Knee Osteoarthritis Disabling Pain Program for the Brazilian Unified Health System
- Conditions
- Osteoarthritis, Knee
- Interventions
- Other: Clinical treatment and Knee educational programOther: Knee educational program
- Registration Number
- NCT05286775
- Lead Sponsor
- Marta Imamura
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clinical treatment and Knee educational program Clinical treatment and Knee educational program Medical knee treatment combined with knee educational educational program Knee educational program Clinical treatment and Knee educational program Knee educational program Knee educational program Knee educational program Knee educational program
- Primary Outcome Measures
Name Time Method Knee function Baseline and up to six months from baseline. Change of knee function from baseline measured with Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Secondary Outcome Measures
Name Time Method Knee pain as assessed by Visual Analogue Scale (VAS) Baseline, up to three months from baseline, and up to six months from baseline. Change of knee pain from baseline measured with Visual Analogue Scale (VAS), a 0 - 10 rating scale in which 0 means no pain and 10 means the worst pain possible.
Gait analysis (joint angles) Baseline and up to three months from baseline. Change of gait parameters measured by a three-dimensional gait analysis system in a gait analysis lab. Ten Infra-red cameras will detect gait parameters and a platform will detect the different pressures delivered by both lower limbs during gait. Bilateral joint angles (degrees) will be collected and analyzed.
Knee function Baseline and up to three months from baseline. Change of knee function from baseline measured with Knee Injury and Osteoarthritis Outcome Score (KOOS)
Physical activity level Baseline, up to three months from baseline, and up to six months from baseline. Change of classification of physical activity level according to a physical activity level scale
Pain pressure threshold Baseline, end of treatment, and three months from end of treatment. Change of pain pressure threshold measured bilaterally with an algometer, at vastus medialis, adductor longus, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, iliacus, sartorius, gracilis, quadratus lumborum, popliteus, and ligaments located over the supraspinous ligaments between L1-L2, L2-L3, L3-L4, L4-L5, L5-S1 and sacral (S) areas S1-S2.
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. Change of Quality of Life from baseline measured with the 36-Item Short-Form Health Survey (SF-36)
Pain modulation Baseline, up to three months from baseline, and up to six months from baseline. Change of conditioned pain modulation test of hands in cold water
Bio-mechanical assessment (Steps) Baseline, up to three months from baseline, and up to six months from baseline. Change of bio-mechanic variables, assessment with a wearable three axial accelerometer. The patients will wear an accelerometer (Actigraph) for one week before all evaluation time points. Daily data on number of steps will be collected.
Bio-mechanical assessment (Energy Expenditure) Baseline, up to three months from baseline, and up to six months from baseline. Change of bio-mechanic variables, assessment with a wearable three axial accelerometer. The patients will wear an accelerometer (Actigraph) for one week before all evaluation time points. Daily data on energy expenditure (kcal) will be collected.
Bio-mechanical assessment (Physical activity intensity) Baseline, up to three months from baseline, and up to six months from baseline. Change of bio-mechanic variables, assessment with a wearable three axial accelerometer. The patients will wear an accelerometer (Actigraph) for one week before all evaluation time points. Daily data on physical activity intensity will be collected.
Gait analysis (gait cycle) Baseline and up to three months from baseline. Change of gait parameters measured by a three-dimensional gait analysis system in a gait analysis lab. Ten Infra-red cameras will detect gait parameters and a platform will detect the different pressures delivered by both lower limbs during gait. Bilateral gait cycle (seconds) will be collected, compared and analyzed.
Bio-mechanical assessment (Step velocity) Baseline, up to three months from baseline, and up to six months from baseline. Change of bio-mechanic variables, assessment with a wearable three axial accelerometer. The patients will wear an accelerometer (Actigraph) for one week before all evaluation time points. Daily data on step velocity (steps/second) will be collected.
Muscle strength (Work) Baseline, up to three months from baseline, and up to six months from baseline. Change in muscle strength (knee flexion and extension) measured by an isokinetic dynamometry (Cybex), at 60º and 120º per second. The analyzed variables will be work (Joules - J).
Muscle strength (Agonist/Antagonist Balance) Baseline, up to three months from baseline, and up to six months from baseline. Change in muscle strength (knee flexion and extension) measured by an isokinetic dynamometry (Cybex), at 60º and 120º per second. The analyzed variables will be agonist/antagonist balance of knee flexion and extension (difference of strength between agonist/antagonist in %).
Cutaneous temperature Baseline, up to three months from baseline, and up to six months from baseline. Change in cutaneous temperature of the knee with Infra-red thermography images.
Muscle strength (Power) Baseline, up to three months from baseline, and up to six months from baseline. Change in muscle strength (knee flexion and extension) measured by an isokinetic dynamometry (Cybex), at 60º and 120º per second. The analyzed variables will be Power (Watts - W).
Muscle strength (Peak torque) Baseline, up to three months from baseline, and up to six months from baseline. Change in muscle strength (knee flexion and extension) measured by an isokinetic dynamometry (Cybex), at 60º and 120º per second. The analyzed variables will be bilateral Peak tork (Newton meters - Nm).
Functional mobility Baseline, up to three months from baseline, and up to six months from baseline. Change in functional mobility measured with the Timed Up and Go test (TUG)
Trial Locations
- Locations (1)
Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)
🇧🇷São Paulo, Brazil