Osteoarthritis, KneeNCT05286775
Knee Osteoarthritis Disabling Pain Program for the Brazilian Unified Health System
A study testing Clinical treatment and Knee educational program and Knee educational program in people with Osteoarthritis, Knee, run by Marta Imamura at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Clinical treatment and Knee educational program and Knee educational program
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Mar 2022to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)
São Paulo, São Paulo, 04101-300
About this study
Official title: The Functional Treatment of Disabling Pain in Knee Osteoarthritis in a Rehabilitation 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Clinical treatment and Knee educational program, Knee educational program
- Keywords
- Physical and Rehabilitation Medicine, Knee Osteoarthritis, Pain
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical treatment and Knee educational programOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical treatment and Knee educational program | Experimental | Medical knee treatment combined with knee educational educational program Receives: Other: Clinical treatment and Knee educational program |
| Knee educational program | Active comparator | Knee educational program Receives: Other: Clinical treatment and Knee educational program; Other: Knee educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee function
Change of knee function from baseline measured with Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: Baseline and up to six months from baseline.
Secondary outcomes (18)
Knee function
Change of knee function from baseline measured with Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: Baseline, end of treatment, and three months from end of treatment.
Pain modulation
Change of conditioned pain modulation test of hands in cold water
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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 %).
Measured: 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)
Measured: 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.
Measured: Baseline, up to three months from baseline, and up to six months from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start15 Mar 2022
- Primary completion9 Apr 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marta Imamura
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Sponsor-investigator, Marta Imamura, University of Sao Paulo
- Investigators
- Marta Imamura, MD PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286775
- Sponsor's protocol ID
- 08756819.8.0000.0068
- Status last verified
- Aug 2025
- First submitted
- 11 Feb 2022
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data (IPD) may be shared in the future under suitable request and justification to principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Functional Treatment of Disabling Pain in Knee Osteoarthritis in a Rehabilitation Program for the Brazilian Unified Health System
- ClinicalTrials.gov ID
- NCT05286775
- Acronym / sponsor ID
- 08756819.8.0000.0068
- Conditions
- Osteoarthritis, Knee
- Keywords
- Physical and Rehabilitation Medicine, Knee Osteoarthritis, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Marta ImamuraUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical treatment and Knee educational program | Experimental | Other: Clinical treatment and Knee educational programMedical knee treatment combined with knee educational educational program |
| Knee educational program | Active comparator | Other: Clinical treatment and Knee educational program, Other: Knee educational programKnee educational program |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical treatment and Knee educational programThree 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. | Other | Clinical treatment and Knee educational program, Knee educational program |
| Knee educational programThree 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. | Other | Knee educational program |
Primary outcome
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)
18 secondary outcomes
Knee function
Time frame: Baseline and up to three months from baseline.
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.
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.
Physical activity level
Time frame: Baseline, up to three months from baseline, and up to six months from baseline.
Pain pressure threshold
Time frame: Baseline, end of treatment, and three months from end of treatment.
Pain modulation
Time frame: Baseline, up to three months from baseline, and up to six months from baseline.
Bio-mechanical assessment (Steps)
Time frame: Baseline, up to three months from baseline, and up to six months from baseline.
Bio-mechanical assessment (Energy Expenditure)
Time frame: Baseline, up to three months from baseline, and up to six months from baseline.
Bio-mechanical assessment (Physical activity intensity)
Time frame: Baseline, up to three months from baseline, and up to six months from baseline.
Bio-mechanical assessment (Step velocity)
Time frame: Baseline, up to three months from baseline, and up to six months from baseline.
Gait analysis (gait cycle)
Time frame: Baseline and up to three months from baseline.
Gait analysis (joint angles)
Time frame: Baseline and up to three months from baseline.
Muscle strength (Work)
Time frame: Baseline, up to three months from baseline, and up to six months from baseline.
Muscle strength (Power)
Time frame: Baseline, up to three months from baseline, and up to six months from baseline.
Muscle strength (Peak torque)
Time frame: Baseline, up to three months from baseline, and up to six months from baseline.
Muscle strength (Agonist/Antagonist Balance)
Time frame: Baseline, up to three months from baseline, and up to six months from baseline.
Functional mobility
Time frame: Baseline, up to three months from baseline, and up to six months from baseline.
Cutaneous temperature
Time frame: Baseline, up to three months from baseline, and up to six months from baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Undecided. Individual Participant Data (IPD) may be shared in the future under suitable request and justification to principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Imamura, MD PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical treatment and Knee educational program and Knee educational program in people with Osteoarthritis, Knee, run by Marta Imamura at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee function (time frame: Baseline and up to six months from baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.