Clinical trial NCT05335486: Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain
Official title: Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Chronic Knee Pain
Chronic Pain
Osteoarthritis
Keywords: chronic pain
Chronic Knee Pain
Osteoarthritis
Neurofeedback
EEG
EMG
Movement evoked potentials
Neuroplasticity
Pain perception
Lead sponsor: Redo-Neurosystems
Sponsor class: INDUSTRY
Collaborators: name: Regionshospital Nordjylland
First posted: 2022-04-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled study
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Changes in Pain Perception
timeFrame: Up to 6 month
Secondary outcomes:
measure: Change in quality of life
timeFrame: Up to 6 month
measure: Change in pain characteristics
timeFrame: Up to 6 month
measure: Change in consumption of analgesics
timeFrame: Up to 6 month
measure: Evaluate the safety of the RELEARN software by assessment of adverse events and device deficiencies
timeFrame: Up to 6 month
Other outcomes:
Locations:
city: Hjørring
country: Denmark
facility: Center for Clinical Research
Study officials:
affiliation: Center of Clinical Research, Regional Hospital North Jutland, Hjørring, Denmark
name: Peter Christian Leutscher, Dr. PhD
role: PRINCIPAL_INVESTIGATOR
References: