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Completed

NCT Number: NCT02576028

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

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.

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

standard active exercises

Other

two sessions of 45 minutes of active exercises

Primary outcomes

  1. change of pain during movement

    Time frame: 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 outcomes

  1. Range of motion (ROM)

    Time frame: 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

  2. Harris Hip Score

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

    Functional outcome

  3. Timed up and Go test (TuG)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Bolognini di Seriate Bergamo

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 15, 2015
Registry last updated
Oct 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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