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临床试验/NCT05001438
NCT05001438Unknown不适用

Aleatorized Prospective Study on the Eficacy of Movilization Under Anesthesia in Patients With Frozen Shoulder That Already Receive Treatment With Hidrodilatation.

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Shoulder Pain and Dissability Index

研究概览

简要总结

Hidrodilatation alone is as efective as Hidrodilatation + Movilization under anesthesia to treat the frozen shoulder

详细描述

"Frozen shoulder" disease is a pathological entity defined by the presence of a painful shoulder accompanied by restricted mobility. It affects 2% of the population with a slight predominance in women and the average age ranges between 40 and 60 years. The diagnosis of frozen shoulder is clinical and by exclusion; it presents with constant pain, especially at night, which increases on sudden mobilization, with restriction of at least two axes of shoulder mobility, especially external rotation and abduction.

The initial treatment of these patients is always conservative and consists of the association of pharmacological treatment (analgesics and anti-inflammatory drugs) together with a specific rehabilitation program. However, in many cases recovery is not complete and many patients require additional more invasive treatments.

Hydrodilation is a technique described in 1965 that consists of infiltrating 20-40 cc of serum into the glenohumeral joint to distend the joint capsule. In most cases, it is also associated with intra-articular corticosteroid and anesthetic infiltration to add an anti-inflammatory and anesthetic effect to joint distention. Several studies have shown good results with this treatment, however, many patients persist with pain and significant functional limitations despite this treatment.

Joint Mobilization Under general Anesthesia (MUA) is a more invasive alternative therapeutic technique that consists of a controlled mobilization under general anesthesia to break the synovial adhesions and the joint capsule, with the objective of increasing the range of motion. Several studies have evaluated the effectiveness and safety of this treatment, considered today a valid option for the treatment of frozen shoulder refractory to more conservative treatment.

Some studies have already compared the effectiveness of hydrodilatation with MUA as treatments for frozen shoulder. Jacob et al. demonstrated the same effectiveness between hydrodilatation and MUA, however, MUA reported a higher rate of iatrogenesis: hemarthrosis and lesions in the labrum, glenohumeral ligament or subscapularis ligament. However, there is no study evaluating the synergy of both techniques in the treatment of painful shoulder.

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
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with "frozen shoulder", defined as painful shoulder accompanied with a greater or lesser degree of restriction of mobility, especially in passive external rotation of at least 3 months of evolution. The diagnosis, according to the usual protocol of the unit, should include radiological images that rule out degenerative or necrotic pathology and the performance of an ultrasound or MRI to rule out associated pathology of the rotator cuff, which are already obtained in the usual clinical follow-up.
  • Failure of conservative treatment after a period of 3 months.
  • Acceptance and signature of informed consent.

排除标准

  • Known allergies to corticosteroids
  • Patients with frozen shoulder secondary to previous shoulder surgery.
  • High-risk patients in need of anticoagulant treatments.
  • Patients with previous shoulder fracture.
  • History of joint infection.
  • Active neoplastic process.
  • Associated rheumatic pathology.

结局指标

主要结局

Shoulder Pain and Dissability Index

时间窗: 1 year

13 items completed by the patient on shoulder pain and function. A score of 0 indicates best 100 indicates worst

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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