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

NCT ID: NCT06482970

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-12-30

Brief 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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Neuromuscular exercise plus pain neuroscience education

Intervention Type: OTHER

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 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

Group Type: EXPERIMENTAL

Neuromuscular exercise

Intervention Type: OTHER

The exercises follow neuromuscular principles, which aim to improve sensorimotor control and achieve compensatory functional stability (also called dynamic stability).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Neuromuscular exercise

The exercises follow neuromuscular principles, which aim to improve sensorimotor control and achieve compensatory functional stability (also called dynamic stability).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Santo Tomas, Chile

OTHER

Sponsor Role: lead

Responsible Party

Joaquín Ignacio Salazar Méndez

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joaquín I Salazar, MSc

Role: PRINCIPAL_INVESTIGATOR

Universidad Santo Tomás

Central Contacts

Joaquín I Salazar, MSc

Role: CONTACT

jsalazar13@santotomas.cl

+569 73785287

Other Identifiers

23-02

Identifier Type: -

Identifier Source: org_study_id