Educational Program for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03588195
• Other study ID #: CEP UNIFESP 458293
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: June 17, 2018

Study information

• Verified date: July 2018
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 17, 2018
• Est. primary completion date: October 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain	Evaluated using a numeric pain scale	Baseline and after 4 and 12 weeks
Secondary	Change in function	Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index	Baseline and after 4 and 12 weeks
Secondary	Change in Anxiety	Evaluated using the Inventory Anxiety Trait Inventory - State	Baseline and after 4 and 12 weeks
Secondary	Change in Generic Quality of life	Evaluated using the SF-36 questionnaire	Baseline and after 4 and 12 weeks
Secondary	Change in Functional capacity	Evaluated with the six minute walk test	Baseline and after 4 and 12 weeks