Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome

Conditions
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Shoulder Pain

Intervention / Treatment
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* Other: Fascial Distortion Model
* Other: Mulligan Concept
* Other: Traditional physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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, Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fascial Distortion Model group<br>Patients will receive manual treatment complies with Fascial Distortion Model method. | Other: Fascial Distortion Model<br>* Patients will receive manual treatment according to FDM procedures: Triggerbands - therapist put a pressure by the thumb along the presented pathway. Continuum Distortions - therapist put a pressure by the thumb at the exact place of feeling of pain. Folding Distortions - therapist conduct traction or compression of the affected joint. Herniated Triggerpoint - therapist put a pressure by the thumb at the place where HTP occurs. Cylinder Distortions - therapist compress and stretch by the hands affected area. Tectonic Fixation - Therapist compress and stretch affected area by the hands or tools like vacuum bubble.<br>* Other names: Manual treatment- Fascial Distortion Model;|
| Experimental: Mulligan Concept group<br>Patients will receive manual treatment complies with Mulligan Concept method. | Other: Mulligan Concept<br>* Patients will receive manual treatment according to Mulligan Concept procedures: MWM- Mobilization With Movement- application can be defined as the application of a sustained passive force/glide. NAG - Natural Apophyseal Glide - application can be defined as the oscillatory mobilization techniques from the middle to the end of the range of motion. SNAG- Sustained Natural Apophyseal Glide- They are weight bearing techniques: all procedures are done with the patient sitting or in standing. They are mobilisations with active movement followed by passive over pressure.<br>* Other names: Manual treatment- Mulligan Concept;|
| Experimental: Traditional physiotherapy group<br>Patients will receive traditional physiotherapy. | Other: Traditional physiotherapy<br>* Patients will receive traditional physiotherapy: Exercises, laser treatment, magnetic field therapy, ultrasound treatment, light treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline DASH Outcome Measure at 3 months | 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. | 1'st day, 2 weeks after treatment, 3 months after treatment | 
| Change from baseline Constant-Murley Shoulder Outcome Score at 3 months | 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. | 1'st day, 3 months after treatment | 
| Change from baseline Quality Of Life Questionnaire SF- 36v2 at 3 months | 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). | 1'st day, 3 months after treatment | 
| Change from baseline Visual Analogue Scale at 3 months | 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. | 1'st day, 3 months after treatment |