Back to resultsInvestigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain (RELEARN)
Primary Purpose
Chronic Knee Pain, Chronic Pain, Osteoarthritis
Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
RELEARN Neurofeedback
Standard care control
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Knee Pain focused on measuring chronic pain, Chronic Knee Pain, Osteoarthritis, Neurofeedback, EEG, EMG, Movement evoked potentials, Neuroplasticity, Pain perception
Eligibility Criteria
Inclusion Criteria:
- Age 18-65 years old
- Knee arthrosis (Kellgren-Lawrence score of > 2)
- 24h VAS ≥ 5
Ongoing pain, lasting more than three months
Exclusion Criteria:
- 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 II and above. I.e. BMI > 34,9
Sites / Locations
- Center for Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RELEARN - Intervention
Standard care control
Arm Description
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
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
Outcomes
Primary Outcome Measures
Changes in Pain Perception
Change in the 10-point Visual Analogue Scale (VAS) over time (0 = no pain, 10 = maximum imaginable pain)
Secondary Outcome Measures
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).
Change in pain characteristics
Pain characteristics (MPQ and WOMAC)
Change in consumption of analgesics
Consumption of analgesics (MQS-III)
Evaluate the safety of the RELEARN software by assessment of adverse events and device deficiencies
Incidence of AE/ADE/SAE/SADE/DD
Full Information
NCT ID
NCT05335486
First Posted
April 4, 2022
Last Updated
February 16, 2023
Sponsor
Redo-Neurosystems
Collaborators
North Denmark Regional Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05335486
Brief Title
Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain
Acronym
RELEARN
Official Title
Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Redo-Neurosystems
Collaborators
North Denmark Regional Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Knee Pain, Chronic Pain, Osteoarthritis
Keywords
chronic pain, Chronic Knee Pain, Osteoarthritis, Neurofeedback, EEG, EMG, Movement evoked potentials, Neuroplasticity, Pain perception
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RELEARN - Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Standard care control
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
RELEARN Neurofeedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care control
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in Pain Perception
Description
Change in the 10-point Visual Analogue Scale (VAS) over time (0 = no pain, 10 = maximum imaginable pain)
Time Frame
Up to 6 month
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
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
Title
Change in pain characteristics
Description
Pain characteristics (MPQ and WOMAC)
Time Frame
Up to 6 month
Title
Change in consumption of analgesics
Description
Consumption of analgesics (MQS-III)
Time Frame
Up to 6 month
Title
Evaluate the safety of the RELEARN software by assessment of adverse events and device deficiencies
Description
Incidence of AE/ADE/SAE/SADE/DD
Time Frame
Up to 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morten Kirkegaard, MSc
Phone
+4520468932
Email
mk@redoneurosystems.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Christian Leutscher, Dr. PhD
Organizational Affiliation
Center of Clinical Research, Regional Hospital North Jutland, Hjørring, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Clinical Research
City
Hjørring
ZIP/Postal Code
9800
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lillian S Søndergaard Lundberg, Registered Nurse
Phone
21849822
Email
lisks@rn.dk
First Name & Middle Initial & Last Name & Degree
Peter C Leutscher, MD, ph.d
12. IPD Sharing Statement
Plan to Share IPD
No
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Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain
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