Osteoarthritis, KneeNCT06187038
Effects of Including a Chronic Pain Neuroscience Education Program for Individuals With Knee OA
A study testing Therapeutic exercises and Therapeutic exercises + pain neuroscience education program in people with Osteoarthritis, Knee, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Therapeutic exercises and Therapeutic exercises + pain neuroscience education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteBrazil
- Study dates
- 28 May 2024to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Nove de Julho University
São Paulo, 01504-001
Cid Gomes
Cid Gomes, Phd
About this study
Official title: Effects of Including a Chronic Pain Neuroscience Education Program for Individuals With Knee OA: Randomized, Blinded Clinical Trial
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
- Being tested
- Therapeutic exercises, Therapeutic exercises + pain neuroscience education program
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercisesOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Therapeutic exercises; Other: Therapeutic exercises + pain neuroscience education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
Secondary outcomes (7)
Numerical Pain Scale
The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.
Measured: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
Functional self-perception
Pain self-efficacy questionnaire, structured into 10 items where each item is evaluated by selecting a number on a 7-point numerical scale (scores from 0 to 6), where 0 means "not at all confident" and 6 means "completely confident". The items cover different functions, from work, social activities, domestic tasks and coping with pain without medication. A total score is calculated from the sum of the scores for each of the 10 items, producing a total score that ranges from 0 to 60. Higher scores reflect stronger self-efficacy beliefs.
Measured: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
Self-perceived functionality
Patient Specific Functional Scale. An easy-to-apply self-report instrument, validated for measuring disability related to specific tasks identified by the individual. The scale is made up of 11 (eleven) numbers, graduated from 0 (zero) to 10 (ten), where 0 (zero) represents inability to perform the activity and ten (ten) the ability to perform the activity at the level prior to the current condition.
Measured: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
Maximum voluntary isometric contraction
manual dynamometer portable (Lafayette Manual Muscle System, Modelo 01165, Lafayette Instrument Company, Lafayette, IN). Four 5-second readings will be taken during maximal voluntary isometric contraction (MVIC) with a 30-second rest period between contractions. The first CIVM will familiarize the volunteer with carrying out the task. A new set of readings will be taken if a volunteer can perform three contractions with at least 10% variability. Strong and constant verbal stimuli will be used throughout the test. Always with the research participants' hands positioned crossed on the chest. Thus, bilateral assessments of the muscles, quadriceps, and gluteus medius will be carried out. The order of CIVM readings will be randomized to avoid collection bias. The research participant will remain in lateral decubitus with a pillow positioned between the legs, with the limb to be tested superiorly in a neutral position.
Measured: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
Dynamic balance
Iimed up and go test, research participants will be instructed to get up from a chair, walk 3 meters comfortably and safely, come back and sit down in the chair. The time taken to complete this task will be measured using a stopwatch that will be started after the verbal command 'go' and stopped when the participant returns to the initial sitting position. A first attempt will be made to familiarize the participant with the procedure. Two assessments will then be carried out. The average of the two assessments will be recorded for later data analysis.
Measured: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
Global Perception of Change scale
The perception of the global effect of the treatment by the research participant will be evaluated by the Global Perception of Change scale. The Global Perception of Change scale is a direct scale on the patient's self-perception when the intervention is performed. This scale consists of 11 points, ranging from -5 (worsening compared to the start of treatment), 0 (neutral) and +5 (improvement compared to the start of treatment), using the Portuguese version.
Measured: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
Functionality
The WHODAS 2.0 short version (12 items) is a generic self-report assessment instrument developed by the World Health Organization (WHO) to assess functionality and disability during the last 30 days
Measured: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start28 May 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cid André Fidelis de Paula Gomes, University of Nove de Julho
- Investigators
- Cid Gomes, PhD, Principal investigator, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187038
- Sponsor's protocol ID
- 70408123.1.0000.5511
- Status last verified
- May 2026
- First submitted
- 15 Dec 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Make data available remotely in digital cloud storage.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Including a Chronic Pain Neuroscience Education Program for Individuals With Knee OA: Randomized, Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT06187038
- Acronym / sponsor ID
- 70408123.1.0000.5511
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise group | Active comparator | Other: Therapeutic exercisesThe 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 exercise group and pain neuroscience education program | Experimental | Other: Therapeutic exercises, Other: Therapeutic exercises + pain neuroscience education programThe 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- Hip OA
- severe osteoporosis
- Fibromyalgia
- Medical history of tumors or cancer
- Active inflammatory joint diseases (rheumatoid arthritis, gout)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic exercisesThe 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. | Other | Therapeutic exercise group, Therapeutic exercise group and pain neuroscience education program |
| Therapeutic exercises + pain neuroscience education programIn 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. | Other | Therapeutic exercise group and pain neuroscience education program |
Primary outcome
Functional disability
Time frame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.
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).
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided. Make data available remotely in digital cloud storage.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cid Gomes, PhD principal investigator
Nove de Julho University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercises and Therapeutic exercises + pain neuroscience education program in people with Osteoarthritis, Knee, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cid Gomes, PhD (+5511970941936, cid.andre@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional disability (time frame: Change from Baseline, after 10 weeks of intervention and 4 weeks after the end of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.