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Assessment of a Knee Brace in Patients With Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02706106
Recruitment Status : Unknown
Verified March 2016 by Marco Aurélio Nemitalla Added, Irmandade da Santa Casa de Misericordia de Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : March 11, 2016
Last Update Posted : March 11, 2016
Sponsor:
Information provided by (Responsible Party):
Marco Aurélio Nemitalla Added, Irmandade da Santa Casa de Misericordia de Sao Paulo

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Knee brace Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of a Knee Brace in Patients With Osteoarthritis
Study Start Date : November 2015
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.




Primary Outcome Measures :
  1. Change on pain sensation [ Time Frame: Pain will be measured before and right after or maximum five minutes after wearing the brace knee ]
    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).


Secondary Outcome Measures :
  1. 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 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.

  2. Change on agility [ Time Frame: Agility will be measured before and right after or maximum five minutes after wearing the brace knee ]
    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.



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706106


Locations
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Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Irmandade da Santa Casa de Misericordia de Sao Paulo
Investigators
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Principal Investigator: Marco N Added, MSc Irmandade da Santa Casa de Misericórdia de São Paulo

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Responsible Party: Marco Aurélio Nemitalla Added, Master in Science, Irmandade da Santa Casa de Misericordia de Sao Paulo
ClinicalTrials.gov Identifier: NCT02706106     History of Changes
Other Study ID Numbers: SCMAA01
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases