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

NCT03041727 | Completed

• 1 other identifier: AOBolognini 1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shoulder Pain; Manual Therapy

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain

  VNS scale in the Apley 'Scratch Test

  Before and after the first treatment. A week after the enrollment.

Secondary Outcomes (9)

• shoulder' function

  Before and after the first treatment. A week after the enrollment.

• shoulder' function

  Before and after the fifth treatment, after five weeks. This will be the last treatment

• shoulder' function

  A month later the last treatment, as follow up

• Range of Movement of the shoulder

  Before and after the first treatment. A week after the enrollment.

• Range of Movement of the shoulder

  Before and after the fifth treatment, after five weeks.This will be the last treatment

Study Arms (2)

Standard Group

ACTIVE COMPARATOR

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

Intervention group

EXPERIMENTAL

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

Interventions

Fascial Manipulation OTHER

Fascial Manipulation is a manual therapy that focused on deep muscular fascial.

Intervention group

Standard exercises protocol OTHER

Stretching and strengthening exercises

Standard Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Bolognini di Seriate Bergamo: lead

Study Sites (1)

AO Bolognini

Seriate, Bergamo, 24068, Italy

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Busato, first level

  Azienda Ospedaliera Bolognini di Seriate Bergamo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be a statistic techinician, with any knowledge about the group composition and the rehabilitative intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 3, 2017
• Study Start: February 1, 2017
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)