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Physiotherapist Approach to Shoulder's Diseases, Differences Between Fascial Manipulation and Standard Exercises

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ClinicalTrials.gov Identifier: NCT03041727
Recruitment Status : Unknown
Verified June 2018 by silvia Bellotti, Azienda Ospedaliera Bolognini di Seriate Bergamo.
Recruitment status was:  Recruiting
First Posted : February 3, 2017
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
silvia Bellotti, Azienda Ospedaliera Bolognini di Seriate Bergamo

Study Description
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Brief Summary:
The study purpose is to compare the effects of Fascial Manipulation added to standard exercises protocol versus the simple exercises protocol.

Condition or disease Intervention/treatment Phase
Shoulder Pain Manual Therapy Other: Fascial Manipulation Other: Standard exercises protocol Not Applicable

Detailed Description:

The shoulder degenerative diseases are recurring in hospital employees. The early approach, as we see in literature, has high probability to reduce the pain and the disfunction in the long term.

In particular stretching and strengthening exercises are the standard protocol applied.

The Fascial Manipulation is a manual therapy that works on the connective tissue, by increasing mobility and reducing pain.

We have added the Fascial Manipulation to prove if it make a faster recovery and a pain reduction in the short and the middle term.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of two or more groups in parallel for the duration of the study are evaluated in parallel against a control group.
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor will be a statistic techinician, with any knowledge about the group composition and the rehabilitative intervention.
Primary Purpose: Treatment
Official Title: Physiotherapist Approach to Shoulder's Diseases, Differences Between Fascial Manipulation and Standard Exercise
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Group

The subjects will be treated with a standard protocol of stretching and strengthening exercises , we require them to do the exercises by themselves during five weeks, one a day.

To make sure that they will do the protocol, we'll give them a diary to sign the daily section.

 Other: Standard exercises protocol
Stretching and strengthening exercises
Experimental: Intervention group
The subjects will be treated with the same protocol of the Standard Group, but in two section, they will receive a Fascial Manipulation approach.
 Other: Fascial Manipulation
Fascial Manipulation is a manual therapy that focused on deep muscular fascial.


Outcome Measures
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Primary Outcome Measures :
  1. Shoulder Pain [ Time Frame: Before and after the first treatment. A week after the enrollment. ]
    VNS scale in the Apley 'Scratch Test


Secondary Outcome Measures :
  1. shoulder' function [ Time Frame: Before and after the first treatment. A week after the enrollment. ]
    Constant Morley Scale

  2. shoulder' function [ Time Frame: Before and after the fifth treatment, after five weeks. This will be the last treatment ]
    Constant Morley Scale

  3. shoulder' function [ Time Frame: A month later the last treatment, as follow up ]
    Constant Morley Scale

  4. Range of Movement of the shoulder [ Time Frame: Before and after the first treatment. A week after the enrollment. ]
    Bubble Inclinometer used in the flexion, abduction and external rotation movement

  5. Range of Movement of the shoulder [ Time Frame: Before and after the fifth treatment, after five weeks.This will be the last treatment ]
    Bubble Inclinometer used in the flexion, abduction and external rotation movement

  6. Range of Movement of the shoulder [ Time Frame: A month later the last treatment, as follow up ]
    Bubble Inclinometer used in the flexion, abduction and external rotation movement

  7. The shoulder's muscular strength [ Time Frame: Before and after the first treatment. A week after the enrollment. ]
    dynamometer survey in flexion and abduction movement

  8. The shoulder's muscular strength [ Time Frame: Before and after the fifth treatment, after five weeks. This will be the last treatment ]
    dynamometer survey in flexion and abduction movement

  9. The shoulder's muscular strength [ Time Frame: A month later the last treatment, as follow up ]
    dynamometer survey in flexion and abduction movement


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • shoulder pain and acute and relapse in six months
  • positive results in two orthopedic testes

Exclusion Criteria:

  • Degenerative diseases and neurological diseases
  • Rheumatological Diseases and cancer
  • fracture of the humerus, scapula and collarbone
  • documented injury of rotator cuff.
  • cortisones therapy in action
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041727


Contacts
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Contact: Silvia Bellotti, first level 035730232 silviabellotti@icloud.com

Locations
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Italy
AO Bolognini Recruiting
Seriate, Bergamo, Italy, 24068
Contact: Silvia Bellotti, first level         
Sponsors and Collaborators
Azienda Ospedaliera Bolognini di Seriate Bergamo
Investigators
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Study Director: Massimo Busato, first level Azienda Ospedaliera Bolognini di Seriate Bergamo
More Information
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Responsible Party: silvia Bellotti, Physiotherapist, Azienda Ospedaliera Bolognini di Seriate Bergamo
ClinicalTrials.gov Identifier: NCT03041727    
Other Study ID Numbers: AOBolognini 1
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
 Musculoskeletal Diseases
Pain
Neurologic Manifestations