Educational Program for Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Educational Program; Device: Transcutaneous Nerve Electro-Stimulation

• Registration Number: NCT03588195
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Primary Completion: 2017-10-24
• Study Completion: 2018-06-17
• Status Verified: 2018-07
• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-04
• Study First Posted: 2018-07-17
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education Group	Transcutaneous Nerve Electro-Stimulation	-
Education Group	Educational Program	-
Control Group	Transcutaneous Nerve Electro-Stimulation	-

Primary Outcome Measures

Name	Time	Method
Change in Pain	Baseline and after 4 and 12 weeks	Evaluated using a numeric pain scale

Secondary Outcome Measures

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