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Effectiveness of Fascial Manipulation in Rotator's Cuff Surgery Patients

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ClinicalTrials.gov Identifier: NCT01888016
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

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.

Condition or disease Intervention/treatment Phase
Cuff Rotator Syndrome Other: fascial manipulation Other: standard physiotherapies treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Fascial Manipulation in Early Rehabilitation Treatment of Rotator's Cuff Surgery Patients. A Randomized Trial.
Study Start Date : June 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. visual analogue scale (VAS)mean [ Time Frame: Change from baseline in pain at the end of the rehabilitation cycle (two weeks) ]
    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)


Secondary Outcome Measures :
  1. Constant Murley score [ Time Frame: Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks) ]
    Constant Murley score for range of motion and shoulder function assessment.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888016


Locations
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Italy
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Study Chair: Maria Grazia Benedetti, MD Istituto Ortopedico Rizzoli
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Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT01888016    
Other Study ID Numbers: Manifa
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: August 2015