Educational Program for Knee Osteoarthritis

July 24, 2018 updated by: Anamaria Jones, Federal University of São Paulo

Evaluation of the Effectiveness of an Educational Program in Patients With Osteoarthritis of the Knee: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Device: Transcutaneous Nerve Electro-Stimulation
Transcutaneous Nerve Electro-Stimulation performed twice weekly, for 5 weeks for 40 minutes each session
Experimental: Education Group
Other: Educational Program
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
Device: Transcutaneous Nerve Electro-Stimulation
Transcutaneous Nerve Electro-Stimulation performed twice weekly, for 5 weeks for 40 minutes each session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain
Time Frame: Baseline and after 4 and 12 weeks
Evaluated using a numeric pain scale
Baseline and after 4 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in function
Time Frame: Baseline and after 4 and 12 weeks
Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index
Baseline and after 4 and 12 weeks
Change in Anxiety
Time Frame: Baseline and after 4 and 12 weeks
Evaluated using the Inventory Anxiety Trait Inventory - State
Baseline and after 4 and 12 weeks
Change in Generic Quality of life
Time Frame: Baseline and after 4 and 12 weeks
Evaluated using the SF-36 questionnaire
Baseline and after 4 and 12 weeks
Change in Functional capacity
Time Frame: Baseline and after 4 and 12 weeks
Evaluated with the six minute walk test
Baseline and after 4 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

October 24, 2017

Study Completion (Actual)

June 17, 2018

Study Registration Dates

First Submitted

July 4, 2018

First Submitted That Met QC Criteria

July 4, 2018

First Posted (Actual)

July 17, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP UNIFESP 458293

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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