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

Not Applicable

Completed

• Conditions: Arthritis
• Interventions: Other: Fascial Manipulation® (FM); Other: standard active exercises

• Registration Number: NCT02576028
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-10
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2015-10
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-15
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FM associated to standard treathment	standard active exercises	the same intervention of CG except on days 2 and 7 where one session treatment was replaced with a FM treatment.
standard treathment	standard active exercises	two sessions of 45 minutes of active exercises for 10 days
FM associated to standard treathment	Fascial Manipulation® (FM)	the same intervention of CG except on days 2 and 7 where one session treatment was replaced with a FM treatment.

Primary Outcome Measures

Name	Time	Method
change of pain during movement	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

Name	Time	Method
Range of motion (ROM)	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
Harris Hip Score	before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)	Functional outcome
Timed up and Go test (TuG)	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