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A Neurofeedback Treatment for Chronic Musculoskeletal Pain

Primary Purpose

Chronic Musculoskeletal Pain, Tennis Elbow, Musculoskeletal Pain

Status

Unknown status

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Neurofeedback

Sham

About this trial

This is an interventional treatment trial for Chronic Musculoskeletal Pain focused on measuring Pain, Chronic Pain, Musculoskeletal Pain, Treatment, Neurofeedback, Brain Activity, Brain Oscillation, Brain Computer Interface

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center For Sensory-Motor InteractionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Online Neurofeedback

Online Sham Neurofeedback

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Electromyographic (EMG) measurement.

EMG electrodes will be applied to the Extensor Carpi Radials Brevis (ECRB) muscle, to provide movement temporal features for EEG extraction.

Full Information

NCT ID

NCT03863847

First Posted

January 2, 2019

Last Updated

March 3, 2019

Sponsor

Aalborg University

1. Study Identification

Unique Protocol Identification Number

NCT03863847

Brief Title

A Neurofeedback Treatment for Chronic Musculoskeletal Pain

Official Title

A Neurofeedback Treatment for Chronic Musculoskeletal Pain

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Pain, Chronic Pain, Musculoskeletal Pain, Treatment, Neurofeedback, Brain Activity, Brain Oscillation, Brain Computer Interface

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Online Neurofeedback

Arm Type

Active Comparator

Arm Description

Arm Title

Online Sham Neurofeedback

Arm Type

Sham Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Neurofeedback

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Sham

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual Analogue Scale (VAS)

Description

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)

Time Frame

Up to three months

Secondary Outcome Measure Information:

Title

Electroencephalographic (EEG) measurement. International 10-20 electrode placement with 10 channels placed on the contralateral hemisphere to the dominant limb being tested.

Description

Time Frame

Up to three months

Title

Electromyographic (EMG) measurement.

Description

EMG electrodes will be applied to the Extensor Carpi Radials Brevis (ECRB) muscle, to provide movement temporal features for EEG extraction.

Time Frame

Up to three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Natalie Mrachacz Kersting, Dr

Phone

+4599407571

nm@hst.aau.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Morten Kirkegaard, BsC

Phone

+4620468932

mkirk14@student.aau.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Natalie Mrachacz Kersting, Dr

Organizational Affiliation

Aalborg University, Department of Health Science and Technology

Official's Role

Study Director

Facility Information:

Facility Name

Center For Sensory-Motor Interaction

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Currently this study is under IP at Aalborg University and thus data cannot be shared at this point.

Learn more about this trial

A Neurofeedback Treatment for Chronic Musculoskeletal Pain

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