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

Primary Purpose

Shoulder Pain, Manual Therapy

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Fascial Manipulation
Standard exercises protocol
Sponsored by
Azienda Ospedaliera Bolognini di Seriate Bergamo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • AO Bolognini

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Group

Intervention group

Arm Description

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.

The subjects will be treated with the same protocol of the Standard Group, but in two section, they will receive a Fascial Manipulation approach.

Outcomes

Primary Outcome Measures

Shoulder Pain
VNS scale in the Apley 'Scratch Test

Secondary Outcome Measures

shoulder' function
Constant Morley Scale
shoulder' function
Constant Morley Scale
shoulder' function
Constant Morley Scale
Range of Movement of the shoulder
Bubble Inclinometer used in the flexion, abduction and external rotation movement
Range of Movement of the shoulder
Bubble Inclinometer used in the flexion, abduction and external rotation movement
Range of Movement of the shoulder
Bubble Inclinometer used in the flexion, abduction and external rotation movement
The shoulder's muscular strength
dynamometer survey in flexion and abduction movement
The shoulder's muscular strength
dynamometer survey in flexion and abduction movement
The shoulder's muscular strength
dynamometer survey in flexion and abduction movement

Full Information

First Posted
January 27, 2017
Last Updated
February 14, 2022
Sponsor
Azienda Ospedaliera Bolognini di Seriate Bergamo
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1. Study Identification

Unique Protocol Identification Number
NCT03041727
Brief Title
Physiotherapist Approach to Shoulder's Diseases, Differences Between Fascial Manipulation and Standard Exercises
Official Title
Physiotherapist Approach to Shoulder's Diseases, Differences Between Fascial Manipulation and Standard Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Bolognini di Seriate Bergamo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Manual Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The outcome assessor will be a statistic techinician, with any knowledge about the group composition and the rehabilitative intervention.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Fascial Manipulation
Intervention Description
Fascial Manipulation is a manual therapy that focused on deep muscular fascial.
Intervention Type
Other
Intervention Name(s)
Standard exercises protocol
Intervention Description
Stretching and strengthening exercises
Primary Outcome Measure Information:
Title
Shoulder Pain
Description
VNS scale in the Apley 'Scratch Test
Time Frame
Before and after the first treatment. A week after the enrollment.
Secondary Outcome Measure Information:
Title
shoulder' function
Description
Constant Morley Scale
Time Frame
Before and after the first treatment. A week after the enrollment.
Title
shoulder' function
Description
Constant Morley Scale
Time Frame
Before and after the fifth treatment, after five weeks. This will be the last treatment
Title
shoulder' function
Description
Constant Morley Scale
Time Frame
A month later the last treatment, as follow up
Title
Range of Movement of the shoulder
Description
Bubble Inclinometer used in the flexion, abduction and external rotation movement
Time Frame
Before and after the first treatment. A week after the enrollment.
Title
Range of Movement of the shoulder
Description
Bubble Inclinometer used in the flexion, abduction and external rotation movement
Time Frame
Before and after the fifth treatment, after five weeks.This will be the last treatment
Title
Range of Movement of the shoulder
Description
Bubble Inclinometer used in the flexion, abduction and external rotation movement
Time Frame
A month later the last treatment, as follow up
Title
The shoulder's muscular strength
Description
dynamometer survey in flexion and abduction movement
Time Frame
Before and after the first treatment. A week after the enrollment.
Title
The shoulder's muscular strength
Description
dynamometer survey in flexion and abduction movement
Time Frame
Before and after the fifth treatment, after five weeks. This will be the last treatment
Title
The shoulder's muscular strength
Description
dynamometer survey in flexion and abduction movement
Time Frame
A month later the last treatment, as follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Busato, first level
Organizational Affiliation
Azienda Ospedaliera Bolognini di Seriate Bergamo
Official's Role
Study Director
Facility Information:
Facility Name
AO Bolognini
City
Seriate
State/Province
Bergamo
ZIP/Postal Code
24068
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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

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