CLINICAL TRIAL

Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

 

Research

REDO – Neurosystems in collaboration with Centre of Clinical Research at the Regional hospital Hjørring, are looking for participants suffering from severe knee osteoarthritis pain for an investigation of how self-taught manipulation of pain related brain activity may affect the experience of pain.

This manipulation will be attempted through neurofeedback, which is a method which does not involve medication or surgery, where the pain patients may learn to control their brain activity by means of immediate visualization of the brain signals from the participant.

If you are interested, please do not hesitate to contact the responsible researcher:

Peter Christian Leutscher

Dr. med, PhD.,
Director, Center of Clinical Research

Professor of Clinical Medicine at Aalborg and Aarhus University

Regional Hospital, Hjørring
Bispensgade 37
9800 Hjørring

Phone: +45 6065 3960 / +45 2184 9822

Email: RELEARN@rn.dk

The trial

You are invited to participate in either 11 experimental sessions or 11 control sessions, subdivided into eight training sessions and three follow-up sessions at one, three and five months after the experiment. Each experimental session will last approximately 45 minutes.
During the experiment, you are to sit quietly and relax, whereafter you are to perform movements with the joint in which you have pain, during which we will measure electric signals from your brain and your muscles. During the experiments, we will give you feedback on your brain activity on a computer screen and ask you to attempt to change your brain activity. During the control experiment, you will not receive any treatment and will be followed to track pain progression.


All participants will also be asked to score the intensity of the pain on a scale from 0 to 10 and answer questionnaires relating to your experience of pain and how this affects your quality of life, amongst others.


You will not receive compensation for your participation.

Requirements

You can participate in the experiement if you are:

1. Age 18-65 years old

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

3. 24h VAS ≥ 4

4. Persistent pain that lasts more than three months

Exclusion criteria

Participants who meet one of the criteria below will be excluded from the study:

5. Pregnant or lactating women

6. Use of opioids or cannabis

7. Active substance abuse defined as use of cannabis, opioids or other drugs

8. Past or present neurological, 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 persistent pain such as root impaction, trauma or congenital malformation

12. Active inflammation in the area of interest

13. Blindness or deafness

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

15. Recent history of fracture 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. Severe overweight class III and above. i.e. BMI > 39.9