Assessment of a Knee Brace in Patients With Osteoarthritis

NCT02706106 | Unknown Phase 4

• 1 other identifier: SCMAA01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change on leg function

  Leg function will be measured before and right after or maximum five minutes after wearing the brace knee

• Change on agility

  Agility will be measured before and right after or maximum five minutes after wearing the brace knee

Study Arms (2)

Knee brace with a hole

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.

Device: Knee brace

Knee brace without a hole

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.

Device: Knee brace

Interventions

Knee brace DEVICE

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.

Knee brace with a hole; Knee brace without a hole

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• neurological impairment
• partial or total knee prosthesis
• cardio-respiratory diseases
• pregnant women
• individuals who failed to perform the tests proposed

Sponsors & Collaborators

• Irmandade da Santa Casa de Misericordia de Sao Paulo: lead

Study Sites (1)

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Marco N Added, MSc

  Irmandade da Santa Casa de Misericórdia de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Science

Study Record Dates

• First Submitted: November 28, 2015
• First Posted: March 11, 2016
• Study Start: November 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 11, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)