Clinical trial NCT06187038: Effects of Including a Chronic Pain Neuroscience Education Program for Individuals With Knee OA
Official title: Effects of Including a Chronic Pain Neuroscience Education Program for Individuals With Knee OA: Randomized, Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Research participants diagnosed with knee osteoarthritis will be randomized through a draw using sealed opaque envelopes indicating two groups: 1. therapeutic exercises, 2. therapeutic exercises + chronic pain neuroscience education program. The primary outcome will be functional performance using a patient-reported measure, the Knee Injury and Osteoarthritis Outcome Score (KOOS).

The selected secondary outcomes will be pain intensity by the numerical pain scale (END), physical function reported by the patient by the patient-specific functional scale (EFEP), Pain self-efficacy questionnaire (PSEQ), functional mobility by the timed up and test (TUG), general effect perceived through the global perception scale (EPG), muscle strength through Maximum Voluntary Isometric Contraction (MVIC) and functionality and disability through the World Health Organization Disability Assessment Schedule (WHODAS).


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of knee osteoarthritis (knee pain for \> 3 months
* Morning stiffness \<30 minutes
* Crepitus
* Bone tenderness, and absence of palpable heat and/or diagnosis established radiographically (determined by Kellgren and Lawrence grade 1 to 3 on a scale 1 up to 4)

Exclusion Criteria:

* Hip OA
* severe osteoporosis
* Fibromyalgia
* Medical history of tumors or cancer
* Active inflammatory joint diseases (rheumatoid arthritis, gout)
* Undergoing any lower extremity joint replacement
* Neurological diseases (Parkinson's disease, stroke, Multiple Sclerosis, muscular dystrophy, motor neuron disease, Alzheimer's disease, cognitive and cardiopulmonary impairment that may prevent or limit the performance of exercises, use of a gait assistance device, history of recent knee trauma.
* Having undergone any form of treatment involving physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotective in the last six months

Primary outcomes:
measure: Functional disability
timeFrame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
Secondary outcomes:
measure: Numerical Pain Scale
timeFrame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
measure: Functional self-perception
timeFrame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
measure: Self-perceived functionality
timeFrame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
measure: Maximum voluntary isometric contraction
timeFrame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
measure: Dynamic balance
timeFrame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
measure: Global Perception of Change scale
timeFrame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
measure: Functionality
timeFrame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University
Study officials:
affiliation: Nove de Julho University
name: Cid Gomes, PhD
role: PRINCIPAL_INVESTIGATOR
References: