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Completed

NCT Number: NCT01888016

Effectiveness of Fascial Manipulation in Rotator's Cuff Surgery Patients

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.

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Key information

Conditions

Cuff Rotator Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 27, 2013
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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