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Recruiting NCT06187038

Effects of Including a Chronic Pain Neuroscience Education Program for Individuals With Knee OA

No phase Interventional Osteoarthritis, Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Therapeutic exercises, Therapeutic exercises + pain neuroscience education program.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Including a Chronic Pain Neuroscience Education Program for Individuals With Knee OA: Randomized, Blinded Clinical Trial

Overview

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).

Interventions

  • Other Therapeutic exercises
    The therapeutic exercise program will include warm-up, resistance, neuromuscular, mobility, and balance exercises. Over ten weeks, two sessions of the therapeutic exercise program will be carried out individually, lasting approximately 60 minutes each-a total of 20 therapeutic exercise sessions. Therapeutic exercise sessions will be carried out at least 24 hours between sessions. Therapeutic exercises will be performed in up to three sets of 8-12 repetitions or 30-60 seconds each, with rest inte
  • Other Therapeutic exercises + pain neuroscience education program
    In addition to the therapeutic exercise protocol previously reported in the control group, research participants allocated to the experimental group will undergo an education program in the neurosciences of chronic pain carried out one day a week between the two therapeutic exercise sessions lasting ten weeks. The chronic pain neuroscience education program will be based on three domains. Making sense of pain, Exposure with control, and Lifestyle changes also urge modifications aimed at improvi

Primary outcome measures

  • Functional disability [Time frame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.]
Secondary outcome measures (7)
  • Numerical Pain Scale [Time frame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.]
  • Functional self-perception [Time frame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.]
  • Self-perceived functionality [Time frame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.]
  • Maximum voluntary isometric contraction [Time frame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.]
  • Dynamic balance [Time frame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.]
  • Global Perception of Change scale [Time frame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.]
  • Functionality [Time frame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Brazil · 1 center
  • Nove de Julho University — São Paulo

Identifiers

NCT: NCT06187038 · 70408123.1.0000.5511

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