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

• Sponsor: Azienda Ospedaliera Bolognini di Seriate Bergamo (Other)
• Overall Status: Completed
• CT.gov ID: NCT03041727
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 53.9
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain; Manual Therapy	Other: Fascial Manipulation; Other: Standard exercises protocol	N/A

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

• Study Type: Interventional
• Actual 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.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: Feb 1, 2017
• Actual Primary Completion Date: Aug 1, 2021
• Actual Study Completion Date: Aug 1, 2021

Arms and Interventions

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

Primary Outcome Measures

1. Shoulder Pain [Before and after the first treatment. A week after the enrollment.]

   VNS scale in the Apley 'Scratch Test

Secondary Outcome Measures

1. shoulder' function [Before and after the first treatment. A week after the enrollment.]

   Constant Morley Scale

2. shoulder' function [Before and after the fifth treatment, after five weeks. This will be the last treatment]

   Constant Morley Scale

3. shoulder' function [A month later the last treatment, as follow up]

   Constant Morley Scale

4. Range of Movement of the shoulder [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 [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 [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 [Before and after the first treatment. A week after the enrollment.]

   dynamometer survey in flexion and abduction movement

8. The shoulder's muscular strength [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 [A month later the last treatment, as follow up]

   dynamometer survey in flexion and abduction movement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	AO Bolognini	Seriate	Bergamo	Italy	24068

Sponsors and Collaborators

• Azienda Ospedaliera Bolognini di Seriate Bergamo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: silvia Bellotti, Physiotherapist, Azienda Ospedaliera Bolognini di Seriate Bergamo
• ClinicalTrials.gov Identifier: NCT03041727
• Other Study ID Numbers: AOBolognini 1
• First Posted: Feb 3, 2017
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Shoulder Pain

Study Results

No Results Posted as of Feb 15, 2022