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Effectiveness of Fascial Manipulation in Rotator's Cuff Surgery Patients

NCT ID: NCT01888016

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-06-30

Brief Summary

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The purpose is to evaluate the effectiveness of fascial manipulation treatment in terms to reduce pain and improve physical functionality after rotator's cuff surgery. The technique involves deep friction manipulation of fascia's specific spots. Distant from surgical site.

Detailed Description

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To evaluate the effectiveness of fascial manipulation treatment associated with standard physiotherapies treatment in rotator's cuff surgery patients, we'll randomize about 60 patients for arm's of study. Both arm's will receive 10 standard physiotherapies treatments in 2 weeks while the experimental arm will receive 3 manual intervention on deep fascial tissues, according to fascial manipulation technique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.

To evaluate the effectiveness of fascial manipulation treatment we'll use 2 type of outcome measure and we will compare the result of both arms of study.

Conditions

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Cuff Rotator Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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fascial manipulation

Group Type EXPERIMENTAL

fascial manipulation

Intervention Type OTHER

• 3 manual intervention on deep fascial tissues, according to fascial manipulation technique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.

standard physiotherapies treatment

Intervention Type OTHER

10 standard treatments in 2 weeks

* Deltoid and infraspinatus muscles electrotherapy
* Chair for passive continue mobilization at allowed range of motion (ROM). ½ h per day
* Scar massage
* Upper limb, cervical spine and scapula massages
* Passive and assisted/active shoulder mobilization exercises
* Scapula micro-mobilizations
* Gleno-humeral decoaptation
* Elbow, wrist and hand active mobilization
* Proprioceptive exercise with and without the aid of the mirror

standard treatment

Group Type ACTIVE_COMPARATOR

standard physiotherapies treatment

Intervention Type OTHER

10 standard treatments in 2 weeks

* Deltoid and infraspinatus muscles electrotherapy
* Chair for passive continue mobilization at allowed range of motion (ROM). ½ h per day
* Scar massage
* Upper limb, cervical spine and scapula massages
* Passive and assisted/active shoulder mobilization exercises
* Scapula micro-mobilizations
* Gleno-humeral decoaptation
* Elbow, wrist and hand active mobilization
* Proprioceptive exercise with and without the aid of the mirror

Interventions

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fascial manipulation

• 3 manual intervention on deep fascial tissues, according to fascial manipulation technique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.

Intervention Type OTHER

standard physiotherapies treatment

10 standard treatments in 2 weeks

* Deltoid and infraspinatus muscles electrotherapy
* Chair for passive continue mobilization at allowed range of motion (ROM). ½ h per day
* Scar massage
* Upper limb, cervical spine and scapula massages
* Passive and assisted/active shoulder mobilization exercises
* Scapula micro-mobilizations
* Gleno-humeral decoaptation
* Elbow, wrist and hand active mobilization
* Proprioceptive exercise with and without the aid of the mirror

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Rotator's cuff surgery patients that have been operated within the past 4/5 weeks
* Age between 18 to 65 years old

Exclusion Criteria

* Patients with traumatic shoulder's injury that involved bone's fractures.
* Severe underlying pathologies like rheumatic, neurological and cardio pathologies that affect the correct shoulder treatment
* Patients on anticoagulant treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Grazia Benedetti, MD

Role: STUDY_CHAIR

Istituto Ortopedico Rizzoli

Locations

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Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Manifa

Identifier Type: -

Identifier Source: org_study_id