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
About this trial
This is an interventional treatment trial for Arthritis focused on measuring Total Hip Replacement, Manipulation Therapy
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.
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
NCT ID
NCT02576028
First Posted
October 8, 2015
Last Updated
October 20, 2015
Sponsor
Azienda Ospedaliera Bolognini di Seriate Bergamo
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
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