AzTrials
AzTrials

Chronic Knee PainPhase 2/3RELEARNNCT05335486

Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

A Phase 2/3 study testing RELEARN Neurofeedback in people with Chronic Knee Pain and Chronic Pain, run by Redo-Neurosystems at 1 site in Denmark.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Knee Pain, Chronic Pain, Osteoarthritis
What is being tested?
RELEARN Neurofeedback
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteDenmark
Study dates
5 Oct 2022to 1 Jul 2023
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65 years old
  • Knee arthrosis (Kellgren-Lawrence score of ≥ 2)
  • 24h VAS ≥ 4
  • Ongoing pain, lasting more than three months

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Center for Clinical Research

    Hjørring, 9800

Other trials in Denmark

About this study

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.

Read the 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.

Being tested
RELEARN Neurofeedback, Standard care control
Keywords
chronic pain, Chronic Knee Pain, Osteoarthritis, Neurofeedback, EEG, EMG, Movement evoked potentials, Neuroplasticity, Pain perception
Medical subject headings
Chronic Pain, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RELEARN NeurofeedbackDevice

    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 controlOther

    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

Study groups in NCT05335486
Study groupRoleWhat they receive
RELEARN - InterventionExperimentalIntervention 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
Receives: Device: RELEARN Neurofeedback
Standard care controlActive comparatorStandard 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
Receives: Other: Standard care control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Pain Perception

    Change in the 10-point Visual Analogue Scale (VAS) over time (0 = no pain, 10 = maximum imaginable pain)

    Measured: Up to 6 month

Secondary outcomes (4)

  1. 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).

    Measured: Up to 6 month

  2. Change in pain characteristics

    Pain characteristics (MPQ and WOMAC)

    Measured: Up to 6 month

  3. Change in consumption of analgesics

    Consumption of analgesics (MQS-III)

    Measured: Up to 6 month

  4. Evaluate the safety of the RELEARN software by assessment of adverse events and device deficiencies

    Incidence of AE/ADE/SAE/SADE/DD

    Measured: Up to 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2022
  2. Study start5 Oct 2022
  3. Primary completion1 Jul 2023
  4. Study completion1 Jul 2023

Why it stopped: Lack of clinician interest and insufficient patient availability

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised controlled study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05335486
Sponsor's protocol ID
RELEARN2200701
Acronym
RELEARN
Status last verified
Feb 2024
First submitted
4 Apr 2022
Last updated
6 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing RELEARN Neurofeedback in people with Chronic Knee Pain and Chronic Pain, run by Redo-Neurosystems at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Pain Perception (time frame: Up to 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05335486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in