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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02305108
Other study ID # Prot. gen. 0018810
Secondary ID
Status Completed
Phase N/A
First received September 30, 2014
Last updated November 18, 2015
Start date June 2014
Est. completion date June 2015

Study information

Verified date August 2015
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

The study will test the efficacy of the treatment of soft tissues for osteoarthritis patients that are waiting for total hip arthroplasty. The fascial manipulation provides a deep pressure of specific points of the muscle fascia. The aims of this treatment are the improve of pain before the surgery and the improve of functional performance after the surgery.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- patients age 40-80, with primary coxarthrosis waiting for total hip arthroplasty that complain a pain measured by Numeric Rating Scale = 5 and that live in Bologna

Exclusion Criteria:

- arthroplasty revision or substitution. Patient with cognitive deficiency and severe comorbidity (rheumatic, neurological or cardiovascular pathology)

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
fascial manipulation
Recruited patients in study's group will be treated with the standard treatment and fascial manipulation. Specific points of fascial tissue will be treated with a deep friction to improve elasticity. The number of point treated will be refered to a specific evaluation for each patient. Fascial manipulation provide 3 session treatment (one treatment for week).
standard treatment
Before surgery, standard physiotherapy treatment provides an education session about the rehabilitation program tha is going to be execute after surgery. After surgery 2 daily physiotherapy treatment are implemented: bed exercise as active and passive flex-extension of lower limb, movements for postural change to reach sitting and standing position, walking training.

Locations

Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna Bo

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain is measured by numeric rating scale 3 weeks before surgery No
Secondary performance measurement assessed with Oxford Hip Scale, 30 second chair stand test, 10 meters walking test, Iova level of assistance. a month after surgery No
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