Effectiveness of Fascial Manipulation in Rotator's Cuff Surgery Patients

NCT01888016 | Completed

• 1 other identifier: Manifa
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cuff Rotator Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Constant Murley score

  Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks)

Study Arms (2)

fascial manipulation

EXPERIMENTAL

Other: fascial manipulation; Other: standard physiotherapies treatment

standard treatment

ACTIVE COMPARATOR

Other: standard physiotherapies treatment

Interventions

fascial manipulation 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.

fascial manipulation

standard physiotherapies treatment 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

fascial manipulation; standard treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Study Officials

• Maria Grazia Benedetti, MD

  Istituto Ortopedico Rizzoli

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 27, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 20, 2015

Record last verified: 2015-08

Locations

IT (1)