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Completed

NCT Number: NCT05286775

Knee Osteoarthritis Disabling Pain Program for the Brazilian Unified Health System

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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)

São Paulo, 04101-300, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical treatment and Knee educational program

Other

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.

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.

Primary outcomes

  1. Knee function

    Time frame: Baseline and up to six months from baseline.

    Change of knee function from baseline measured with Knee Injury and Osteoarthritis Outcome Score (KOOS)

Secondary outcomes

  1. Knee function

    Time frame: Baseline and up to three months from baseline.

    Change of knee function from baseline measured with Knee Injury and Osteoarthritis Outcome Score (KOOS)

  2. Knee pain as assessed by Visual Analogue Scale (VAS)

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    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.

  3. Quality of Life Assessment as assessed by 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.

    Change of Quality of Life from baseline measured with the 36-Item Short-Form Health Survey (SF-36)

  4. Physical activity level

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    Change of classification of physical activity level according to a physical activity level scale

  5. Pain pressure threshold

    Time frame: Baseline, end of treatment, and three months from end of treatment.

    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.

  6. Pain modulation

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    Change of conditioned pain modulation test of hands in cold water

  7. Bio-mechanical assessment (Steps)

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    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.

  8. Bio-mechanical assessment (Energy Expenditure)

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    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.

  9. Bio-mechanical assessment (Physical activity intensity)

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    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.

  10. Bio-mechanical assessment (Step velocity)

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    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.

  11. Gait analysis (gait cycle)

    Time frame: Baseline and up to three months from baseline.

    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.

  12. Gait analysis (joint angles)

    Time frame: Baseline and up to three months from baseline.

    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.

  13. Muscle strength (Work)

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    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).

  14. Muscle strength (Power)

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    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).

  15. Muscle strength (Peak torque)

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    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).

  16. Muscle strength (Agonist/Antagonist Balance)

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    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 %).

  17. Functional mobility

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    Change in functional mobility measured with the Timed Up and Go test (TUG)

  18. Cutaneous temperature

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    Change in cutaneous temperature of the knee with Infra-red thermography images.

Other outcomes

  1. Nutritional status

    Time frame: Baseline

    Nutritional status scale

  2. Body Mass Index

    Time frame: Baseline

    Body Mass Index (BMI): the ratio of weight divided by the squared height.

  3. Cognitive status

    Time frame: Baseline

    Cognitive status measured with Montreal Cognitive Assessment Test (MoCA)

  4. Electroencephalogram (EEG)

    Time frame: Baseline, up to three months from baseline, and up to six months from baseline.

    Change from baseline of neurophysiological parameters with an EEG system. The analyzed parameters will be absolute power (μV2) and relative power (power in a specific frequency range/total power from 1 to 40 Hz) for the frequency bands delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and the sub-bands: low beta (13-20 Hz) and high beta (20-30 Hz), measured at the central, parietal, and frontal areas.

  5. Magnetic Resonance Imaging (MRI)

    Time frame: Baseline

    Magnetic resonance imaging of the knees

  6. Demography

    Time frame: Baseline

    Demographic characteristics of participants, such as age, sex, schooling, body mass index (BMI), concomitant medical drug use, and comorbidities.

Sponsors and collaborators

Lead sponsor

Marta Imamura

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2022
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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