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临床试验/NCT03185078
NCT03185078已完成不适用

Effect of Different Doses of Extracorporeal Shock Wave Therapy on Diabetes Related Frozen Shoulder

Okan University2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2019年1月25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
39
试验地点
2
主要终点
SPADI

研究概览

简要总结

The aim of this study is to observe the changes in the combined ESWT application and physiotherapy program in the frozen shoulder pathology associated with diabetes. Different treatment approaches will try to identify the most effective treatment method. Changes in muscle tone, pain, range of motion and functionallity will be observed with ESWT treatment. For the first time placebo-controlled research is being conducted with different doses of ESWT in our country and in the World literature. In this way the lower floor of the further work to be done will be established.

详细描述

The study will be performed with participants who has diabetic frozen shoulder diagnosis after clinical examination and imaging procedures performed, held at Okan University Hospital, Physical Therapy and Rehabilitation Clinic. Data will be recorded with the shoulder evaluation form in the study and cases will be divided into three groups with simple randomization method. The initial range of motion of the participants will be evaluated bilaterally using an electro-goniometer. The muscle tone evaluation will be made with MyotonPro. Muscle strength assessment will be performed with the MicroFET2 dynamometer at the appropriate measurement positions. Participants' pain assessment will be done in the rest, activity and night pain using the Visual Analog Scale. The Shoulder Pain Disability Scale will be used to assess participants' shoulder function. The short-form-36 questionnaire will be used evaluating the quality of life. Physiotherapy application will be applied to all three groups in the form of standard treatment protocol, duration and number. For the first group ESWT application will be done at energy density of 0.12 mJ/mm2, in the second group, at an energy density of 0.3 mJ/mm2, for the third group application will be done as sham ESWT. The ESWT will be administered once a week and in two separate sessions of 2000 strokes. After initial measurements, re-evaluations will be done in the fourth and sixth weeks. The statistics will be analyzed by appropriate methods.

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
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sex: No limit on eligibility based on the sex of participants.
  • Gender: Eligibility is not based on gender.
  • Age Limits:
  • Minimum Age: 30 years Maximum Age: 65
  • Inclusion Criteria:
  • Pain in the shoulder joint longer than for six weeks The shoulder joint movements of cases at least two of the abduction, flexion, external rotation, and internal rotation movements with a limitation of motion > 50% Differentiated from other pathologies according to shoulder MRI results

排除标准

  • Limitation of pain due to cervical radiculopathy Rotator cuff massive tears Recurrent subluxation Trauma or patients with active infection Using cardiac pills, patients Blood coagulation disorders Neurologic causes-restriction of movement in shoulder joint due to cerebrovascular pathologies, Limitation of movement due to rheumatic causes
  • Sampling Method: Simple random sampling

研究组 & 干预措施

Active Comparator: Low density ESWT Application

Experimental

ESWT application will be done at energy density of 0.12 mJ/mm2.

干预措施: Extracorporeal Shock Wave Therapy (Device)

Active Comparator: Low density ESWT Application

Experimental

ESWT application will be done at energy density of 0.12 mJ/mm2.

干预措施: Placebo ESWT (Other)

Active Comparator: High density ESWT Application

Experimental

ESWT application will be done at an energy density of 0.3 mJ/mm2.

干预措施: Extracorporeal Shock Wave Therapy (Device)

Active Comparator: High density ESWT Application

Experimental

ESWT application will be done at an energy density of 0.3 mJ/mm2.

干预措施: Placebo ESWT (Other)

Control

Sham Comparator

The ESWT application will be executed when the ESWT application is in the off position. During application, pre-recorded sound beats will be played to the treatment group.

干预措施: Placebo ESWT (Other)

结局指标

主要结局

SPADI

时间窗: Change from baseline shoulder functionality, at the 4th week and at the 6th week.

The Shoulder Pain and Disability Index. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.

VAS

时间窗: Change will be assessed about pain, at the 4th week and at the 6th week from baseline

Visual Analog Scale In the study, the chart on the 10 cm length of the diseased pain 0: painless; 10: It was told that it was unbearable pain. Patients were asked to mark the appropriate interval for their pain. The point marked by the patient was measured and recorded with the aid of a ruler

次要结局

未报告次要终点

研究者

发起方
Okan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tülay Çevik

PT, MSc

Okan University

研究点 (2)

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