Assessment of a Knee Brace in Patients With Osteoarthritis

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Knee brace

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Irmandade Da Santa Casa de Misericordia de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Knee brace with a hole; Patients will be prepared to receive the device of knee brace with a hole in the sit position. This intervention will be blinded. Patients will receive a mask covering their eyes and the knee brace will be placed by the researchers, then the knee area will be covered with a dark clothing bag, so the patient will not be able to guess which type of brace is wearing (with or without a hole). Patient will perform the tests without the mask covering their eyes and only the dark clot bag on their knee.	Device: Knee brace; Patients will be prepared to receive the device of knee brace with or without a hole in the sit position. This intervention will be blinded. Patients will receive a mask covering their eyes and the knee brace will be placed by the researchers, then the knee area will be covered with a dark clothing bag, so the patient will not be able to guess which type of brace is wearing (with or without a hole). Patient will perform the tests without the mask covering their eyes and only the dark clot bag on their knee.
Placebo Comparator: Knee brace without a hole; Patients will be prepared to receive the device of knee brace without a hole in the sit position. This intervention will be blinded. Patients will receive a mask covering their eyes and the knee brace will be placed by the researchers, then the knee area will be covered with a dark clothing bag, so the patient will not be able to guess which type of brace is wearing (with or without a hole). Patient will perform the tests without the mask covering their eyes and only the dark clot bag on their knee.	Device: Knee brace; Patients will be prepared to receive the device of knee brace with or without a hole in the sit position. This intervention will be blinded. Patients will receive a mask covering their eyes and the knee brace will be placed by the researchers, then the knee area will be covered with a dark clothing bag, so the patient will not be able to guess which type of brace is wearing (with or without a hole). Patient will perform the tests without the mask covering their eyes and only the dark clot bag on their knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on pain sensation	Change on pain sensation will be compared from the baseline (before wearing the brace knee) with the pain sensation right after or maximum five minutes after wearing the brace knee. This evaluation will be performed asking the patient to identify their pain sensation by the visual analogue scale (VAS).	Pain will be measured before and right after or maximum five minutes after wearing the brace knee

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on leg function	Change on leg function will be measured before wearing the knee brace (baseline) and compared with right after or maximum five minutes after wearing the knee brace evaluation. Leg function will be assessed by Time Up and Go (TUG) test.	Leg function will be measured before and right after or maximum five minutes after wearing the brace knee
Change on agility	Change on agility will be measured before wearing the knee brace (baseline) and compared to right after or maximum five minutes after wearing the brace knee evaluation. Agility will be assessed by 8 Meter Walk test. The time to complete this test will be recorded by the researchers and this time will be the result considered for comparison from baseline and after wearing the knee brace.	Agility will be measured before and right after or maximum five minutes after wearing the brace knee

Collaborators and Investigators

• Sponsor: Irmandade da Santa Casa de Misericordia de Sao Paulo
• Investigators: Principal Investigator: Marco N Added, MSc, Irmandade Da Santa Casa de Misericordia de Sao Paulo

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: November 28, 2015
• First Submitted That Met QC Criteria: March 7, 2016
• First Posted (Estimate): March 11, 2016

Study Record Updates

• Last Update Posted (Estimate): March 11, 2016
• Last Update Submitted That Met QC Criteria: March 7, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: SCMAA01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes