Knee OsteoarthritisNCT06482970
Effectiveness of Exercise Plus Pain Neuroscience Education on Brain Function in Knee Osteoarthritis
A study testing Neuromuscular exercise plus pain neuroscience education and Neuromuscular exercise in people with Knee Osteoarthritis, run by Universidad Santo Tomas, Chile.
Trial summary
A three-arm randomized controlled trial will be conducted. Fifty-nine participants with KOA will be recruited in a 1:1:1 ratio. Assessor, and statistician will be blinded to group allocation. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Neuromuscular exercise plus pain neuroscience education and Neuromuscular exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women and men at least 45 years old radiologically diagnosed with unilateral or bilateral KOA (Kellgren-Lawrence 1-3 grading scale)
- pain duration greater than three months
Who cannot join
- Patients who have received physical therapy or other conservative therapy in the previous three months and those who have a history of major knee trauma and surgery in the last six months
- cardiac pathology
- structural use of psychoactive medications, such as antipsychotics, antidepressants, antiepileptics, and anxiolytics, during the past year
- neurological diseases
- other musculoskeletal clinical conditions that generate pain
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Brain Function, Clinical and Psychosocial Outcomes After Neuromuscular Exercise Plus Pain Neuroscience Education Intervention in Patients With Chronic Pain Due to Knee Osteoarthritis. A Randomized Controlled Trial Protocol
A three-arm randomized controlled trial will be conducted. Fifty-nine participants with KOA will be recruited in a 1:1:1 ratio. Assessor, and statistician will be blinded to group allocation. One experimental group (n=19) will receive NME plus PNE, the other experimental group (n=19) will receive isolated NME and the control group (n=19) will continue with usual care. The PNE will be adapted to the context of the participants. Outcome measures will be brain activity, pressure pain threshold, pain intensity, disability, fear-avoidance beliefs, self-efficacy, and pain catastrophizing. Outcome measures will be evaluated pre-intervention, immediately post-intervention, and four-month post-intervention.
The investigators hypothesize that there will be significant differences in favor of the NME plus PNE intervention group.
- Conditions
- Knee Osteoarthritis
- Being tested
- Neuromuscular exercise plus pain neuroscience education, Neuromuscular exercise
- Keywords
- Neuromuscular exercise, Pain neuroscience education, Knee osteoarthritis, Chronic pain, Physical therapy
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular exercise plus pain neuroscience educationOther
The exercises follow neuromuscular principles, which aim to improve sensorimotor control and achieve compensatory functional stability (also called dynamic stability).
Pain neuroscience education will take an active, person-centered approach through their own fear-avoidance beliefs.
Neuromuscular exerciseOther
The exercises follow neuromuscular principles, which aim to improve sensorimotor control and achieve compensatory functional stability (also called dynamic stability).
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular exercise plus Pain neuroscience education | Experimental | Neuromuscular exercise will be carried out for eight weeks, with three weekly sessions, in groups (up to five participants per group).
Each session will consist of three parts: warm-up, exercise circuit and cool down. Each part will be regulated for the abilities of the participants
Pain neuroscience education will be carried in group using visual support for Powerpoint presentations. The PNE will include five dimensions with a focus on reducing fear-avoidance beliefs and catastrophic thoughts to promote self-efficacy. Five PNE sessions will be carried out, one for each dimension, with a duration of 30-45 minutes each taught during the first five sessions of the intervention. In addition, a brochure will be delivered with the main points of each of the domains and an informative video will be made to which participants will have access (five 15-minute videos, one per domain). Receives: Other: Neuromuscular exercise plus pain neuroscience education |
| Neuromuscular exercise | Experimental | Neuromuscular exercise will be carried out for eight weeks, with three weekly sessions, in groups (up to five participants per group).
Each session will consist of three parts: warm-up, exercise circuit and cool down. Each part will be regulated for the abilities of the participants Receives: Other: Neuromuscular exercise |
| Usual care | No intervention | Participants will be urged to continue with their life activities without changes. All participants will continue to receive routine care offered by their doctor and other health care providers. No trial interventions were provided. The possible treatments that may be provided to the participants in this group (if the primary medical team deems it appropriate) will not be influenced. However, if the participants receive any treatment from their medical staff, it will be recorded as an extra history and the participant will not be considered in the analyses. All participants in this group will be eligible to receive the experimental therapies of their choice once the study is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain function (peak frequency)
An analysis of the peak frequencies (the highest power frequency determined in the average of the windows as the local maximum (greater than its two neighboring windows) of the amplitude in a frequency range of 6-14 Hz will be applied.
Measured: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Brain function (power spectrum)
A global analysis of the power spectrum will be carried out, considered as the average of all the electrodes, which represents the synchronization between the neurons to generate the discharges. A topographic power analysis will also be performed for the Delta (0.1 - 4 Hz), theta (4 - 8 Hz), alpha (8 - 13 Hz) and beta (13 - 30 Hz) frequency bands.
Measured: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Secondary outcomes (6)
Pain pressure-threshold
A digital algometer (WAGNER FDX10) will be used to measure pressure pain sensitivity. The average of three measurements will be used. Patients will be evaluated lying supine in a comfortable position according to the area to be evaluated. It will be performed at two test sites on the affected knee(s) (3 cm medial and lateral to the midpoint of the medial and lateral edge of the patella, respectively) and will also be applied to a distant site on the ipsilateral carpal extensor radialis longus (5 cm distal to the lateral epicondyle).
Measured: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Pain intensity
The pain intensity will be measured with the Visual Analogue Scale (VAS), which consists of a 10 cm straight line with two labels, at one end "no pain" and at the other "the worst possible pain" where the patient will draw a vertical mark indicating your pain level. The pain intensity at rest and during activity in the last 7 days will be considered.
Measured: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Disability
Disability will be assessed with the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) questionnaire. It consists of 24 questions divided into 3 domains: pain, stiffness and physical function with 5, 2 and 17 questions, respectively. Each question is scored on a Likert scale of 0-4, corresponding to the intensity levels of none, slight, moderate, severe and extreme pain. A higher WOMAC score indicates worse health status.
Measured: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Fear-avoidance beliefs
Fear-avoidance beliefswill be evaluated with the Fear Avoidance Beliefs Questionnaire (FABQ). This questionnaire consists of 2 subscales with 16 items in total 70. It is rated on a 7-point Likert scale (0=strongly disagree to 6=strongly agree).
Measured: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Self-efficacy
Self-efficacy will be evaluated with the Pain Self-Efficacy Questionnaire (PSEQ) will be used. It consists of 10 items rated on a 7-point Likert scale from 0 ("not at all confident") to 6 ("very confident")
Measured: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Pain Catastrophizing
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS) questionnaire. It consists of 3 subscales (rumination, magnification and helplessness) with 13 questions in total, which are scored on a Likert scale from 0 (mild symptoms) to 4 (worst symptoms) points. The higher the score, the more pain catastrophizing the patient presents.
Measured: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start15 Mar 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Santo Tomas, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquín Ignacio Salazar Méndez, Universidad Santo Tomas, Chile
- Investigators
- Joaquín I Salazar, MSc, Principal investigator, Universidad Santo Tomás
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482970
- Sponsor's protocol ID
- 23-02
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Function, Clinical and Psychosocial Outcomes After Neuromuscular Exercise Plus Pain Neuroscience Education Intervention in Patients With Chronic Pain Due to Knee Osteoarthritis. A Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT06482970
- Acronym / sponsor ID
- 23-02
- Conditions
- Knee Osteoarthritis
- Keywords
- Neuromuscular exercise, Pain neuroscience education, Knee osteoarthritis, Chronic pain, Physical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Universidad Santo Tomas, ChileUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 1 Jul 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.
A three-arm randomized controlled trial will be conducted. Fifty-nine participants with KOA will be recruited in a 1:1:1 ratio. Assessor, and statistician will be blinded to group allocation. One experimental group (n=19) will receive NME plus PNE, the other experimental group (n=19) will receive isolated NME and the control group (n=19) will continue with usual care. The PNE will be adapted to the context of the participants. Outcome measures will be brain activity, pressure pain threshold, pain intensity, disability, fear-avoidance beliefs, self-efficacy, and pain catastrophizing. Outcome measures will be evaluated pre-intervention, immediately post-intervention, and four-month post-intervention.
