Clinical trial NCT02576028: 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
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Keywords: Total Hip Replacement
Manipulation Therapy
Lead sponsor: Azienda Ospedaliera Bolognini di Seriate Bergamo
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change of pain during movement
timeFrame: 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 outcomes:
measure: Range of motion (ROM)
timeFrame: before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)
measure: Harris Hip Score
timeFrame: before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)
measure: Timed up and Go test (TuG)
timeFrame: before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)
Other outcomes:
Locations:
Study officials:
References:
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.