Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome

NCT03521778 | Unknown

• 1 other identifier: JozefPilsudskiU
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Fascial Distortion Model group

EXPERIMENTAL

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

Other: Fascial Distortion Model

Mulligan Concept group

EXPERIMENTAL

Patients will receive manual treatment complies with Mulligan Concept method.

Other: Mulligan Concept

Traditional physiotherapy group

EXPERIMENTAL

Patients will receive traditional physiotherapy.

Other: Traditional physiotherapy

Interventions

Fascial Distortion Model OTHER

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.

Also known as: Manual treatment- Fascial Distortion Model

Fascial Distortion Model group

Mulligan Concept OTHER

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.

Also known as: Manual treatment- Mulligan Concept

Mulligan Concept group

Traditional physiotherapy OTHER

Patients will receive traditional physiotherapy: Exercises, laser treatment, magnetic field therapy, ultrasound treatment, light treatment

Traditional physiotherapy group

Eligibility Criteria

• Age: 40 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Józef Piłsudski University of Physical Education: lead

Related Publications (19)

• 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.

  PMID: 21839150 BACKGROUND

• 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.

  PMID: 24639633 BACKGROUND

• 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.

  PMID: 18952123 BACKGROUND

• 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.

  PMID: 22852442 BACKGROUND

• 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.

  PMID: 23801005 BACKGROUND

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

  PMID: 21697306 BACKGROUND

• 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.

  PMID: 28167173 BACKGROUND

• 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.

  PMID: 14435991 BACKGROUND

• 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.

  PMID: 19166469 BACKGROUND

• 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.

  PMID: 26311620 BACKGROUND

• 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.

  PMID: 21949456 BACKGROUND

• 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.

  PMID: 24695087 BACKGROUND

• 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.

  PMID: 12615960 BACKGROUND

• 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.

  PMID: 28083527 BACKGROUND

• 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.

  PMID: 22094195 BACKGROUND

• 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.

  PMID: 20149960 BACKGROUND

• 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.

  PMID: 8773720 BACKGROUND

• 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.

  PMID: 11382253 BACKGROUND

• Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.

  PMID: 3791738 BACKGROUND

Related Links

• Fascia: The Tensional Network of the Human Body
• Fascia, somatics, proprioception and improvement of motion precision
• Complexity of the Tensegrity Structure for Dynamic Energy and Force Distribution of Cytoskeleton during Cell Spreading
• Fascial plasticity - a new neurobiological explanation
• Methodology for assessing the quality of life

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bartosz Molik, Professor

  Józef Piłsudski University of Physical Education

  STUDY CHAIR

Central Study Contacts

Adrian Rogala, MSc

CONTACT

537067960; adrian.kamil.rogala@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: May 11, 2018
• Study Start: May 25, 2018
• Primary Completion: August 30, 2019
• Study Completion: December 31, 2020
• Last Updated: May 11, 2018

Record last verified: 2018-04