Effectiveness of Exercise Plus Pain Neuroscience Education on Brain Function in Knee Osteoarthritis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Neuromuscular exercise plus pain neuroscience education; Other: Neuromuscular exercise

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joaquín I Salazar, MSc; Phone Number: +569 73785287; Email: jsalazar13@santotomas.cl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuromuscular exercise plus Pain neuroscience education; 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).	Other: Neuromuscular exercise plus pain neuroscience education; 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.
Experimental: Neuromuscular exercise; 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	Other: Neuromuscular exercise; The exercises follow neuromuscular principles, which aim to improve sensorimotor control and achieve compensatory functional stability (also called dynamic stability).
No Intervention: Usual care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Universidad Santo Tomas, Chile
• Investigators: Principal Investigator: Joaquín I Salazar, MSc, Universidad Santo Tomás

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2025
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Chronic pain; Knee osteoarthritis; Physical therapy; Pain neuroscience education; Neuromuscular exercise
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 23-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD, all IPD that underlie results in a publication
• IPD Sharing Time Frame: from 6 months after publication. They will be available for one year
• IPD Sharing Access Criteria: will be provided to any researcher who requires it via email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No