Clinical trial NCT03521778: Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome
Official title: Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline DASH Outcome Measure at 3 months
timeFrame: 1'st day, 2 weeks after treatment, 3 months after treatment
measure: Change from baseline Constant-Murley Shoulder Outcome Score at 3 months
timeFrame: 1'st day, 3 months after treatment
measure: Change from baseline Quality Of Life Questionnaire SF- 36v2 at 3 months
timeFrame: 1'st day, 3 months after treatment
measure: Change from baseline Visual Analogue Scale at 3 months
timeFrame: 1'st day, 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Józef Piłsudski University of Physical Education
name: Bartosz Molik, Professor
role: STUDY_CHAIR
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