A Neurofeedback Treatment for Chronic Musculoskeletal Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Neurofeedback Treatment for Chronic Musculoskeletal Pain

Conditions
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Chronic Musculoskeletal Pain, Tennis Elbow, Musculoskeletal Pain, Lateral Epicondylitis

Intervention / Treatment
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* Procedure: Neurofeedback
* Procedure: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from chronic pain due to tennis elbow for at least 3 months A clinical diagnosis of chronic lateral epicondylalgia, Pain associated with functional activities such as gripping and pain with resisted contraction of the wrist extensors or extensor carpi radialis brevis, or with passive stretching of the wrist extensors. Exclusion Criteria: Clinical diagnosis of chronic lateral epicondylalgia on both sides, cervicothoracic spinal pathology, other upper limb musculoskeletal disorders or neurological disorders Pregnancy Drug addiction defined as the use of cannabis, opioids or other drugs Previous or current neurologic, musculoskeletal or mental illnesses defined as an on-going systemic condition Lack of ability to cooperate Current use of medications that may affect the trial e.g. analgesics, anti- inflammatory drugs Consumption of alcohol, caffeine, nicotine or painkillers throughout the study period Past history of chronic pain, neurological or psychiatric conditions Participation in other pain trials throughout the study period and one month prior to participation Participation in more than two sessions of muscle training exercises per week involving the upper limb and/or lower back Evidence of other sources of elbow pain such as exacerbation of pain with neck movement or manual examination Sensory disturbances History of fractures Elbow surgery Contraindications to the use of TMS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Online Neurofeedback<br>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. | Procedure: Neurofeedback<br>* The patients will receive neurofeedback on pain related brain-activity, and through training, learn to control said brain-activity.<br>|
| Sham Comparator: Online Sham Neurofeedback<br>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. | Procedure: Sham<br>* The patients will receive sham neurofeedback on non-pain related brain-activity, and through training, learn to control said brain-activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Chronic Pain, Musculoskeletal Pain, Treatment, Neurofeedback, Brain Activity, Brain Oscillation, Brain Computer Interface