Assessment of a Knee Brace in Patients With Osteoarthritis

Irmandade da Santa Casa de Misericordia de Sao Paulo

Status and phase: Unknown; Phase 4

Conditions: Osteoarthritis

Treatments: Device: Knee brace

Study type: Interventional

Funder types: Other

Identifiers

NCT02706106

SCMAA01

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups, including a placebo group

Knee brace with a hole

Experimental group

Description:

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.

Treatment:

Device: Knee brace

Knee brace without a hole

Placebo Comparator group

Description:

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.

Treatment:

Device: Knee brace