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

Primary Purpose

Shoulder Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fascial Distortion Model
Mulligan Concept
Traditional physiotherapy
Sponsored by
Józef Piłsudski University of Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

40 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Fascial Distortion Model group

    Mulligan Concept group

    Traditional physiotherapy group

    Arm Description

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

    Patients will receive manual treatment complies with Mulligan Concept method.

    Patients will receive traditional physiotherapy.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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).
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 15, 2018
    Last Updated
    April 28, 2018
    Sponsor
    Józef Piłsudski University of Physical Education
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03521778
    Brief Title
    Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome
    Acronym
    FDM
    Official Title
    Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 25, 2018 (Anticipated)
    Primary Completion Date
    August 30, 2019 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Józef Piłsudski University of Physical Education

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fascial Distortion Model group
    Arm Type
    Experimental
    Arm Description
    Patients will receive manual treatment complies with Fascial Distortion Model method.
    Arm Title
    Mulligan Concept group
    Arm Type
    Experimental
    Arm Description
    Patients will receive manual treatment complies with Mulligan Concept method.
    Arm Title
    Traditional physiotherapy group
    Arm Type
    Experimental
    Arm Description
    Patients will receive traditional physiotherapy.
    Intervention Type
    Other
    Intervention Name(s)
    Fascial Distortion Model
    Other Intervention Name(s)
    Manual treatment- Fascial Distortion Model
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Mulligan Concept
    Other Intervention Name(s)
    Manual treatment- Mulligan Concept
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Traditional physiotherapy
    Intervention Description
    Patients will receive traditional physiotherapy: Exercises, laser treatment, magnetic field therapy, ultrasound treatment, light treatment
    Primary Outcome Measure Information:
    Title
    Change from baseline DASH Outcome Measure at 3 months
    Description
    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.
    Time Frame
    1'st day, 2 weeks after treatment, 3 months after treatment
    Title
    Change from baseline Constant-Murley Shoulder Outcome Score at 3 months
    Description
    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.
    Time Frame
    1'st day, 3 months after treatment
    Title
    Change from baseline Quality Of Life Questionnaire SF- 36v2 at 3 months
    Description
    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).
    Time Frame
    1'st day, 3 months after treatment
    Title
    Change from baseline Visual Analogue Scale at 3 months
    Description
    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.
    Time Frame
    1'st day, 3 months after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    86 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adrian Rogala, MSc
    Phone
    537067960
    Ext
    +48
    Email
    adrian.kamil.rogala@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bartosz Molik, Professor
    Organizational Affiliation
    Józef Piłsudski University of Physical Education
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    21839150
    Citation
    Tesarz J, Hoheisel U, Wiedenhofer B, Mense S. Sensory innervation of the thoracolumbar fascia in rats and humans. Neuroscience. 2011 Oct 27;194:302-8. doi: 10.1016/j.neuroscience.2011.07.066. Epub 2011 Aug 2.
    Results Reference
    background
    PubMed Identifier
    24639633
    Citation
    Liljencrantz J, Olausson H. Tactile C fibers and their contributions to pleasant sensations and to tactile allodynia. Front Behav Neurosci. 2014 Mar 6;8:37. doi: 10.3389/fnbeh.2014.00037. eCollection 2014.
    Results Reference
    background
    PubMed Identifier
    18952123
    Citation
    Olausson H, Wessberg J, Morrison I, McGlone F, Vallbo A. The neurophysiology of unmyelinated tactile afferents. Neurosci Biobehav Rev. 2010 Feb;34(2):185-91. doi: 10.1016/j.neubiorev.2008.09.011. Epub 2008 Oct 8.
    Results Reference
    background
    PubMed Identifier
    22852442
    Citation
