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

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ClinicalTrials.gov Identifier: NCT02576028
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliera Bolognini di Seriate Bergamo

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.

Condition or disease Intervention/treatment Phase
Arthritis Other: Fascial Manipulation® (FM) Other: standard active exercises Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Fascial Manipulation® Associated With Standard Care Versus Standard Post-surgical Care for Total Hip Arthroplasty: a Randomized Controlled Trial.
Study Start Date : October 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
standard treathment
two sessions of 45 minutes of active exercises for 10 days
Other: standard active exercises
two sessions of 45 minutes of active exercises

Experimental: FM associated to standard treathment
the same intervention of CG except on days 2 and 7 where one session treatment was replaced with a FM treatment.
Other: Fascial Manipulation® (FM)
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

Other: standard active exercises
two sessions of 45 minutes of active exercises




Primary Outcome Measures :
  1. change of pain during movement [ 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) ]
    value of pain during a specific movement , measured with Visual Numeric Scale (VNS) scale


Secondary Outcome Measures :
  1. Range of motion (ROM) [ Time Frame: before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study) ]
    hip ROM amplitude, measured with bobble inclinometer

  2. Harris Hip Score [ Time Frame: before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study) ]
    Functional outcome

  3. Timed up and Go test (TuG) [ Time Frame: before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study) ]
    functional test for stand up and walk speed



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Azienda Ospedaliera Bolognini di Seriate Bergamo
ClinicalTrials.gov Identifier: NCT02576028     History of Changes
Other Study ID Numbers: U1111-1173-0402
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by Azienda Ospedaliera Bolognini di Seriate Bergamo:
Total Hip Replacement
Manipulation Therapy