跳至主要内容
临床试验/NCT04578366
NCT04578366已完成不适用

Effects Of Extracorporeal Shockwave Therapy in Long-term Functional Outcomes of Shoulder Adhesive Capsulitis

Riphah International University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Constant Shoulder Score (CSS)

研究概览

简要总结

Adhesive capsulitis refers to the occurrence of pain and a gradual decline in the range of motion (ROM) due to slow increases in synovial hypertrophy and the adhesion between the synovial membrane and articular surface. It leads to the loss of flexibility and difficulties with the activities of daily living (ADLs) due to chronic inflammation accompanied by intra-articular fibrosis. The real cause of this syndrome is unknown but there are some predisposing factors involved such as synovial cell hyperplasia, fibrosis of the capsule due to cytokines or other inflammatory factors. In the current study investigator will compare the effects of Extracorporeal Shockwave Therapy (ESWT) along with conventional therapy to treat the adhesive capsulitis.

详细描述

This study will be a Randomized Controlled Trail conducted at Horizon hospital, Lahore. The study will be completed within the time duration of Six months. Consecutive sampling technique will be used to collect the data. The sample size of 44 patients will be taken in this study to find the effects of ESWT on pain, ROM, functional mobility. Patient will be divided into two groups. Group A will be treated with ESWT with conventional therapy and Group B will be treated with conventional therapy. Constant Shoulder Score (CSS) and the Oxford Shoulder Score (OSS) tools will be used to measure the outcomes of the study.

One session of treatment per week for four weeks will be given. Pretest, posttest at 4th week and followup of 24th weeks will be evaluated.

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
Single (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Relapsed or episode of pain score ≥5 at assessment with a past history of pain for at least 2 months.
  • ROM restriction (>75% ROM loss in ≥2 directions including abduction, flexion and external rotation)
  • No treatment other than analgesics with unresponsive ROM restriction for the past 2months.
  • Unwilling or waiting and did not undergo joint injection.

排除标准

  • bilateral shoulder involvement
  • History of previous surgery on the shoulder
  • Shoulder fracture
  • Glenohumeral or Acromioclavicular arthritis
  • Inflammatory disorders
  • Bleeding disorders
  • Diabetes mellitus
  • Presence of severe osteoporosis
  • Pulmonary diseases
  • Any neuromuscular disorders
  • Pregnancy
  • Implanted pacemaker

结局指标

主要结局

Constant Shoulder Score (CSS)

时间窗: 8 months

The functional outcome of shoulder. Grading the Constant Shoulder Score (Difference between normal and Abnormal Side) \>30 Poor 21-30 Fair 11-20 Good \<11 Excellent

Range of motion

时间窗: 8 months

Oxford Shoulder Score (OSS), increasing score shows improvement, decrease in scores shows deterioration.

次要结局

  • NPRS-numeric pain rating scale(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Extracorporeal Shockwave Therapy in Long-term... | 临床试验