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临床试验/NCT03521778
NCT03521778Unknown不适用

Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome

Józef Piłsudski University of Physical Education0 个研究点目标入组 90 人开始时间: 2018年5月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
主要终点
Change from baseline DASH Outcome Measure at 3 months

研究概览

简要总结

Relatively new method of diagnosing and treating dysfunction of the musculoskeletal system is Fascial Distortion Model. It is manual therapy developed by emergency physician and an osteopath Stephen P. Typaldos.

Disfunction are diagnosed based on verbal and physical descriptions, palpations, anamnesis. As a result of examination, It can be found one or more of six different distortions. The aim of the study is to examine the effectiveness of FDM manual therapy in comparison to manual therapy using the Mulligan Concept method and traditional physiotherapy in patients with shoulder dysfunction who have undergone previous rehabilitation and who have not achieved satisfactory results. Patients will receive five treatments with one day brake between each treatment. The patient's condition will be evaluated before the first treatment, two weeks after the last treatment, and also after three months. As a outcome of the occurring phenomenon, structural changes are planned at the level of the fascial system in the studied region. The obtained results may influence the current views on diseases of the musculoskeletal system, as well as on the method of diagnosing and treating shoulder joint dysfunction.

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
40 Years 至 86 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of dysfunction in the shoulder joint based on an orthopedic and/or physiotherapeutic examination confirmed by X-ray and ultrasound imaging,
  • patients undergoing prior rehabilitation / pharmacotherapy / surgical intervention without satisfactory results,
  • limitation of mobility and / or pain in the shoulder complex,

排除标准

  • coexistence of neoplastic diseases,
  • symptoms from the cervical spine
  • pregnancy,
  • aneurysms,
  • osteitis,
  • arthritis
  • deep veins thrombosis of upper limbs,
  • resignation from the study / therapy,
  • skin damage, hematomas.

研究组 & 干预措施

Fascial Distortion Model group

Experimental

Patients will receive manual treatment complies with Fascial Distortion Model method.

干预措施: Fascial Distortion Model (Other)

Mulligan Concept group

Experimental

Patients will receive manual treatment complies with Mulligan Concept method.

干预措施: Mulligan Concept (Other)

Traditional physiotherapy group

Experimental

Patients will receive traditional physiotherapy.

干预措施: Traditional physiotherapy (Other)

结局指标

主要结局

Change from baseline DASH Outcome Measure at 3 months

时间窗: 1'st day, 2 weeks after treatment, 3 months after treatment

The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. It helps describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time .The DASH is scored in 30 items from 1 to 5. Higher score means greater level of disability.

Change from baseline Constant-Murley Shoulder Outcome Score at 3 months

时间窗: 1'st day, 3 months after treatment

The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.\[1\] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher score, the higher the quality of the function.

Change from baseline Quality Of Life Questionnaire SF- 36v2 at 3 months

时间窗: 1'st day, 3 months after treatment

The SF-36 is a 36 item questionnaire that measures eight multi-item dimensions of health: physical functioning (10 items) social functioning (2 items) role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items), and general health perception (5 items).

Change from baseline Visual Analogue Scale at 3 months

时间窗: 1'st day, 3 months after treatment

Visual analogue scales (score 0-10) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid classification of symptom severity and disease control. The higher score, indicate greater level of pain.

次要结局

未报告次要终点

研究者

发起方
Józef Piłsudski University of Physical Education
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrian Rogala

PhD Student

Józef Piłsudski University of Physical Education

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