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

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

The study purpose is to compare the effects of Fascial Manipulation added to standard exercises protocol versus the simple exercises protocol.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain; Manual Therapy
• Intervention / Treatment: Other: Standard exercises protocol; Other: Fascial Manipulation

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: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bergamo
    • Seriate, Bergamo, Italy, 24068
      • AO Bolognini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain	VNS scale in the Apley 'Scratch Test	Before and after the first treatment. A week after the enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
shoulder' function	Constant Morley Scale	Before and after the first treatment. A week after the enrollment.
shoulder' function	Constant Morley Scale	Before and after the fifth treatment, after five weeks. This will be the last treatment
shoulder' function	Constant Morley Scale	A month later the last treatment, as follow up
Range of Movement of the shoulder	Bubble Inclinometer used in the flexion, abduction and external rotation movement	Before and after the first treatment. A week after the enrollment.
Range of Movement of the shoulder	Bubble Inclinometer used in the flexion, abduction and external rotation movement	Before and after the fifth treatment, after five weeks.This will be the last treatment
Range of Movement of the shoulder	Bubble Inclinometer used in the flexion, abduction and external rotation movement	A month later the last treatment, as follow up
The shoulder's muscular strength	dynamometer survey in flexion and abduction movement	Before and after the first treatment. A week after the enrollment.
The shoulder's muscular strength	dynamometer survey in flexion and abduction movement	Before and after the fifth treatment, after five weeks. This will be the last treatment
The shoulder's muscular strength	dynamometer survey in flexion and abduction movement	A month later the last treatment, as follow up

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Bolognini di Seriate Bergamo
• Investigators: Study Director: Massimo Busato, first level, Azienda Ospedaliera Bolognini di Seriate Bergamo

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: AOBolognini 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No