A Neurofeedback Treatment for Chronic Musculoskeletal Pain

Not Applicable

• Conditions: Tennis Elbow; Musculoskeletal Pain; Lateral Epicondylitis; Chronic Musculoskeletal Pain
• Interventions: Procedure: Neurofeedback; Procedure: Sham

• Registration Number: NCT03863847
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-01-02
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-03
• Last Update Submitted: 2019-03-03
• Study First Posted: 2019-03-05
• Last Update Posted: 2019-03-05
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online Neurofeedback	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.
Online Sham Neurofeedback	Sham	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	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

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

Trial Locations

Locations (1)

Center For Sensory-Motor Interaction; 🇩🇰 Aalborg, Denmark