Effectiveness of Fascial Manipulation in Rotator's Cuff Surgery Patients

Effectiveness of Fascial Manipulation in Early Rehabilitation Treatment of Rotator's Cuff Surgery Patients. A Randomized Trial.

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.

Study Overview

• Status: Completed
• Conditions: Cuff Rotator Syndrome
• Intervention / Treatment: Other: fascial manipulation; Other: standard physiotherapies treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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 treatment	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
Experimental: fascial manipulation	Other: 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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale (VAS)mean	we'll compare the baseline data (the first evaluation), with data at the end of the treatment, and with follow up (30 days from surgery)	Change from baseline in pain at the end of the rehabilitation cycle (two weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Murley score	Constant Murley score for range of motion and shoulder function assessment.	Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks)

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Study Chair: Maria Grazia Benedetti, MD, Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: June 25, 2013
• First Posted (Estimate): June 27, 2013

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 18, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: Manifa