Knee Osteoarthritis Disabling Pain Program for the Brazilian Unified Health System

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Clinical treatment and Knee educational program
* Other: Knee educational program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical treatment and Knee educational program<br>Medical knee treatment combined with knee educational educational program | Other: Clinical treatment and Knee educational program<br>* Three weekly medical interventions, according to the patient's need as observed at baseline. 3ml paraspinal infusion of 1% Lidocaine (segmental spinal level); 5,000 impulses of Radial Shockwave Therapy (pneumatic generator, 0.16mJ/mm² of energy and 20Hz of frequency) at the most painful spot of the knees; *6,000 pulses of Focused Shockwave Therapy (electromagnetic generator) at four sites of the painful knee. For those with knee pain of 7 or above in Visual Analogue Scale after the treatments above, the interventions below will be delivered in the order they appear: Ultrasound guided genicular nerve block: infusion of up to 10ml 0.50% Levobupivacaine without vasoconstrictor; Hydrodissection of superficial and deep plane nerves: infusion of 10ml 5% dextrose diluted in water (D5W); Intra-articular Infusion of Hyaluronic Acid: ultrasound guided infusion of 2.5ml of sodium hyaluronate at the knee joint. Four weekly applications.<br>|
| Active Comparator: Knee educational program<br>Knee educational program | Other: Clinical treatment and Knee educational program<br>* Three weekly medical interventions, according to the patient's need as observed at baseline. 3ml paraspinal infusion of 1% Lidocaine (segmental spinal level); 5,000 impulses of Radial Shockwave Therapy (pneumatic generator, 0.16mJ/mm² of energy and 20Hz of frequency) at the most painful spot of the knees; *6,000 pulses of Focused Shockwave Therapy (electromagnetic generator) at four sites of the painful knee. For those with knee pain of 7 or above in Visual Analogue Scale after the treatments above, the interventions below will be delivered in the order they appear: Ultrasound guided genicular nerve block: infusion of up to 10ml 0.50% Levobupivacaine without vasoconstrictor; Hydrodissection of superficial and deep plane nerves: infusion of 10ml 5% dextrose diluted in water (D5W); Intra-articular Infusion of Hyaluronic Acid: ultrasound guided infusion of 2.5ml of sodium hyaluronate at the knee joint. Four weekly applications.<br>Other: Knee educational program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical and Rehabilitation Medicine, Knee Osteoarthritis, Pain