Assessment of a Knee Brace in Patients With Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Assessment of a Knee Brace in Patients With Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02706106
• Other study ID #: SCMAA01
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 28, 2015
• Last updated: March 7, 2016
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Irmandade da Santa Casa de Misericordia de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
Brazil	Irmandade da Santa Casa de Misericórdia de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Irmandade da Santa Casa de Misericordia de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No