Educational Program for Knee Osteoarthritis

NCT ID: NCT03588195

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2018-06-17

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Education Group

Group Type: EXPERIMENTAL

Educational Program

Intervention Type: OTHER

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

Transcutaneous Nerve Electro-Stimulation

Intervention Type: DEVICE

Transcutaneous Nerve Electro-Stimulation performed twice weekly, for 5 weeks for 40 minutes each session

Control Group

Group Type: ACTIVE_COMPARATOR

Transcutaneous Nerve Electro-Stimulation

Intervention Type: DEVICE

Transcutaneous Nerve Electro-Stimulation performed twice weekly, for 5 weeks for 40 minutes each session

Interventions

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

Intervention Type: OTHER

Transcutaneous Nerve Electro-Stimulation

Transcutaneous Nerve Electro-Stimulation performed twice weekly, for 5 weeks for 40 minutes each session

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Anamaria Jones

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CEP UNIFESP 458293

Identifier Type: -

Identifier Source: org_study_id