A Neurofeedback Treatment for Chronic Musculoskeletal Pain
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|ClinicalTrials.gov Identifier: NCT03863847|
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Musculoskeletal Pain Tennis Elbow Musculoskeletal Pain Lateral Epicondylitis||Procedure: Neurofeedback Procedure: Sham||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Neurofeedback Treatment for Chronic Musculoskeletal Pain|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Active Comparator: Online Neurofeedback
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.
The patients will receive neurofeedback on pain related brain-activity, and through training, learn to control said brain-activity.
Sham Comparator: Online Sham Neurofeedback
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.
The patients will receive sham neurofeedback on non-pain related brain-activity, and through training, learn to control said brain-activity.
- Visual Analogue Scale (VAS) [ Time Frame: Up to three months ]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)
- Electroencephalographic (EEG) measurement. International 10-20 electrode placement with 10 channels placed on the contralateral hemisphere to the dominant limb being tested. [ Time Frame: Up to three months ]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.
- Electromyographic (EMG) measurement. [ Time Frame: Up to three months ]EMG electrodes will be applied to the Extensor Carpi Radials Brevis (ECRB) muscle, to provide movement temporal features for EEG extraction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863847
|Contact: Natalie Mrachacz Kersting, Dremail@example.com|
|Contact: Morten Kirkegaard, BsCfirstname.lastname@example.org|
|Center For Sensory-Motor Interaction||Recruiting|
|Aalborg, Denmark, 9000|
|Study Director:||Natalie Mrachacz Kersting, Dr||Aalborg University, Department of Health Science and Technology|