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OpenTrials
Completed

NCT Number: NCT03588195

Educational Program for Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational program

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

Device

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

Primary outcomes

  1. Change in Pain

    Time frame: Baseline and after 4 and 12 weeks

    Evaluated using a numeric pain scale

Secondary outcomes

  1. Change in function

    Time frame: Baseline and after 4 and 12 weeks

    Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index

  2. Change in Anxiety

    Time frame: Baseline and after 4 and 12 weeks

    Evaluated using the Inventory Anxiety Trait Inventory - State

  3. Change in Generic Quality of life

    Time frame: Baseline and after 4 and 12 weeks

    Evaluated using the SF-36 questionnaire

  4. Change in Functional capacity

    Time frame: Baseline and after 4 and 12 weeks

    Evaluated with the six minute walk test

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 17, 2018
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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