The investigators hypothesize that there will be significant differences in favor of the NME plus PNE intervention group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular exercise plus Pain neuroscience education | Experimental | Other: Neuromuscular exercise plus pain neuroscience educationNeuromuscular exercise will be carried out for eight weeks, with three weekly sessions, in groups (up to five participants per group). Each session will consist of three parts: warm-up, exercise circuit and cool down. Each part will be regulated for the abilities of the participants Pain neuroscience education will be carried in group using visual support for Powerpoint presentations. The PNE will include five dimensions with a focus on reducing fear-avoidance beliefs and catastrophic thoughts to promote self-efficacy. Five PNE sessions will be carried out, one for each dimension, with a duration of 30-45 minutes each taught during the first five sessions of the intervention. In addition, a brochure will be delivered with the main points of each of the domains and an informative video will be made to which participants will have access (five 15-minute videos, one per domain). |
| Neuromuscular exercise | Experimental | Other: Neuromuscular exerciseNeuromuscular exercise will be carried out for eight weeks, with three weekly sessions, in groups (up to five participants per group). Each session will consist of three parts: warm-up, exercise circuit and cool down. Each part will be regulated for the abilities of the participants |
| Usual care | No intervention | –Participants will be urged to continue with their life activities without changes. All participants will continue to receive routine care offered by their doctor and other health care providers. No trial interventions were provided. The possible treatments that may be provided to the participants in this group (if the primary medical team deems it appropriate) will not be influenced. However, if the participants receive any treatment from their medical staff, it will be recorded as an extra history and the participant will not be considered in the analyses. All participants in this group will be eligible to receive the experimental therapies of their choice once the study is completed. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women and men at least 45 years old radiologically diagnosed with unilateral or bilateral KOA (Kellgren-Lawrence 1-3 grading scale)
- pain duration greater than three months
Key exclusion criteria (5 listed)
- Patients who have received physical therapy or other conservative therapy in the previous three months and those who have a history of major knee trauma and surgery in the last six months
- cardiac pathology
- structural use of psychoactive medications, such as antipsychotics, antidepressants, antiepileptics, and anxiolytics, during the past year
- neurological diseases
- other musculoskeletal clinical conditions that generate pain
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 |
|---|---|---|
| Neuromuscular exercise plus pain neuroscience educationThe exercises follow neuromuscular principles, which aim to improve sensorimotor control and achieve compensatory functional stability (also called dynamic stability). Pain neuroscience education will take an active, person-centered approach through their own fear-avoidance beliefs. | Other | Neuromuscular exercise plus Pain neuroscience education |
| Neuromuscular exerciseThe exercises follow neuromuscular principles, which aim to improve sensorimotor control and achieve compensatory functional stability (also called dynamic stability). | Other | Neuromuscular exercise |
Primary outcome
Brain function (peak frequency)
Time frame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
An analysis of the peak frequencies (the highest power frequency determined in the average of the windows as the local maximum (greater than its two neighboring windows) of the amplitude in a frequency range of 6-14 Hz will be applied.
Brain function (power spectrum)
Time frame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
A global analysis of the power spectrum will be carried out, considered as the average of all the electrodes, which represents the synchronization between the neurons to generate the discharges. A topographic power analysis will also be performed for the Delta (0.1 - 4 Hz), theta (4 - 8 Hz), alpha (8 - 13 Hz) and beta (13 - 30 Hz) frequency bands.
6 secondary outcomes
Pain pressure-threshold
Time frame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Pain intensity
Time frame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Disability
Time frame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Fear-avoidance beliefs
Time frame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Self-efficacy
Time frame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Pain Catastrophizing
Time frame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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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. This study is not recruiting at the moment.
Joaquín I Salazar, MSc principal investigator
Universidad Santo Tomás
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular exercise plus pain neuroscience education and Neuromuscular exercise in people with Knee Osteoarthritis, run by Universidad Santo Tomas, Chile.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joaquín I Salazar, MSc (+569 73785287, jsalazar13@santotomas.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain function (peak frequency) (time frame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.). The study lists 2 primary outcomes in all. 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 1 Jul 2024.