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

Fascial Manipulation® Associated With Standard Care Versus Standard Post-surgical Care for Total Hip Arthroplasty: a Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Arthritis
• Intervention / Treatment: Other: standard active exercises; Other: Fascial Manipulation® (FM)

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
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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: standard active exercises; two sessions of 45 minutes of active exercises; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of pain during movement	value of pain during a specific movement , measured with Visual Numeric Scale (VNS) scale	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 Measures

Outcome Measure	Measure Description	Time Frame
Range of motion (ROM)	hip ROM amplitude, measured with bobble inclinometer	before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)
Harris Hip Score	Functional outcome	before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)
Timed up and Go test (TuG)	functional test for stand up and walk speed	before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Bolognini di Seriate Bergamo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: October 8, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (ESTIMATE): October 15, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): October 22, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Total Hip Replacement; Manipulation Therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: U1111-1173-0402