Shoulder PainFDMNCT03521778
Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome
A study testing Fascial Distortion Model, Mulligan Concept and Traditional physiotherapy in people with Shoulder Pain, run by Józef Piłsudski University of Physical Education.
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. Read more about this study
- Who is it for?
- Ages 40 to 86 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Fascial Distortion Model, Mulligan Concept and Traditional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- coexistence of neoplastic diseases,
- symptoms from the cervical spine
- pregnancy,
- aneurysms,
- osteitis,
- arthritis
Show all 9Show fewer
- deep veins thrombosis of upper limbs,
- resignation from the study / therapy,
- skin damage, hematomas.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Fascial Distortion Model, Mulligan Concept, Traditional physiotherapy
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial Distortion ModelOther
Also called Manual treatment- 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 ConceptOther
Also called Manual treatment- 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 physiotherapyOther
Patients will receive traditional physiotherapy:
Exercises, laser treatment, magnetic field therapy, ultrasound treatment, light treatment
| Study group | Role | What they receive |
|---|---|---|
| Fascial Distortion Model group | Experimental | Patients will receive manual treatment complies with Fascial Distortion Model method. Receives: Other: Fascial Distortion Model |
| Mulligan Concept group | Experimental | Patients will receive manual treatment complies with Mulligan Concept method. Receives: Other: Mulligan Concept |
| Traditional physiotherapy group | Experimental | Patients will receive traditional physiotherapy. Receives: Other: Traditional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 1'st day, 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start25 May 2018 (estimated)
- Primary completion30 Aug 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Rogala, Józef Piłsudski University of Physical Education
- Investigators
- Bartosz Molik, Professor, Study chair, Józef Piłsudski University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521778
- Sponsor's protocol ID
- JozefPilsudskiU
- Acronym
- FDM
- Status last verified
- Apr 2018
- First submitted
- 15 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21839150Liljencrantz 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.
PubMed 24639633Olausson 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.
PubMed 18952123Stecco C, Macchi V, Porzionato A, Duparc F, De Caro R. The fascia: the forgotten structure. Ital J Anat Embryol. 2011;116(3):127-38.
PubMed 22852442Stecco 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.
PubMed 23801005Jacobson JA. Shoulder US: anatomy, technique, and scanning pitfalls. Radiology. 2011 Jul;260(1):6-16. doi: 10.1148/radiol.11101082.
PubMed 21697306Adstrum 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.
PubMed 28167173RALSTON 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.
PubMed 14435991Benjamin 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.
PubMed 19166469Dawidowicz 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.
PubMed 26311620Gillies 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.
PubMed 21949456Ingber 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.
PubMed 24695087Ingber DE; New Collective Author. Tensegrity I. Cell structure and hierarchical systems biology. J Cell Sci. 2003 Apr 1;116(Pt 7):1157-73. doi: 10.1242/jcs.00359.
PubMed 12615960Najrana 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.
PubMed 28083527Giamberardino 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.
PubMed 22094195
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome
- ClinicalTrials.gov ID
- NCT03521778
- Acronym / sponsor ID
- FDM / JozefPilsudskiU
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- 25 May 2018 (estimated)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fascial Distortion Model group | Experimental | Other: Fascial Distortion ModelPatients will receive manual treatment complies with Fascial Distortion Model method. |
| Mulligan Concept group | Experimental | Other: Mulligan ConceptPatients will receive manual treatment complies with Mulligan Concept method. |
| Traditional physiotherapy group | Experimental | Other: Traditional physiotherapyPatients will receive traditional physiotherapy. |
Who may qualify
- Ages
- 40 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (9 listed)
- coexistence of neoplastic diseases,
- symptoms from the cervical spine
- pregnancy,
- aneurysms,
- osteitis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fascial Distortion ModelAlso: Manual treatment- Fascial Distortion ModelPatients 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 | Fascial Distortion Model group |
| Mulligan ConceptAlso: Manual treatment- Mulligan ConceptPatients 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 | Mulligan Concept group |
| Traditional physiotherapyPatients will receive traditional physiotherapy: Exercises, laser treatment, magnetic field therapy, ultrasound treatment, light treatment | Other | Traditional physiotherapy group |
Primary outcome
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.
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.
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).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 21839150Tesarz 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.
- Background: PubMed 24639633Liljencrantz 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.
- Background: PubMed 18952123Olausson 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.
- Background: PubMed 22852442Stecco C, Macchi V, Porzionato A, Duparc F, De Caro R. The fascia: the forgotten structure. Ital J Anat Embryol. 2011;116(3):127-38.
- Background: PubMed 23801005Stecco 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.
- Background: PubMed 21697306Jacobson JA. Shoulder US: anatomy, technique, and scanning pitfalls. Radiology. 2011 Jul;260(1):6-16. doi: 10.1148/radiol.11101082.
- Background: PubMed 28167173Adstrum 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.
- Background: PubMed 14435991RALSTON 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.
- Background: PubMed 19166469Benjamin 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.
- Background: PubMed 26311620Dawidowicz 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.
- Background: PubMed 21949456Gillies 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.
- Background: PubMed 24695087Ingber 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.
- Fascia: The Tensional Network of the Human BodyLink provided by the sponsor.
- Fascia, somatics, proprioception and improvement of motion precisionLink provided by the sponsor.
- Complexity of the Tensegrity Structure for Dynamic Energy and Force Distribution of Cytoskeleton during Cell SpreadingLink provided by the sponsor.
- Fascial plasticity - a new neurobiological explanationLink provided by the sponsor.
- Methodology for assessing the quality of lifeLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bartosz Molik, Professor study chair
Józef Piłsudski University of Physical Education
Questions about this trial
What is this clinical trial studying?
A study testing Fascial Distortion Model, Mulligan Concept and Traditional physiotherapy in people with Shoulder Pain, run by Józef Piłsudski University of Physical Education.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrian Rogala, MSc (537067960 ext. +48, adrian.kamil.rogala@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline DASH Outcome Measure at 3 months (time frame: 1'st day, 2 weeks after treatment, 3 months after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03521778, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.