A Neurofeedback Treatment for Chronic Musculoskeletal Pain

NCT ID: NCT03863847

Last Updated: 2019-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-12-31

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.

Conditions

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Chronic Musculoskeletal Pain Tennis Elbow Musculoskeletal Pain Lateral Epicondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Neurofeedback

Intervention Type PROCEDURE

The patients will receive neurofeedback on pain related brain-activity, and through training, learn to control said brain-activity.

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.

Group Type SHAM_COMPARATOR

Sham

Intervention Type PROCEDURE

The patients will receive sham neurofeedback on non-pain related brain-activity, and through training, learn to control said brain-activity.

Interventions

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Neurofeedback

The patients will receive neurofeedback on pain related brain-activity, and through training, learn to control said brain-activity.

Intervention Type PROCEDURE

Sham

The patients will receive sham neurofeedback on non-pain related brain-activity, and through training, learn to control said brain-activity.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Natalie Mrachacz-Kersting

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Natalie Mrachacz Kersting, Dr

Role: STUDY_DIRECTOR

Aalborg University, Department of Health Science and Technology

Locations

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Center For Sensory-Motor Interaction

Aalborg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Natalie Mrachacz Kersting, Dr

Role: CONTACT

+4599407571

Morten Kirkegaard, BsC

Role: CONTACT

+4620468932

Other Identifiers

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N-20140041

Identifier Type: -

Identifier Source: org_study_id

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