Clinical trial NCT05286775: Knee Osteoarthritis Disabling Pain Program for the Brazilian Unified Health System
Official title: The Functional Treatment of Disabling Pain in Knee Osteoarthritis in a Rehabilitation Program for the Brazilian Unified Health System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Physical and Rehabilitation Medicine
Knee Osteoarthritis
Pain
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2022-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Knee function
timeFrame: Baseline and up to six months from baseline.
Secondary outcomes:
measure: Knee function
timeFrame: Baseline and up to three months from baseline.
measure: Knee pain as assessed by Visual Analogue Scale (VAS)
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Quality of Life Assessment as assessed by the 36-Item Short-Form Health Survey (SF-36)
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Physical activity level
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Pain pressure threshold
timeFrame: Baseline, end of treatment, and three months from end of treatment.
measure: Pain modulation
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Bio-mechanical assessment (Steps)
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Bio-mechanical assessment (Energy Expenditure)
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Bio-mechanical assessment (Physical activity intensity)
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Bio-mechanical assessment (Step velocity)
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Gait analysis (gait cycle)
timeFrame: Baseline and up to three months from baseline.
measure: Gait analysis (joint angles)
timeFrame: Baseline and up to three months from baseline.
measure: Muscle strength (Work)
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Muscle strength (Power)
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Muscle strength (Peak torque)
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Muscle strength (Agonist/Antagonist Balance)
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Functional mobility
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Cutaneous temperature
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
Other outcomes:
measure: Nutritional status
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Baseline
measure: Cognitive status
timeFrame: Baseline
measure: Electroencephalogram (EEG)
timeFrame: Baseline, up to three months from baseline, and up to six months from baseline.
measure: Magnetic Resonance Imaging (MRI)
timeFrame: Baseline
measure: Demography
timeFrame: Baseline
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Medicina Física e Reabilitação (IMREA-FMUSP)
Study officials:
affiliation: University of Sao Paulo
name: Marta Imamura, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: