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Educational Program for Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational Program
Transcutaneous Nerve Electro-Stimulation
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Education, Pain, Function, Quality of life

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of knee Osteoarthritis by American College of Rheumatology criteria;
  • Age between 40 and 80 years;
  • Both genders;
  • Numerical Pain Scale in the knee between 3 and 8 centimeters on a scale of 0 to 10 centimeters.

Exclusion Criteria:

  • Systemic inflammatory diseases or any condition that prevents the practice of physical activity;
  • Regular physical activity started or changed in the last twelve weeks;
  • No ambulation;
  • Joint injection in the knee in the previous twelve weeks;
  • Previous knee surgery or surgery planned for the next twenty-four weeks;
  • Physiotherapy in the last twelve weeks;
  • Other disease that affects the lower limbs;
  • Open wounds at the electrode application site;
  • Planned trip in the next twelve weeks.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Education Group

    Control Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Pain
    Evaluated using a numeric pain scale

    Secondary Outcome Measures

    Change in function
    Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index
    Change in Anxiety
    Evaluated using the Inventory Anxiety Trait Inventory - State
    Change in Generic Quality of life
    Evaluated using the SF-36 questionnaire
    Change in Functional capacity
    Evaluated with the six minute walk test

    Full Information

    First Posted
    July 4, 2018
    Last Updated
    July 24, 2018
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03588195
    Brief Title
    Educational Program for Knee Osteoarthritis
    Official Title
    Evaluation of the Effectiveness of an Educational Program in Patients With Osteoarthritis of the Knee: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    October 24, 2017 (Actual)
    Study Completion Date
    June 17, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Sixty patients with a diagnosis of knee osteoarthritis, aged between 40 and 80 years, of both genders were included. The patients were divided into: experimental group that carried out an educational program - 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last class, a booklet was delivered for each patient with all the contents of the classes and the Transcutaneous Nerve Electro-Stimulation device - being performed twice weekly, for 5 weeks for 40 minutes each session; and control group who only underwent treatment with the Transcutaneous Nerve Electro-Stimulation in the same parameters as experimental group. The evaluations were performed at the beginning of the treatment, 4 and 12 weeks after the beginning of the treatment using a numerical pain scale; WOMAC; IDATE and SF-36 questionnaires; and 6-minute walk test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    Education, Pain, Function, Quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Education Group
    Arm Type
    Experimental
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Educational Program
    Intervention Description
    Educational program consist in 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last class, a booklet was delivered for each patient with all the contents of the classes. This group also received Transcutaneous Nerve Electro-Stimulation twice weekly, for 5 weeks for 40 minutes each session
    Intervention Type
    Device
    Intervention Name(s)
    Transcutaneous Nerve Electro-Stimulation
    Intervention Description
    Transcutaneous Nerve Electro-Stimulation performed twice weekly, for 5 weeks for 40 minutes each session
    Primary Outcome Measure Information:
    Title
    Change in Pain
    Description
    Evaluated using a numeric pain scale
    Time Frame
    Baseline and after 4 and 12 weeks
    Secondary Outcome Measure Information:
    Title
    Change in function
    Description
    Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index
    Time Frame
    Baseline and after 4 and 12 weeks
    Title
    Change in Anxiety
    Description
    Evaluated using the Inventory Anxiety Trait Inventory - State
    Time Frame
    Baseline and after 4 and 12 weeks
    Title
    Change in Generic Quality of life
    Description
    Evaluated using the SF-36 questionnaire
    Time Frame
    Baseline and after 4 and 12 weeks
    Title
    Change in Functional capacity
    Description
    Evaluated with the six minute walk test
    Time Frame
    Baseline and after 4 and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of knee Osteoarthritis by American College of Rheumatology criteria; Age between 40 and 80 years; Both genders; Numerical Pain Scale in the knee between 3 and 8 centimeters on a scale of 0 to 10 centimeters. Exclusion Criteria: Systemic inflammatory diseases or any condition that prevents the practice of physical activity; Regular physical activity started or changed in the last twelve weeks; No ambulation; Joint injection in the knee in the previous twelve weeks; Previous knee surgery or surgery planned for the next twenty-four weeks; Physiotherapy in the last twelve weeks; Other disease that affects the lower limbs; Open wounds at the electrode application site; Planned trip in the next twelve weeks.

    12. IPD Sharing Statement

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    Educational Program for Knee Osteoarthritis

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