- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03863847
A Neurofeedback Treatment for Chronic Musculoskeletal Pain
March 3, 2019 updated by: Natalie Mrachacz-Kersting, Aalborg University
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Natalie Mrachacz Kersting, Dr
- Phone Number: +4599407571
- Email: nm@hst.aau.dk
Study Contact Backup
- Name: Morten Kirkegaard, BsC
- Phone Number: +4620468932
- Email: mkirk14@student.aau.dk
Study Locations
-
-
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Aalborg, Denmark, 9000
- Recruiting
- Center For Sensory-Motor Interaction
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
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The patients will receive neurofeedback on pain related brain-activity, and through training, learn to control said brain-activity.
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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.
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The patients will receive sham neurofeedback on non-pain related brain-activity, and through training, learn to control said brain-activity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
Time Frame: Up to three months
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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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Up to three months
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Electromyographic (EMG) measurement.
Time Frame: Up to three months
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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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Up to three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Natalie Mrachacz Kersting, Dr, Aalborg University, Department of Health Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Anticipated)
December 31, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
January 2, 2019
First Submitted That Met QC Criteria
March 3, 2019
First Posted (Actual)
March 5, 2019
Study Record Updates
Last Update Posted (Actual)
March 5, 2019
Last Update Submitted That Met QC Criteria
March 3, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-20140041
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Currently this study is under IP at Aalborg University and thus data cannot be shared at this point.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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