Knee Osteoarthritis Disabling Pain Program for the Brazilian Unified Health System

NCT05286775 | Completed DMC

• 1 other identifier: 08756819.8.0000.0068
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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

Keywords

Physical and Rehabilitation Medicine; Knee Osteoarthritis; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Knee function

  Baseline and up to three months from baseline.

• Knee pain as assessed by Visual Analogue Scale (VAS)

  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)

  Baseline, up to three months from baseline, and up to six months from baseline.

• Physical activity level

  Baseline, up to three months from baseline, and up to six months from baseline.

• Pain pressure threshold

  Baseline, end of treatment, and three months from end of treatment.

Other Outcomes (6)

• Nutritional status

  Baseline

• Body Mass Index

  Baseline

• Cognitive status

  Baseline

Study Arms (2)

Clinical treatment and Knee educational program

EXPERIMENTAL

Medical knee treatment combined with knee educational educational program

Other: Clinical treatment and Knee educational program

Knee educational program

ACTIVE COMPARATOR

Knee educational program

Other: Clinical treatment and Knee educational program; Other: Knee educational program

Interventions

Clinical treatment and Knee educational program 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.

Clinical treatment and Knee educational program; Knee educational program

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.

Knee educational program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of knee osteoarthritis;
• Moderate to severe knee pain (VAS \>= 4);
• Willing to sign the Informed Consent Form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marta Imamura: lead
• Ministry of Health, Brazil: collaborator

Study Sites (1)

Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)

São Paulo, São Paulo, 04101-300, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marta Imamura, MD PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 18, 2022
• Study Start: March 15, 2022
• Primary Completion: April 9, 2025
• Study Completion: May 30, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

BR (1)