A Phase 2/3 interventional study of RELEARN Neurofeedback and Standard care control in Chronic Knee Pain, Chronic Pain and Osteoarthritis, sponsored by Redo-Neurosystems. Withdrawn at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by Redo-Neurosystems · Phase 2/3, Interventional, and Treatment
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
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Exclusion Criteria:
Participants who meet any of the below criteria will be excluded from the investigation:
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
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
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
Changes in Pain Perception
Change in the 10-point Visual Analogue Scale (VAS) over time (0 = no pain, 10 = maximum imaginable pain)
Time frame: Up to 6 month
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).
Time frame: Up to 6 month
Change in pain characteristics
Pain characteristics (MPQ and WOMAC)
Time frame: Up to 6 month
Change in consumption of analgesics
Consumption of analgesics (MQS-III)
Time frame: 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
Time frame: Up to 6 month
Plan to share: No
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This study is withdrawn, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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