Effectiveness of Exercise Plus Pain Neuroscience Education on Brain Function in Knee Osteoarthritis
NCT Number: NCT06482970
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Osteoarthritis
Interventions: OTHER: Neuromuscular exercise plus pain neuroscience education|OTHER: Neuromuscular exercise
Sponsor: Universidad Santo Tomas, Chile
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 57
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-03-15
Completion Date: 2025-12-30

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. 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.

Primary Outcome Measures: 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., 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., baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Secondary Outcome Measures: 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)., 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., 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., 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)., 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"), 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., baseline, post-intervention (2 months after admission), follow-up four months after the intervention.