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

Universidad Santo Tomas, Chile

Status: Not yet enrolling

Conditions: Knee Osteoarthritis

Treatments: Other: Neuromuscular exercise; Other: Neuromuscular exercise plus pain neuroscience education

Study type: Interventional

Funder types: Other

Identifiers

NCT06482970

23-02

Details and patient eligibility

About

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.

Enrollment: 57 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 3 patient groups

Neuromuscular exercise plus Pain neuroscience education

Experimental group

Description:

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).

Treatment:

Other: Neuromuscular exercise plus pain neuroscience education

Neuromuscular exercise

Experimental group

Description:

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

Treatment:

Other: Neuromuscular exercise

Usual care

No Intervention group

Description:

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.