Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

Redo-Neurosystems

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Chronic Knee Pain; Osteoarthritis; Chronic Pain

Treatments: Device: RELEARN Neurofeedback; Other: Standard care control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05335486

RELEARN2200701

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

RELEARN - Intervention

Experimental group

Description:

Intervention group participants will be seen at the orthopedic ward and receive standard care for knee osteoarthrosis, defined by Danish clinical guidelines. In addition, intervention group participants will be asked to attend eight sessions of RELEARN neurofeedback with an approximate duration of 45 minutes per session. Also, participants will undergo three follow-up sessions: one month, three months, and five months post-intervention

Treatment:

Device: RELEARN Neurofeedback

Standard care control

Active Comparator group

Description:

Standard Care control. Control group participants will be seen at the orthopedic ward and receive standard care for knee osteoarthrosis, defined by Danish clinical guidelines. During standard care, the control group participants will be asked to attend eight control sessions with no RELEARN intervention with an approximate duration of 5 minutes per session. Also, participants will undergo three follow-up sessions: one month, three months, and five months post-intervention

Treatment:

Other: Standard care control