Clinical trial NCT06482970: Effectiveness of Exercise Plus Pain Neuroscience Education on Brain Function in Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Neuromuscular exercise
Pain neuroscience education
Knee osteoarthritis
Chronic pain
Physical therapy
Lead sponsor: Universidad Santo Tomas, Chile
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 57
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Brain function (peak frequency)
timeFrame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
measure: Brain function (power spectrum)
timeFrame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Secondary outcomes:
measure: Pain pressure-threshold
timeFrame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
measure: Pain intensity
timeFrame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
measure: Disability
timeFrame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
measure: Fear-avoidance beliefs
timeFrame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
measure: Self-efficacy
timeFrame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
measure: Pain Catastrophizing
timeFrame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Santo Tomás
name: Joaquín I Salazar, MSc
role: PRINCIPAL_INVESTIGATOR
References: