Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

Conditions
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Chronic Knee Pain, Chronic Pain, Osteoarthritis

Intervention / Treatment
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* Device: RELEARN Neurofeedback
* Other: Standard care control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years old Knee arthrosis (Kellgren-Lawrence score of ≥ 2) 24h VAS ≥ 4 Ongoing pain, lasting more than three months Exclusion Criteria: Participants who meet any of the below criteria will be excluded from the investigation: Pregnant or lactating woman Use of opioids or cannabis Active drug addiction defined as the use of cannabis, opioids, or other drugs Previous or current neurologic, systemic, or mental illness, including any liver, kidney or metabolic disease. Rheumatoid arthritis Evidence of other pain types such as visceral, neuropathic, or malignant pain. Evidence of other sources of ongoing pain such as root affect, traumas, or congenital malformation Severe inflammation in the area of interest Blindness or deafness Consumption of alcohol, caffeine, nicotine on test day Recent history of fractures or surgery in the area of interest Participation in other clinical trials throughout the study period and one month prior to participation History of epilepsy Obesity class III and above. I.e. BMI > 39,9

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RELEARN - Intervention<br>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 | Device: RELEARN Neurofeedback<br>* 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.<br>|
| Active Comparator: Standard care control<br>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 | Other: Standard care control<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Pain Perception | Change in the 10-point Visual Analogue Scale (VAS) over time (0 = no pain, 10 = maximum imaginable pain) | Up to 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | 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). | Up to 6 month | 
| Change in pain characteristics | Pain characteristics (MPQ and WOMAC) | Up to 6 month | 
| Change in consumption of analgesics | Consumption of analgesics (MQS-III) | Up to 6 month | 
| Evaluate the safety of the RELEARN software by assessment of adverse events and device deficiencies | Incidence of AE/ADE/SAE/SADE/DD | Up to 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, Chronic Knee Pain, Osteoarthritis, Neurofeedback, EEG, EMG, Movement evoked potentials, Neuroplasticity, Pain perception