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

NCT06187038 | Active Not Recruiting DMC

• 1 other identifier: 70408123.1.0000.5511
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Functional disability

  Knee Injury and Osteoarthritis Outcome Score (KOOS). It aims to evaluate the domains of pain, symptoms, activities of daily living, function related to recreation and sports, and quality of life related to the knee. Totaling 42 items, each item must be answered using a Likert scale that ranges from 0 (best score) to 4 (worst score), and the score for each subscale ranges from 0 (worst score) to 100 (best score).

  Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.

Secondary Outcomes (7)

• Numerical Pain Scale

  Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.

• Functional self-perception

  Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.

• Self-perceived functionality

  Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.

• Maximum voluntary isometric contraction

  Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.

• Dynamic balance

  Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.

Study Arms (2)

Therapeutic exercise group

ACTIVE COMPARATOR

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.

Other: Therapeutic exercises

Therapeutic exercise group and pain neuroscience education program

EXPERIMENTAL

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.

Other: Therapeutic exercises; Other: Therapeutic exercises + pain neuroscience education program

Interventions

Therapeutic exercises OTHER

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; Therapeutic exercise group and pain neuroscience education program

Therapeutic exercises + pain neuroscience education program OTHER

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.

Therapeutic exercise group and pain neuroscience education program

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, 01504-001, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Cid Gomes, PhD

  Nove de Julho University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 2, 2024
• Study Start: May 28, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

BR (1)