search
Back to results

Fascial Manipulation® Associated With Standard Care Versus Standard Post-surgical Care for Total Hip Arthroplasty

Primary Purpose

Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fascial Manipulation® (FM)
standard active exercises
Sponsored by
Azienda Ospedaliera Bolognini di Seriate Bergamo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis focused on measuring Total Hip Replacement, Manipulation Therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • first THA surgery,
  • posterior-lateral access,
  • onset of pain of maximum 2 years

Exclusion Criteria:

  • patients with previous hip or knee prosthesis,
  • congenital hip dysplasia,
  • revision THA,
  • elective THA secondary to trauma,
  • real leg-length discrepancy (≥1.5cm),
  • cognitive impairment,
  • concomitant rheumatic pathology in acute phase,
  • serious comorbidities including cardiac,
  • respiratory and/or neuromuscular pathologies.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    standard treathment

    FM associated to standard treathment

    Arm Description

    two sessions of 45 minutes of active exercises for 10 days

    the same intervention of CG except on days 2 and 7 where one session treatment was replaced with a FM treatment.

    Outcomes

    Primary Outcome Measures

    change of pain during movement
    value of pain during a specific movement , measured with Visual Numeric Scale (VNS) scale

    Secondary Outcome Measures

    Range of motion (ROM)
    hip ROM amplitude, measured with bobble inclinometer
    Harris Hip Score
    Functional outcome
    Timed up and Go test (TuG)
    functional test for stand up and walk speed

    Full Information

    First Posted
    October 8, 2015
    Last Updated
    October 20, 2015
    Sponsor
    Azienda Ospedaliera Bolognini di Seriate Bergamo
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02576028
    Brief Title
    Fascial Manipulation® Associated With Standard Care Versus Standard Post-surgical Care for Total Hip Arthroplasty
    Official Title
    Fascial Manipulation® Associated With Standard Care Versus Standard Post-surgical Care for Total Hip Arthroplasty: a Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2011 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Azienda Ospedaliera Bolognini di Seriate Bergamo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show important differences between types and numbers of treatment sessions. Objectives are to investigate effectiveness of Fascial Manipulation when associated to a standard protocol of care.
    Detailed Description
    Background. Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show important differences between types and numbers of treatment sessions. Objectives are to investigate effectiveness of Fascial Manipulation when associated to a standard protocol of care. Methods. Fifty-one subjects operated with THA were randomized into two groups, both followed a standard protocol of care where two sessions were replaced with Fascial Manipulation in the study group. Functional outcomes measures collected before and after treatment and at the end of the rehabilitation program included Harris Hip Score, Time Up and Go test, articular range of motion and verbal numerical scale.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthritis
    Keywords
    Total Hip Replacement, Manipulation Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    standard treathment
    Arm Type
    Other
    Arm Description
    two sessions of 45 minutes of active exercises for 10 days
    Arm Title
    FM associated to standard treathment
    Arm Type
    Experimental
    Arm Description
    the same intervention of CG except on days 2 and 7 where one session treatment was replaced with a FM treatment.
    Intervention Type
    Other
    Intervention Name(s)
    Fascial Manipulation® (FM)
    Intervention Description
    Fascial Manipulation® (FM) is a manual therapy that focus on the deep muscular fascia. This technique considers the fascia as a three-dimensional continuum. The mainstay of this manual technique lies in the identification of specific localised areas of the fascia, defined Center of Coordination (CC), where the gliding of the subcutis should be preserved to avoid biomechanical in-coordination of the surrounding muscles. The method is performed by applying a deep friction over the CCs that result more altered at the clinical palpation
    Intervention Type
    Other
    Intervention Name(s)
    standard active exercises
    Intervention Description
    two sessions of 45 minutes of active exercises
    Primary Outcome Measure Information:
    Title
    change of pain during movement
    Description
    value of pain during a specific movement , measured with Visual Numeric Scale (VNS) scale
    Time Frame
    change from before and after the 2nd day treatment, change from before and after the 7nd day treatment, change from 2nd and 10th day (end of study)
    Secondary Outcome Measure Information:
    Title
    Range of motion (ROM)
    Description
    hip ROM amplitude, measured with bobble inclinometer
    Time Frame
    before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)
    Title
    Harris Hip Score
    Description
    Functional outcome
    Time Frame
    before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)
    Title
    Timed up and Go test (TuG)
    Description
    functional test for stand up and walk speed
    Time Frame
    before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: first THA surgery, posterior-lateral access, onset of pain of maximum 2 years Exclusion Criteria: patients with previous hip or knee prosthesis, congenital hip dysplasia, revision THA, elective THA secondary to trauma, real leg-length discrepancy (≥1.5cm), cognitive impairment, concomitant rheumatic pathology in acute phase, serious comorbidities including cardiac, respiratory and/or neuromuscular pathologies.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27210234
    Citation
    Busato M, Quagliati C, Magri L, Filippi A, Sanna A, Branchini M, Marchand AM, Stecco A. Fascial Manipulation Associated With Standard Care Compared to Only Standard Postsurgical Care for Total Hip Arthroplasty: A Randomized Controlled Trial. PM R. 2016 Dec;8(12):1142-1150. doi: 10.1016/j.pmrj.2016.04.007. Epub 2016 May 19.
    Results Reference
    derived

    Learn more about this trial

    Fascial Manipulation® Associated With Standard Care Versus Standard Post-surgical Care for Total Hip Arthroplasty

    We'll reach out to this number within 24 hrs