Knee Osteoarthritis Disabling Pain Program for the Brazilian Unified Health System

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286775
• Other study ID #: 08756819.8.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: University of Sao Paulo
• Contact: Marta Imamura, MD PhD
• Phone: 55-11-5180-7897
• Email: marta.imamura[@]fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Clinical treatment and Knee educational program
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
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.

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Marta Imamura	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nutritional status	Nutritional status scale	Baseline
Other	Body Mass Index	Body Mass Index (BMI): the ratio of weight divided by the squared height.	Baseline
Other	Cognitive status	Cognitive status measured with Montreal Cognitive Assessment Test (MoCA)	Baseline
Other	Electroencephalogram (EEG)	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.	Baseline, up to three months from baseline, and up to six months from baseline.
Other	Magnetic Resonance Imaging (MRI)	Magnetic resonance imaging of the knees	Baseline
Other	Demography	Demographic characteristics of participants, such as age, sex, schooling, body mass index (BMI), concomitant medical drug use, and comorbidities.	Baseline
Primary	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	Knee function	Change of knee function from baseline measured with Knee Injury and Osteoarthritis Outcome Score (KOOS)	Baseline and up to three months from baseline.
Secondary	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.	Baseline, up to three months from baseline, and up to six months from baseline.
Secondary	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)	Baseline, up to three months from baseline, and up to six months from baseline.
Secondary	Physical activity level	Change of classification of physical activity level according to a physical activity level scale	Baseline, up to three months from baseline, and up to six months from baseline.
Secondary	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.	Baseline, end of treatment, and three months from end of treatment.
Secondary	Pain modulation	Change of conditioned pain modulation test of hands in cold water	Baseline, up to three months from baseline, and up to six months from baseline.
Secondary	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.	Baseline, up to three months from baseline, and up to six months from baseline.
Secondary	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.	Baseline, up to three months from baseline, and up to six months from baseline.
Secondary	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.	Baseline, up to three months from baseline, and up to six months from baseline.
Secondary	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.	Baseline, up to three months from baseline, and up to six months from baseline.
Secondary	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.	Baseline and up to three months from baseline.
Secondary	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.	Baseline and up to three months from baseline.
Secondary	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).	Baseline, up to three months from baseline, and up to six months from baseline.
Secondary	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).	Baseline, up to three months from baseline, and up to six months from baseline.
Secondary	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).	Baseline, up to three months from baseline, and up to six months from baseline.
Secondary	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 %).	Baseline, up to three months from baseline, and up to six months from baseline.
Secondary	Functional mobility	Change in functional mobility measured with the Timed Up and Go test (TUG)	Baseline, up to three months from baseline, and up to six months from baseline.
Secondary	Cutaneous temperature	Change in cutaneous temperature of the knee with Infra-red thermography images.	Baseline, up to three months from baseline, and up to six months from baseline.