Chronic pain education program for knee osteoarthritis
Effects of Including a Chronic Pain Neuroscience Education Program for Individuals With Knee OA: Randomized, Blinded Clinical Trial
This study is testing if adding a chronic pain education program to exercise can help people with knee osteoarthritis feel better and move more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | University of Nove de Julho Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06187038 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a chronic pain neuroscience education program combined with therapeutic exercises for individuals diagnosed with knee osteoarthritis. Participants will be randomly assigned to either a group receiving only therapeutic exercises or a group receiving both therapeutic exercises and the education program. The primary outcome will focus on functional performance as measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS), while secondary outcomes will assess pain intensity, physical function, pain self-efficacy, functional mobility, perceived general effect, muscle strength, and overall functionality and disability. The goal is to determine if the education program enhances the benefits of therapeutic exercises.
Who should consider this trial
Good fit: Ideal candidates are individuals with a clinical diagnosis of knee osteoarthritis experiencing knee pain for more than three months.
Not a fit: Patients with conditions such as hip osteoarthritis, severe osteoporosis, or active inflammatory joint diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve functional performance and pain management for patients with knee osteoarthritis.
How similar studies have performed: Other studies have shown positive outcomes with similar educational approaches in managing chronic pain, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
São Paulo
- Nove de Julho University — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Cid Gomes, PhD — Nove de Julho University
- Study coordinator: Cid Gomes, PhD
- Email: cid.andre@gmail.com
- Phone: +5511970941936
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.