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Bracing for Patellofemoral Osteoarthritis

Primary Purpose

Knee Osteoarthritis, Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Womac
Lequesne
Timed-up-and-go (TUG)
five-times-sit-to-stand-test (FTSST)
Six-minute walk test.
functional patellofemoral neoprene brace
neoprene sleeve brace.
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee, knee osteoarthritis, Bracing, patellofemoral osteoarthritis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with symptomatic knee OA (patellofemoral)
  • Exclusion Criteria:
  • Not using the brace as requested;
  • Study abandonment;
  • No adaptation to brace;
  • Skin and vascular complications by use of the brace;
  • Failure to complete the consumption of drugs between inclusion and bracing;
  • Obesity class II, III or morbid;
  • Patients who cannot read or understand the informed consent or the WOMAC questionnaire;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    functional patellofemoral neoprene brace

    neoprene sleeve brace.

    Arm Description

    26 Patients will use a a functional patellofemoral neoprene brace and answer WOMAC, Lequesne questionnaires, perform Timed-up-and-go (TUG), five-times-sit-to-stand-test (FTSST) and the six-minute walk test.

    26 Patients will use a neoprene sleeve brace and answer WOMAC, Lequesne questionnaires, perform Timed-up-and-go (TUG), five-times-sit-to-stand-test (FTSST) and the six-minute walk test.

    Outcomes

    Primary Outcome Measures

    Evaluate improvement in function
    Apply the Lequesne questionnaire

    Secondary Outcome Measures

    Improvement in pain
    Apply the WOMAC questionnaire
    Improvement in stiffness
    Apply the WOMAC questionnaire
    Improvement in function with the TUG (Timed-Up-and-Go)
    Apply TUG (Time-up-Go test)
    Improvement in function with Five-Times-Sit-To-Stand-Test (FTSST)
    Apply Five-Times-Sit-To-Stand-Test (FTSST)
    Improvement in function with six minute walk test
    Apply six minute walk test

    Full Information

    First Posted
    October 31, 2016
    Last Updated
    January 23, 2019
    Sponsor
    University of Sao Paulo General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02984254
    Brief Title
    Bracing for Patellofemoral Osteoarthritis
    Official Title
    Bracing for Patellofemoral Osteoarthritis. A Prospective Randomized Study of the Treatment of Patellofemoral Arthritis by an Orthosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 20, 2016 (Actual)
    Primary Completion Date
    October 30, 2018 (Actual)
    Study Completion Date
    December 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    BACKGROUND: Despite the prevalence of patellofemoral ostearthritis (OA), this joint has received relatively little attention in the OA literature and there are few treatment options for individuals with patellofemoral OA. Patellar misalignment is associated with radiographic progression patellofemoral OA and symptoms and in magnetic resonance imaging (MRI), to cartilage loss measurements and bone marrow lesions. The hypothesis is that the correction of the patella disorder using strategies such as bracing or adhesive bandages can handle the symptoms and progression of OA. OBJECTIVE: To compare the effect of a brace designed to stabilize the patellofemoral joint compared with a neoprene sleeve with kneecap opening in patients with patellofemoral OA. METHODS: Fifty-two patients with patellofemoral OA and co-morbidities (Two or more of: overweight or obesity, hyperglycemia, dyslipidemia, hyperuricemia, high blood pressure) will be divided into two groups according to the knee brace that will receive: Functional Bracing patellofemoral (group 1) and neoprene knee sleeve with patella opening (group 2). Both groups will be oriented on the clinical treatment of osteoarthritis and metabolic syndrome and asked to do daily exercises in addition to reporting the daily consumption of drugs a month before placing the orthotics up to three months after placing it. They will be evaluated with the questionnaires WOMAC and Lequesne, and asked to perform the five-times-sit-to-stand-test, Timed-up-and-go (TUG) and the six-minute walk test in the moments immediately prior to placement of the brace, with one, three and after 12 months bracing.
    Detailed Description
    All patients that sign the informed consent will be randomized and asked to participate in a 4-hour course about knee osteoarthritis. They will be sent home with a form to fill in all medications consumed daily for a month. They will return to the hospital where according to data given by www.randomization.com, they will receive one of two braces in one or both knees depending on their symptoms. The functional brace has medial, lateral, superior and inferior "ruber bands" that should center patella in the patella groove. The other traditional neoprene sleeve brace with a patellar opening also tries to do the same with no other reinforcement other than the neoprene sleeve. Prior to bracing, patients will deliver the prior month medication form, answer WOMAC and Lequesne questionnaires, and perform TUG, FTSST and the six-minute walk test. They will be instructed to use the brace for 2 hours in the first day increasing half an hour per day up to a maximum of 12 hours/day. In case of difficulties with the brace for 12 continuous hours, they will be allowed to use it for at least 4 hours with a 2 hours interval and then again returning to bracing. Patients should sleep/rest without the brace(s). They should use their braces during physical activities unless if under water. The primary objective is to evaluate and compare the short-term benefits of knee stabilization and compression. Therefore, the follow-up assessments, will be made prior to bracing and after one and three months. The evaluation will include the delivery of the registration of medications consumed daily (along with the hours of use of the orthosis), the WOMAC and Lequesne questionnaires and functional evaluations. X-rays without the braces (Front Schuss, profile and Axial) for measurement of affected joint spaces will be made before inclusion and after one year. Panoramic X-rays of the lower limbs will be performed before inclusion to measure the internal and external femoral-tibial angle. Complaints (pain, slip, swelling, skin lesions) and satisfaction (decrease pain, mobility improvement) with the use of the brace will be sought at each encounter. Patients will be asked about their weekly physical activity (intensity, type and hours of physical activity) on any adverse effects when using orthotics. Weight and height will be measured and each assessment to calculate BMI. The secondary objective is the improvement in pain, stiffness and long-term function (1 year). Therefore, after a brief analysis of the results of three months, if there is a clinically significant difference between the groups, all patients will use the brace with best results. Therefore the study will be a case series. If both groups show clinically relevant improvements with no significant differences between the orthotics, the study will remain with two arms and the same clinical assessments, questionnaires, functional and radiographic one year. If none of the groups show a clinically relevant improvement in three months, the study will be terminated. Adverse effects of the use of orthotics will also be recorded in the one-year visit. All patients will be advised to discontinue use of the braces and telephone to our secretary in case of any adverse effects in the period between the official evaluations for proper conduct.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis, Metabolic Disease
    Keywords
    knee, knee osteoarthritis, Bracing, patellofemoral osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    functional patellofemoral neoprene brace
    Arm Type
    Experimental
    Arm Description
    26 Patients will use a a functional patellofemoral neoprene brace and answer WOMAC, Lequesne questionnaires, perform Timed-up-and-go (TUG), five-times-sit-to-stand-test (FTSST) and the six-minute walk test.
    Arm Title
    neoprene sleeve brace.
    Arm Type
    Experimental
    Arm Description
    26 Patients will use a neoprene sleeve brace and answer WOMAC, Lequesne questionnaires, perform Timed-up-and-go (TUG), five-times-sit-to-stand-test (FTSST) and the six-minute walk test.
    Intervention Type
    Device
    Intervention Name(s)
    Womac
    Intervention Description
    Answer Womac questionnaires at baseline, 1 month, 3 months and 1 year
    Intervention Type
    Device
    Intervention Name(s)
    Lequesne
    Intervention Description
    Answer Lequesne questionnaires at baseline, 1 month, 3 months and 1 year
    Intervention Type
    Device
    Intervention Name(s)
    Timed-up-and-go (TUG)
    Intervention Description
    Perform Timed-up-and-go (TUG) at baseline, 1 month, 3 months and 1 year
    Intervention Type
    Device
    Intervention Name(s)
    five-times-sit-to-stand-test (FTSST)
    Intervention Description
    Perform the five-times-sit-to-stand-test (FTSST) at baseline, 1 month, 3 months and 1 year
    Intervention Type
    Device
    Intervention Name(s)
    Six-minute walk test.
    Intervention Description
    Perform six-minute walk test at baseline, 3 months and 1 year
    Intervention Type
    Device
    Intervention Name(s)
    functional patellofemoral neoprene brace
    Intervention Description
    Use the functional patellofemoral neoprene brace for 2 hours/day minimum - 12 hours/day maximum
    Intervention Type
    Device
    Intervention Name(s)
    neoprene sleeve brace.
    Intervention Description
    Use the neoprene sleeve brace for 2 hours/day minimum - 12 hours/day maximum
    Primary Outcome Measure Information:
    Title
    Evaluate improvement in function
    Description
    Apply the Lequesne questionnaire
    Time Frame
    baseline and 3 months
    Secondary Outcome Measure Information:
    Title
    Improvement in pain
    Description
    Apply the WOMAC questionnaire
    Time Frame
    baseline, 1 month, 3 months and 1 year
    Title
    Improvement in stiffness
    Description
    Apply the WOMAC questionnaire
    Time Frame
    baseline, 1 month, 3 months and 1 year
    Title
    Improvement in function with the TUG (Timed-Up-and-Go)
    Description
    Apply TUG (Time-up-Go test)
    Time Frame
    baseline, 1 month, 3 months and 1 year
    Title
    Improvement in function with Five-Times-Sit-To-Stand-Test (FTSST)
    Description
    Apply Five-Times-Sit-To-Stand-Test (FTSST)
    Time Frame
    baseline, 1 month, 3 months and 1 year
    Title
    Improvement in function with six minute walk test
    Description
    Apply six minute walk test
    Time Frame
    baseline, 1 month, 3 months and 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with symptomatic knee OA (patellofemoral) Exclusion Criteria: Not using the brace as requested; Study abandonment; No adaptation to brace; Skin and vascular complications by use of the brace; Failure to complete the consumption of drugs between inclusion and bracing; Obesity class II, III or morbid; Patients who cannot read or understand the informed consent or the WOMAC questionnaire;
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marcia U Rezende, MD; PhD
    Organizational Affiliation
    Department of Orthopedics and Traumatology - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
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    17013996
    Citation
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    Links:
    URL
    https://www.omicsonline.org/peer-reviewed/parqveproject-arthritis-recovering-quality-of-life-by-means-of-education-shortterm-outcome-in-a-randomized-clinical-trial-20432.html
    Description
    PARQVE - Project Arthritis Recovering Quality of Life by means of Education. Short-term outcome in a randomized clinical trial
    URL
    http://file.scirp.org/pdf/OJO_2016022614241788.pdf
    Description
    . Analysis of anthropometric measures and dietary intake in patients undergoing a multi-professional osteoarthritis education program (PARQVE - Project Arthritis Recovering Quality of Life by means of Education
    URL
    http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0482-50042006000400004
    Description
    Translation and cultural validation of the Lequesne's algofunctional questionnaire for osteoarthritis of knee and hip for portuguese language

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