A Neurofeedback Treatment for Chronic Musculoskeletal Pain

NCT03863847 | Unknown

• 1 other identifier: N-20140041
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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)

  Up to three months

Secondary Outcomes (2)

• 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

• Electromyographic (EMG) measurement.

  Up to three months

Study Arms (2)

Online Neurofeedback

ACTIVE COMPARATOR

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.

Procedure: Neurofeedback

Online Sham Neurofeedback

SHAM COMPARATOR

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.

Procedure: Sham

Interventions

Neurofeedback PROCEDURE

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

Online Neurofeedback

Sham PROCEDURE

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

Online Sham Neurofeedback

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Center For Sensory-Motor Interaction

Aalborg, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Tennis Elbow; Musculoskeletal Pain; Pain; Chronic Pain

Interventions

Neurofeedback; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Natalie Mrachacz Kersting, Dr

  Aalborg University, Department of Health Science and Technology

  STUDY DIRECTOR

Central Study Contacts

Natalie Mrachacz Kersting, Dr

CONTACT

+4599407571; nm@hst.aau.dk

Morten Kirkegaard, BsC

CONTACT

+4620468932; mkirk14@student.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: March 5, 2019
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)