Clinical trial NCT02706106: Assessment of a Knee Brace in Patients With Osteoarthritis
Official title: Assessment of a Knee Brace in Patients With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis
Lead sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a controlled clinical trial randomized, double-blind evaluator. Will be considered eligible patients, individuals of both sexes, aged 40 -60, to submit at least four items of knee osteoarthrosis classification criteria, according to the American College of Rheumatology, pain above four points in the visual analogue scale (VAS), diagnosed with knee osteoarthritis and who sought physical therapy treatment.

Patients will be randomized by a number sequence generated by a computer using Microsoft Excel (Microsoft Corporation, Redmond, Washington), in opaque envelopes by researcher who will not attend the study.Patients will be divided into two groups: group with knee patellar hole or group without knee patellar hole. Shortly after the selection of the knee, the patient will have his eyes blind or cover in order to keep it '' blind '' regarding the type of knee brace that it would use.

Finally evaluator 1 will cover the knee with a black cloak, making the second evaluator ''blind '' regarding the type of knee brace that will be used.

Two investigators will carry out the data collection. The first evaluator will collect information on the clinical characteristics of patients, including evaluation form, numerical pain scale, which measures the intensity of pain, test Time Up and Go (TUG) test that measures the basic mobility of movement and test walking eight meters, whose purpose is to measure the time that the individual takes to walk a distance of eight meters.


Eligibility criteria: Inclusion Criteria:

* individuals of both sexes
* aged 40 -60
* at least four items of knee osteoarthrosis classification criteria, according to the American College of Rheumatology,
* pain above four points in the visual analogue scale (VAS)
* diagnosed with knee osteoarthritis
* no physical therapy treatment prior

Exclusion Criteria:

* neurological impairment
* partial or total knee prosthesis
* cardio-respiratory diseases
* pregnant women
* individuals who failed to perform the tests proposed

Primary outcomes:
measure: Change on pain sensation
timeFrame: Pain will be measured before and right after or maximum five minutes after wearing the brace knee
Secondary outcomes:
measure: Change on leg function
timeFrame: Leg function will be measured before and right after or maximum five minutes after wearing the brace knee
measure: Change on agility
timeFrame: Agility will be measured before and right after or maximum five minutes after wearing the brace knee
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de São Paulo
Study officials:
affiliation: Irmandade da Santa Casa de Misericórdia de São Paulo
name: Marco N Added, MSc
role: PRINCIPAL_INVESTIGATOR
References: