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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 57
- Primary Endpoint
- Brain function (peak frequency)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Brain function (peak frequency)
Time Frame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
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.
Brain function (power spectrum)
Time Frame: baseline, post-intervention (2 months after admission), follow-up four months after the intervention.
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.
Secondary Outcomes
- Pain pressure-threshold(baseline, post-intervention (2 months after admission), follow-up four months after the intervention.)
- Disability(baseline, post-intervention (2 months after admission), follow-up four months after the intervention.)
- Fear-avoidance beliefs(baseline, post-intervention (2 months after admission), follow-up four months after the intervention.)
- Pain intensity(baseline, post-intervention (2 months after admission), follow-up four months after the intervention.)
- Self-efficacy(baseline, post-intervention (2 months after admission), follow-up four months after the intervention.)
- Pain Catastrophizing(baseline, post-intervention (2 months after admission), follow-up four months after the intervention.)
Investigators
Joaquín Ignacio Salazar Méndez
principal investigator
Universidad Santo Tomas, Chile