71
Participants
Start Date
March 15, 2022
Primary Completion Date
April 9, 2025
Study Completion Date
May 30, 2025
Clinical treatment and Knee educational program
"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."
Knee educational program
"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
Ministry of Health, Brazil
OTHER_GOV
Marta Imamura
OTHER