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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical treatment and Knee educational program | Experimental | Medical knee treatment combined with knee educational educational program |
|
| Knee educational program | Active Comparator | Knee educational program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical treatment and Knee educational program | Other | Three weekly medical interventions, according to the patient's need as observed at baseline.
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee function | Change of knee function from baseline measured with Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline and up to six months from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee function | Change of knee function from baseline measured with Knee Injury and Osteoarthritis Outcome Score (KOOS) | Baseline and up to three months from baseline. |
| Knee pain as assessed by Visual Analogue Scale (VAS) |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status | Nutritional status scale | Baseline |
| Body Mass Index | Body Mass Index (BMI): the ratio of weight divided by the squared height. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Imamura, MD PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Medicina Física e Reabilitação (IMREA-FMUSP) | São Paulo | São Paulo | 04101-300 | Brazil |
Individual Participant Data (IPD) may be shared in the future under suitable request and justification to principal investigator.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Knee educational program | Other | Three weekly 60-minute educational program sessions with the following services: Stretching and strengthening exercises for specific muscle groups (hip flexors, extensors, and abductors; knee flexors and extensors; plantar flexors; and abdominal muscles), using one's own body and gravity resistance. Patients will be encouraged to practice them at home at least twice a week after the end of the sessions. Nutritional guidance: Instructions on the importance of adequate weight management, healthy food consumption, and the adequate intake of nutrients. Physical activities: Counseling on home-based physical activities, according to their physical capacities, to protect knee joints. General health: psychology counseling, encouraging participants to apply strategies and self help conduct to improve their general health; Occupational Therapy: Activities of Daily Living strategies to protect knee joints; Nursing: Counseling on strategies for improving healthy sleeping habits. |
|
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.
| Baseline, up to three months from baseline, and up to six months from baseline. |
| Quality of Life Assessment as assessed by the 36-Item Short-Form Health Survey (SF-36) | Change of Quality of Life from baseline measured with the 36-Item Short-Form Health Survey (SF-36) | Baseline, up to three months from baseline, and up to six months from baseline. |
| Physical activity level | Change of classification of physical activity level according to a physical activity level scale | Baseline, up to three months from baseline, and up to six months from baseline. |
| Pain pressure threshold | 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. | Baseline, end of treatment, and three months from end of treatment. |
| Pain modulation | Change of conditioned pain modulation test of hands in cold water | Baseline, up to three months from baseline, and up to six months from baseline. |
| Bio-mechanical assessment (Steps) | 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. | Baseline, up to three months from baseline, and up to six months from baseline. |
| Bio-mechanical assessment (Energy Expenditure) | 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. | Baseline, up to three months from baseline, and up to six months from baseline. |
| Bio-mechanical assessment (Physical activity intensity) | 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. | Baseline, up to three months from baseline, and up to six months from baseline. |
| Bio-mechanical assessment (Step velocity) | 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. | Baseline, up to three months from baseline, and up to six months from baseline. |
| Gait analysis (gait cycle) | 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. | Baseline and up to three months from baseline. |
| Gait analysis (joint angles) | 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. | Baseline and up to three months from baseline. |
| Muscle strength (Work) | 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). | Baseline, up to three months from baseline, and up to six months from baseline. |
| Muscle strength (Power) | 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). | Baseline, up to three months from baseline, and up to six months from baseline. |
| Muscle strength (Peak torque) | 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). | Baseline, up to three months from baseline, and up to six months from baseline. |
| Muscle strength (Agonist/Antagonist Balance) | 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 %). | Baseline, up to three months from baseline, and up to six months from baseline. |
| Functional mobility | Change in functional mobility measured with the Timed Up and Go test (TUG) | Baseline, up to three months from baseline, and up to six months from baseline. |
| Cutaneous temperature | Change in cutaneous temperature of the knee with Infra-red thermography images. | Baseline, up to three months from baseline, and up to six months from baseline. |
| Baseline |
| Cognitive status | Cognitive status measured with Montreal Cognitive Assessment Test (MoCA) | Baseline |
| Electroencephalogram (EEG) | Change from baseline of neurophysiological parameters with an EEG system. The analyzed parameters will be absolute power (μV2) and relative power (power in a specific frequency range/total power from 1 to 40 Hz) for the frequency bands delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and the sub-bands: low beta (13-20 Hz) and high beta (20-30 Hz), measured at the central, parietal, and frontal areas. | Baseline, up to three months from baseline, and up to six months from baseline. |
| Magnetic Resonance Imaging (MRI) | Magnetic resonance imaging of the knees | Baseline |
| Demography | Demographic characteristics of participants, such as age, sex, schooling, body mass index (BMI), concomitant medical drug use, and comorbidities. | Baseline |
| D012216 |
| Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |