Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatment knee brace
Phase phase 4
Sponsor Irmandade da Santa Casa de Misericordia de Sao Paulo
Start date November 2015
End date March 2016
Trial size 108 participants
Trial identifier NCT02706106, SCMAA01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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.
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)
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.
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.

Primary Outcomes

Measure
Change on pain sensation
time frame: Pain will be measured before and right after or maximum five minutes after wearing the brace knee

Secondary Outcomes

Measure
Change on leg function
time frame: Leg function will be measured before and right after or maximum five minutes after wearing the brace knee
Change on agility
time frame: Agility will be measured before and right after or maximum five minutes after wearing the brace knee

Eligibility Criteria

Male or female participants from 40 years up to 60 years old.

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

Additional Information

Official title Assessment of a Knee Brace in Patients With Osteoarthritis
Principal investigator Marco N Added, MSc
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Irmandade da Santa Casa de Misericordia de Sao Paulo.