Knee Osteoarthritis Disabling Pain Program for the Brazilian Unified Health System

NCT ID: NCT05286775

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2025-05-30

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Clinical treatment and Knee educational program

Medical knee treatment combined with knee educational educational program

Group Type: EXPERIMENTAL

Clinical treatment and Knee educational program

Intervention Type: OTHER

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

Knee educational program

Group Type: ACTIVE_COMPARATOR

Clinical treatment and Knee educational program

Intervention Type: OTHER

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

Marta Imamura

OTHER

Sponsor Role: lead

Responsible Party

Marta Imamura

MD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marta Imamura, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

08756819.8.0000.0068

Identifier Type: -

Identifier Source: org_study_id