    Stecco C, Macchi V, Porzionato A, Duparc F, De Caro R. The fascia: the forgotten structure. Ital J Anat Embryol. 2011;116(3):127-38.
    Results Reference
    background
    PubMed Identifier
    23801005
    Citation
    Stecco A, Gesi M, Stecco C, Stern R. Fascial components of the myofascial pain syndrome. Curr Pain Headache Rep. 2013 Aug;17(8):352. doi: 10.1007/s11916-013-0352-9.
    Results Reference
    background
    PubMed Identifier
    21697306
    Citation
    Jacobson JA. Shoulder US: anatomy, technique, and scanning pitfalls. Radiology. 2011 Jul;260(1):6-16. doi: 10.1148/radiol.11101082.
    Results Reference
    background
    PubMed Identifier
    28167173
    Citation
    Adstrum S, Hedley G, Schleip R, Stecco C, Yucesoy CA. Defining the fascial system. J Bodyw Mov Ther. 2017 Jan;21(1):173-177. doi: 10.1016/j.jbmt.2016.11.003. Epub 2016 Nov 16.
    Results Reference
    background
    PubMed Identifier
    14435991
    Citation
    RALSTON HJ 3rd, MILLER MR, KASAHARA M. Nerve endings in human fasciae, tendons, ligaments, periosteum, and joint synovial membrane. Anat Rec. 1960 Feb;136:137-47. doi: 10.1002/ar.1091360208. No abstract available.
    Results Reference
    background
    PubMed Identifier
    19166469
    Citation
    Benjamin M. The fascia of the limbs and back--a review. J Anat. 2009 Jan;214(1):1-18. doi: 10.1111/j.1469-7580.2008.01011.x.
    Results Reference
    background
    PubMed Identifier
    26311620
    Citation
    Dawidowicz J, Szotek S, Matysiak N, Mielanczyk L, Maksymowicz K. Electron microscopy of human fascia lata: focus on telocytes. J Cell Mol Med. 2015 Oct;19(10):2500-6. doi: 10.1111/jcmm.12665. Epub 2015 Aug 27.
    Results Reference
    background
    PubMed Identifier
    21949456
    Citation
    Gillies AR, Lieber RL. Structure and function of the skeletal muscle extracellular matrix. Muscle Nerve. 2011 Sep;44(3):318-31. doi: 10.1002/mus.22094.
    Results Reference
    background
    PubMed Identifier
    24695087
    Citation
    Ingber DE, Wang N, Stamenovic D. Tensegrity, cellular biophysics, and the mechanics of living systems. Rep Prog Phys. 2014 Apr;77(4):046603. doi: 10.1088/0034-4885/77/4/046603.
    Results Reference
    background
    PubMed Identifier
    12615960
    Citation
    Ingber DE. Tensegrity I. Cell structure and hierarchical systems biology. J Cell Sci. 2003 Apr 1;116(Pt 7):1157-73. doi: 10.1242/jcs.00359.
    Results Reference
    background
    PubMed Identifier
    28083527
    Citation
    Najrana T, Sanchez-Esteban J. Mechanotransduction as an Adaptation to Gravity. Front Pediatr. 2016 Dec 26;4:140. doi: 10.3389/fped.2016.00140. eCollection 2016.
    Results Reference
    background
    PubMed Identifier
    22094195
    Citation
    Giamberardino MA, Affaitati G, Fabrizio A, Costantini R. Myofascial pain syndromes and their evaluation. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):185-98. doi: 10.1016/j.berh.2011.01.002.
    Results Reference
    background
    PubMed Identifier
    20149960
    Citation
    Yung E, Asavasopon S, Godges JJ. Screening for head, neck, and shoulder pathology in patients with upper extremity signs and symptoms. J Hand Ther. 2010 Apr-Jun;23(2):173-85; quiz 186. doi: 10.1016/j.jht.2009.11.004. Epub 2010 Feb 11.
    Results Reference
    background
    PubMed Identifier
    8773720
    Citation
    Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L. Erratum In: Am J Ind Med 1996 Sep;30(3):372.
    Results Reference
    background
    PubMed Identifier
    11382253
    Citation
    Beaton DE, Katz JN, Fossel AH, Wright JG, Tarasuk V, Bombardier C. Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. J Hand Ther. 2001 Apr-Jun;14(2):128-46.
    Results Reference
    background
    PubMed Identifier
    3791738
    Citation
    Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
    Results Reference
    background
    Links:
    URL
    https://www.kobo.com/us/en/ebook/fascia-the-tensional-network-of-the-human-body
    Description
    Fascia: The Tensional Network of the Human Body
    URL
    http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0014392
    Description
    Complexity of the Tensegrity Structure for Dynamic Energy and Force Distribution of Cytoskeleton during Cell Spreading
    URL
    https://pdfs.semanticscholar.org/4fa0/f27447715ca65e5237eea7d9473dfd14945d.pdf
    Description
    Fascial plasticity - a new neurobiological explanation
    URL
    http://www.ptfarm.pl/pub/File/Farmacja%20Polska/2009/08-2009/10%20%20QOL.pdf
    Description
    Methodology for assessing the quality of life

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    Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome

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