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

Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576028
• Other study ID #: U1111-1173-0402
• Status: Completed
• Phase: N/A
• First received: October 8, 2015
• Last updated: October 20, 2015
• Start date: October 2011
• Est. completion date: July 2013

Study information

• Verified date: October 2015
• Source: Azienda Ospedaliera Bolognini di Seriate Bergamo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis

Intervention

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
• standard active exercises
two sessions of 45 minutes of active exercises

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Bolognini di Seriate Bergamo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	Harris Hip Score	Functional outcome	before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)	No
Secondary	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)	No