Educational Program for Knee Osteoarthritis

Study Overview
=================
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.

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

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Other: Educational Program
* Device: Transcutaneous Nerve Electro-Stimulation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of life, Education, Pain, Function