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Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome (FDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03521778
Recruitment Status : Not yet recruiting
First Posted : May 10, 2018
Last Update Posted : May 10, 2018
Information provided by (Responsible Party):
Adrian Rogala, Józef Piłsudski University of Physical Education

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Other: Fascial Distortion Model Other: Mulligan Concept Other: Traditional physiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome
Estimated Study Start Date : May 25, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Fascial Distortion Model group
Patients will receive manual treatment complies with Fascial Distortion Model method.
Other: Fascial Distortion Model

Patients will receive manual treatment according to FDM procedures:

  1. Triggerbands - therapist put a pressure by the thumb along the presented pathway.
  2. Continuum Distortions - therapist put a pressure by the thumb at the exact place of feeling of pain.
  3. Folding Distortions - therapist conduct traction or compression of the affected joint.
  4. Herniated Triggerpoint - therapist put a pressure by the thumb at the place where HTP occurs.
  5. Cylinder Distortions - therapist compress and stretch by the hands affected area.
  6. Tectonic Fixation - Therapist compress and stretch affected area by the hands or tools like vacuum bubble.
Other Name: Manual treatment- Fascial Distortion Model

Experimental: Mulligan Concept group
Patients will receive manual treatment complies with Mulligan Concept method.
Other: Mulligan Concept

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.

Other Name: Manual treatment- Mulligan Concept

Experimental: Traditional physiotherapy group
Patients will receive traditional physiotherapy.
Other: Traditional physiotherapy

Patients will receive traditional physiotherapy:

Exercises, laser treatment, magnetic field therapy, ultrasound treatment, light treatment

Primary Outcome Measures :
  1. Change from baseline DASH Outcome Measure at 3 months [ Time Frame: 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.

  2. Change from baseline Constant-Murley Shoulder Outcome Score at 3 months [ Time Frame: 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.

  3. Change from baseline Quality Of Life Questionnaire SF- 36v2 at 3 months [ Time Frame: 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).

  4. Change from baseline Visual Analogue Scale at 3 months [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03521778

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Contact: Adrian Rogala, MSc 537067960 ext +48

Sponsors and Collaborators
Józef Piłsudski University of Physical Education
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Study Chair: Bartosz Molik, Professor Józef Piłsudski University of Physical Education

Additional Information:

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Responsible Party: Adrian Rogala, PhD Student, Józef Piłsudski University of Physical Education Identifier: NCT03521778     History of Changes
Other Study ID Numbers: JozefPilsudskiU
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Signs and Symptoms