Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-05

Study Completion Date

2023-07-01

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.

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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.

Conditions

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Chronic Knee Pain Chronic Pain Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RELEARN - Intervention

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

Group Type EXPERIMENTAL

RELEARN Neurofeedback

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Standard care control

Intervention Type OTHER

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

Interventions

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RELEARN Neurofeedback

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 DEVICE

Standard care control

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 OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No