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

April 28, 2018 updated by: Adrian Rogala, Józef Piłsudski University of Physical Education

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fascial Distortion Model group
Patients will receive manual treatment complies with Fascial Distortion Model method.
Other: Fascial Distortion Model

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.
Other Names:
  • Manual treatment- Fascial Distortion Model
Experimental: Mulligan Concept group
Patients will receive manual treatment complies with Mulligan Concept method.
Other: 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.

Other Names:
  • Manual treatment- Mulligan Concept
Experimental: Traditional physiotherapy group
Patients will receive traditional physiotherapy.
Other: Traditional physiotherapy

Patients will receive traditional physiotherapy:

Exercises, laser treatment, magnetic field therapy, ultrasound treatment, light treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1'st day, 2 weeks after treatment, 3 months after treatment
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.
1'st day, 3 months after treatment
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).
1'st day, 3 months after treatment
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.
1'st day, 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Józef Piłsudski University of Physical Education

Investigators

  • Study Chair: Bartosz Molik, Professor, Józef Piłsudski University of Physical Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 25, 2018

Primary Completion (Anticipated)

August 30, 2019

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

April 15, 2018

First Submitted That Met QC Criteria

April 28, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

April 28, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JozefPilsudskiU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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