Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 27, 2017
First Posted Date  ICMJE February 3, 2017
Last Update Posted Date June 26, 2018
Actual Study Start Date  ICMJE January 1, 2017
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
Shoulder Pain [ Time Frame: Before and after the first treatment. A week after the enrollment. ]
VNS scale in the Apley 'Scratch Test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
  • shoulder' function [ Time Frame: Before and after the first treatment. A week after the enrollment. ]
    Constant Morley Scale
  • shoulder' function [ Time Frame: Before and after the fifth treatment, after five weeks. This will be the last treatment ]
    Constant Morley Scale
  • shoulder' function [ Time Frame: A month later the last treatment, as follow up ]
    Constant Morley Scale
  • 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
  • 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
  • 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
  • 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
  • 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
  • The shoulder's muscular strength [ Time Frame: A month later the last treatment, as follow up ]
    dynamometer survey in flexion and abduction movement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiotherapist Approach to Shoulder's Diseases, Differences Between Fascial Manipulation and Standard Exercises
Official Title  ICMJE Physiotherapist Approach to Shoulder's Diseases, Differences Between Fascial Manipulation and Standard Exercise
Brief Summary The study purpose is to compare the effects of Fascial Manipulation added to standard exercises protocol versus the simple exercises protocol.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Shoulder Pain
  • Manual Therapy
Intervention  ICMJE
  • Other: Fascial Manipulation
    Fascial Manipulation is a manual therapy that focused on deep muscular fascial.
  • Other: Standard exercises protocol
    Stretching and strengthening exercises
Study Arms  ICMJE
  • 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.

    Intervention: Other: Standard exercises protocol
  • 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.
    Intervention: Other: Fascial Manipulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 2, 2017)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03041727
Other Study ID Numbers  ICMJE AOBolognini 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party silvia Bellotti, Azienda Ospedaliera Bolognini di Seriate Bergamo
Study Sponsor  ICMJE Azienda Ospedaliera Bolognini di Seriate Bergamo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Massimo Busato, first level Azienda Ospedaliera Bolognini di Seriate Bergamo
PRS Account Azienda Ospedaliera Bolognini di Seriate Bergamo
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP