Effectiveness of Fascial Manipulation in Rotator's Cuff Surgery Patients

Cuff Rotator Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888016
• Other study ID #: Manifa
• Status: Completed
• Phase: N/A
• First received: June 25, 2013
• Last updated: November 18, 2015
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cuff Rotator Syndrome

Intervention

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.
• 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

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No