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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
71
Three weekly medical interventions, according to the patient's need as observed at baseline. 1. 3ml paraspinal infusion of 1% Lidocaine (segmental spinal level); 2. 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; 3. \*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: 4. Ultrasound guided genicular nerve block: infusion of up to 10ml 0.50% Levobupivacaine without vasoconstrictor; 5. Hydrodissection of superficial and deep plane nerves: infusion of 10ml 5% dextrose diluted in water (D5W); 6. Intra-articular Infusion of Hyaluronic Acid: ultrasound guided infusion of 2.5ml of sodium hyaluronate at the knee joint. * Four weekly applications.
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.
Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)
São Paulo, São Paulo, Brazil
Knee function
Change of knee function from baseline measured with Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline and up to six months from baseline.
Knee function
Change of knee function from baseline measured with Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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.
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Time frame: Baseline, end of treatment, and three months from end of treatment.
Pain modulation
Change of conditioned pain modulation test of hands in cold water
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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 %).
Time frame: 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)
Time frame: 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.
Time frame: Baseline, up to three months from baseline, and up to six months from baseline.