The Functional Treatment of Disabling Pain in Knee Osteoarthritis in a Rehabilitation Program for the Brazilian Unified Health System

Marta Imamura1 site in 1 country71 target enrollmentMarch 15, 2022

ConditionsOsteoarthritis, Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: Marta Imamura
Enrollment: 71
Locations: 1
Primary Endpoint: Knee function
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Randomized Clinical Trial to compare two interventions for reducing knee pain and improving knee function of patients with knee osteoarthritis.

Sixty participants will be randomly allocated to one of the intervention groups, either a knee educational program or a combination of knee educational program and medical interventions.

Participants will be assessed primarily on function and pain, as well as other secondary outcomes at baseline, at the end of the interventions, and three months after the end of the interventions.

Registry

clinicaltrials.gov

Start Date

March 15, 2022

End Date

May 30, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Marta Imamura

Responsible Party

Sponsor Investigator

Principal Investigator

Marta Imamura

MD PhD

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

•Clinical diagnosis of knee osteoarthritis;
•Moderate to severe knee pain (VAS \>= 4);
•Knee pain for at least 3 months prior to inclusion;
•Willing to sign the Informed Consent Form.

Exclusion Criteria

•Untreated severe psychological or psychiatric diseases without treatment;
•Presence of fibromyalgia;
•Presence of systemic inflammatory rheumatic diseases;
•Presence of neoplasia;
•Presence of relevant pain in other joints, according to medical evaluation;
•Presence of intolerance or allergy to Lidocaine or local anaesthetics;
•Concomitant use of anticoagulant drug.

Outcomes

Primary Outcomes

Knee function

Time Frame: Baseline and up to six months from baseline.

Change of knee function from baseline measured with Knee Injury and Osteoarthritis Outcome Score (KOOS)

Secondary Outcomes

Knee pain as assessed by Visual Analogue Scale (VAS)(Baseline, up to three months from baseline, and up to six months from baseline.)
Gait analysis (joint angles)(Baseline and up to three months from baseline.)
Knee function(Baseline and up to three months from baseline.)
Physical activity level(Baseline, up to three months from baseline, and up to six months from baseline.)
Pain pressure threshold(Baseline, end of treatment, and three months from end of treatment.)
Quality of Life Assessment as assessed by the 36-Item Short-Form Health Survey (SF-36)(Baseline, up to three months from baseline, and up to six months from baseline.)
Pain modulation(Baseline, up to three months from baseline, and up to six months from baseline.)
Bio-mechanical assessment (Steps)(Baseline, up to three months from baseline, and up to six months from baseline.)
Bio-mechanical assessment (Energy Expenditure)(Baseline, up to three months from baseline, and up to six months from baseline.)
Bio-mechanical assessment (Physical activity intensity)(Baseline, up to three months from baseline, and up to six months from baseline.)
Gait analysis (gait cycle)(Baseline and up to three months from baseline.)
Bio-mechanical assessment (Step velocity)(Baseline, up to three months from baseline, and up to six months from baseline.)
Muscle strength (Work)(Baseline, up to three months from baseline, and up to six months from baseline.)
Muscle strength (Agonist/Antagonist Balance)(Baseline, up to three months from baseline, and up to six months from baseline.)
Cutaneous temperature(Baseline, up to three months from baseline, and up to six months from baseline.)
Muscle strength (Power)(Baseline, up to three months from baseline, and up to six months from baseline.)
Muscle strength (Peak torque)(Baseline, up to three months from baseline, and up to six months from baseline.)
Functional mobility(Baseline, up to three months from baseline, and up to six months from baseline.)