Chronic Knee Pain, Chronic Pain, Osteoarthritis
Conditions
Keywords
chronic pain, Chronic Knee Pain, Osteoarthritis, Neurofeedback, EEG, EMG, Movement evoked potentials, Neuroplasticity, Pain perception
Brief summary
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.
Detailed 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.
Interventions
DEVICERELEARN Neurofeedback
Standard care + The RELEARN intervention. Intervention group participants will be seen at the orthopedic ward and receive standard care for knee osteoarthrosis, defined by Danish clinical guidelines. During standard care, intervention group participants will be subject to the RELEARN intervention, consisting 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.
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
Sponsors
Regionshospital Nordjylland
Redo-Neurosystems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Pain Perception | Up to 6 month | Change in the 10-point Visual Analogue Scale (VAS) over time (0 = no pain, 10 = maximum imaginable pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | Up to 6 month | QoL (EQ-5D), Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). |
| Change in pain characteristics | Up to 6 month | Pain characteristics (MPQ and WOMAC) |
| Change in consumption of analgesics | Up to 6 month | Consumption of analgesics (MQS-III) |
| Evaluate the safety of the RELEARN software by assessment of adverse events and device deficiencies | Up to 6 month | Incidence of AE/ADE/SAE/SADE/DD |
Countries
Denmark
Outcome results
None listed