Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

This clinical investigation will be carried out as a randomized controlled trial conducted at the Northern Regional Hospital, Hjørring. This investigation will enrol 36 patients suffering from severe knee osteoarthritis pain, primarily from the orthopaedic ward at Hjørring Hospital, where potential participants will be identified during routine consultations.

The RELEARN intervention consists of encephalography (EEG) neurofeedback of cerebral movement evoked signatures of pain, where the participants will be instructed in attempting to manipulate these signatures to reduce pain perception. This investigation is carried out to analyse the clinical performance and safety of the RELEARN neurofeedback software.

The participants will be randomized into treatment group A and control group B, 1:1 and be stratified based on age, sex, and ethnicity. Group A participants will be asked to attend eight sessions of RELEARN neurofeedback with an approximate duration of 45 minutes per session, and group B participants will be asked to attend eight sessions with no intervention and serve as no-treatment controls with an approximate duration of 5 minutes per session. Both groups (A and B) will undergo three follow-up sessions: one month, three months, and five months post intervention.

Inclusion Criteria:

1. Age 18-65 years old

2. Knee arthrosis (Kellgren-Lawrence score of ≥ 2)

3. 24h VAS ≥ 4

4. Ongoing pain, lasting more than three months

   Exclusion Criteria:

   Participants who meet any of the below criteria will be excluded from the investigation:

5. Pregnant or lactating woman

6. Use of opioids or cannabis

7. Active drug addiction defined as the use of cannabis, opioids, or other drugs

8. Previous or current neurologic, systemic, or mental illness, including any liver, kidney or metabolic disease.

9. Rheumatoid arthritis

10. Evidence of other pain types such as visceral, neuropathic, or malignant pain.

11. Evidence of other sources of ongoing pain such as root affect, traumas, or congenital malformation

12. Severe inflammation in the area of interest

13. Blindness or deafness

14. Consumption of alcohol, caffeine, nicotine on test day

15. Recent history of fractures or surgery in the area of interest

16. Participation in other clinical trials throughout the study period and one month prior to participation

17. History of epilepsy

18. Obesity class III and above. I.e. BMI > 39,9