Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome

Shoulder Pain Clinical Trial

— FDM  

Official title:

Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03521778
• Other study ID #: JozefPilsudskiU
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2018
• Source: Józef Pilsudski University of Physical Education
• Contact: Adrian Rogala, MSc
• Phone: 537067960
• Email: adrian.kamil.rogala[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 31, 2020
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 86 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• Fascial Distortion Model
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.
• 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.
• Traditional physiotherapy
Patients will receive traditional physiotherapy: Exercises, laser treatment, magnetic field therapy, ultrasound treatment, light treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Józef Pilsudski University of Physical Education

References & Publications (19)

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. — View 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. — View 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. Review. — View Citation

Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4. — View 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. — View 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. Review. — View 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. Review. — View 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. Erratum in: Am J Ind Med 1996 Sep;30(3):372. — View Citation

Ingber DE, Wang N, Stamenovic D. Tensegrity, cellular biophysics, and the mechanics of living systems. Rep Prog Phys. 2014 Apr;77(4):046603. Review. — View Citation

Ingber DE. Tensegrity I. Cell structure and hierarchical systems biology. J Cell Sci. 2003 Apr 1;116(Pt 7):1157-73. Review. — View Citation

Jacobson JA. Shoulder US: anatomy, technique, and scanning pitfalls. Radiology. 2011 Jul;260(1):6-16. doi: 10.1148/radiol.11101082. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. Review. — View Citation

Tesarz J, Hoheisel U, Wiedenhöfer 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. — View 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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Complexity of the Tensegrity Structure for Dynamic Energy and Force Distribution of Cytoskeleton during Cell Spreading
•   Connective tissue mechanoreceptors. A wicket to change skeletal muscle tone.
•   Fascia, somatics, proprioception and improvement of motion precision
•   Fascia: The Tensional Network of the Human Body
•   Fascial Manipulation for Musculoskeletal Pain
•   Fascial plasticity - a new neurobiological explanation
•   Methodology for assessing the quality of life
•   Practical Manual of the Fascial Distortion Model