Effects of Including a Chronic Pain Neuroscience Education Program for Individuals With Knee OA
NCT ID: NCT06187038
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-05-28
2028-12-01
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Therapeutic exercise group
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. The therapeutic exercises will be performed in up to three sets of 8-12 repetitions or 30-60 seconds each, with rest intervals of 90 seconds between sets.
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 intervals of 90 seconds between sets.
Therapeutic exercise group and pain neuroscience education program
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. The therapeutic exercises will be performed in up to three sets of 8-12 repetitions or 30-60 seconds each, with rest intervals of 90 seconds between sets. The chronic pain neuroscience education program will be based on three domains. Making sense of pain, exposure with control, and lifestyle changes.
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 intervals of 90 seconds between sets.
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 improving sleep, stress, and anxiety.
Interventions
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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 intervals of 90 seconds between sets.
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 improving sleep, stress, and anxiety.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
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University of Nove de Julho
OTHER
Responsible Party
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Cid André Fidelis de Paula Gomes
Principal Investigator
Principal Investigators
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Cid Gomes, PhD
Role: PRINCIPAL_INVESTIGATOR
Nove de Julho University
Locations
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Nove de Julho University
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Cid Gomes
Role: primary
Other Identifiers
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70408123.1.0000.5511
Identifier Type: -
Identifier Source: org_study_id