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

NCT02576028 | Completed

• 1 other identifier: U1111-1173-0402
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthritis

Keywords

Total Hip Replacement; Manipulation Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Range of motion (ROM)

  before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)

• Harris Hip Score

  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)

  before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)

Study Arms (2)

standard treathment

OTHER

two sessions of 45 minutes of active exercises for 10 days

Other: standard active exercises

FM associated to standard treathment

EXPERIMENTAL

the same intervention of CG except on days 2 and 7 where one session treatment was replaced with a FM treatment.

Other: Fascial Manipulation® (FM); Other: standard active exercises

Interventions

Fascial Manipulation® (FM) OTHER

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

FM associated to standard treathment

standard active exercises OTHER

two sessions of 45 minutes of active exercises

FM associated to standard treathment; standard treathment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• first THA surgery,
• posterior-lateral access,
• onset of pain of maximum 2 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Bolognini di Seriate Bergamo: lead

Related Publications (1)

• 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.

  PMID: 27210234 DERIVED

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 15, 2015
• Study Start: October 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 22, 2015

Record last verified: 2015-10