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This study evaluates the effects of a novel neurofeedback treatment on pain specific brainwaves in adults.
Chronic pain patients enrolled in this study will be randomized into a treatment group and a sham group.
Recent research has underlined that central nervous system structures play a key role in the development of pain with significant maladaptive plasticity occurring in several brain areas. Non-pharmacological treatments, such as neurofeedback, are designed to restore normal brain function alongside with relieving pain symptoms. With a neurofeedback approach, the patient is provided with a feedback on specific brain waves recorded using non-invasive recording techniques (electroencephalography - EEG) and visualized on a screen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online Neurofeedback | Active Comparator | This intervention entails online feedback of pain-related neuronal oscillation power, and will be visualized to the individual for patient training purposes and for the eventual self-control of this brain activity. |
|
| Online Sham Neurofeedback | Sham Comparator | This intervention entails online sham feedback of non-pain related neuronal oscillation power, and will be visualized to the individual for patient training purposes and for the eventual self-control of this brain activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurofeedback | Procedure | The patients will receive neurofeedback on pain related brain-activity, and through training, learn to control said brain-activity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | Numerical pain scale ranging from 0 being no pain to 10 being worst imaginable pain (significant change in VAS score will be set to 1 at P = 0.05) | Up to three months |
| Measure | Description | Time Frame |
|---|---|---|
| Electroencephalographic (EEG) measurement. International 10-20 electrode placement with 10 channels placed on the contralateral hemisphere to the dominant limb being tested. | Quantitative brain activity analysis to provide the subject with real-time feedback of their brain activity. The neurofeedback group will receive feedback on alpha brainwave power and learn to control this, while the sham group will receive feedback on non-pain related brain activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalie Mrachacz Kersting, Dr | Contact | +4599407571 | nm@hst.aau.dk | |
| Morten Kirkegaard, BsC | Contact | +4620468932 | mkirk14@student.aau.dk |
| Name | Affiliation | Role |
|---|---|---|
| Natalie Mrachacz Kersting, Dr | Aalborg University, Department of Health Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center For Sensory-Motor Interaction | Recruiting | Aalborg | 9000 | Denmark |
Currently this study is under IP at Aalborg University and thus data cannot be shared at this point.
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham | Procedure | The patients will receive sham neurofeedback on non-pain related brain-activity, and through training, learn to control said brain-activity. |
|
| Up to three months |
| Electromyographic (EMG) measurement. | EMG electrodes will be applied to the Extensor Carpi Radials Brevis (ECRB) muscle, to provide movement temporal features for EEG extraction. | Up to three months |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |