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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
Sponsor:
Information provided by (Responsible Party):
Natalie Mrachacz-Kersting, Aalborg University

Brief Summary:

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

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Procedure: Neurofeedback
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.
Procedure: Sham
The patients will receive sham neurofeedback on non-pain related brain-activity, and through training, learn to control said brain-activity.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Natalie Mrachacz Kersting, Dr +4599407571 nm@hst.aau.dk
Contact: Morten Kirkegaard, BsC +4620468932 mkirk14@student.aau.dk

Locations
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Denmark
Center For Sensory-Motor Interaction Recruiting
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg University
Investigators
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Study Director: Natalie Mrachacz Kersting, Dr Aalborg University, Department of Health Science and Technology

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Responsible Party: Natalie Mrachacz-Kersting, Associate Professor, Aalborg University
ClinicalTrials.gov Identifier: NCT03863847     History of Changes
Other Study ID Numbers: N-20140041
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently this study is under IP at Aalborg University and thus data cannot be shared at this point.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Natalie Mrachacz-Kersting, Aalborg University:
Pain
Chronic Pain
Musculoskeletal Pain
Treatment
Neurofeedback
Brain Activity
Brain Oscillation
Brain Computer Interface

Additional relevant MeSH terms:
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Musculoskeletal Pain
Tennis Elbow
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Elbow Tendinopathy
Tendinopathy
Arm Injuries
Wounds and Injuries
Tendon Injuries