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
About this trial
This is an interventional treatment trial for Shoulder Pain
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.
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
NCT ID
NCT03521778
First Posted
April 15, 2018
Last Updated
April 28, 2018
Sponsor
Józef Piłsudski University of Physical Education
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
Learn more about this trial
Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome
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