Status:
WITHDRAWN
Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain
Lead Sponsor:
Redo-Neurosystems
Collaborating Sponsors:
Regionshospital Nordjylland
Conditions:
Chronic Knee Pain
Chronic Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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 ...
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 R...
Eligibility Criteria
Inclusion
- Age 18-65 years old
- Knee arthrosis (Kellgren-Lawrence score of ≥ 2)
- 24h VAS ≥ 4
- Ongoing pain, lasting more than three months
Exclusion
- 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
Key Trial Info
Start Date :
October 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05335486
Start Date
October 5 2022
End Date
July 1 2023
Last Update
February 6 2024
Active Locations (1)
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1
Center for Clinical Research
Hjørring, Denmark, 9800