Clinical trial NCT03863847: A Neurofeedback Treatment for Chronic Musculoskeletal Pain
Official title: A Neurofeedback Treatment for Chronic Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Tennis Elbow
Musculoskeletal Pain
Lateral Epicondylitis
Keywords: Pain
Chronic Pain
Musculoskeletal Pain
Treatment
Neurofeedback
Brain Activity
Brain Oscillation
Brain Computer Interface
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Up to three months
Secondary outcomes:
measure: Electroencephalographic (EEG) measurement. International 10-20 electrode placement with 10 channels placed on the contralateral hemisphere to the dominant limb being tested.
timeFrame: Up to three months
measure: Electromyographic (EMG) measurement.
timeFrame: Up to three months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Center For Sensory-Motor Interaction
Study officials:
affiliation: Aalborg University, Department of Health Science and Technology
name: Natalie Mrachacz Kersting, Dr
role: STUDY_DIRECTOR
References: