NCT02305108

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

September 30, 2014

Last Update Submit

November 18, 2015

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • pain is measured by numeric rating scale

    3 weeks before surgery

Secondary Outcomes (1)

  • performance measurement assessed with Oxford Hip Scale, 30 second chair stand test, 10 meters walking test, Iova level of assistance.

    a month after surgery

Study Arms (2)

fascial manipolation and standard

EXPERIMENTAL
Other: fascial manipulationOther: standard treatment

standard treatment

ACTIVE COMPARATOR
Other: standard treatment

Interventions

fascial manipulationOTHER

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).

fascial manipolation and standard
standard treatmentOTHER

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.

fascial manipolation and standardstandard treatment

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Bo, 40136, Italy

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Andrea Cotti, PT

    Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 30, 2014

First Posted

December 2, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-08

Locations

IT(1)