. Each questions will ask the participant to select one of the five measures from no difficulty, not limited at all or none to unable, extreme and I can't sleep, with the latter of the measures indicating decreased upper extremity function. A maximum total score of 55 and minimum of 11.

次要结局

  • Change in Pain level as demonstrate by the numeric pain rating scale(The participant will be asked to report their pain will be completed by the participant at the initial evaluation or session and repeated at visit 10 or at day 30 day post-intervention, which ever comes first.)

研究者

申办方类型
Other
责任方
Sponsor

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