Chronic Musculoskeletal PainNCT03863847
A Neurofeedback Treatment for Chronic Musculoskeletal Pain
A study testing Neurofeedback in people with Chronic Musculoskeletal Pain and Tennis Elbow, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Musculoskeletal Pain, Tennis Elbow, Musculoskeletal Pain
- What is being tested?
- Neurofeedback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Center For Sensory-Motor Interaction
Aalborg, 9000
About this study
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.
Read the 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.
- Being tested
- Neurofeedback, Sham
- Keywords
- Pain, Chronic Pain, Musculoskeletal Pain, Treatment, Neurofeedback, Brain Activity, Brain Oscillation, Brain Computer Interface
- Medical subject headings
- Tennis Elbow, Musculoskeletal Pain, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackProcedure or surgery
The patients will receive neurofeedback on pain related brain-activity, and through training, learn to control said brain-activity.
ShamProcedure or surgery
The patients will receive sham neurofeedback on non-pain related brain-activity, and through training, learn to control said brain-activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
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.
Measured: Up to three months
Electromyographic (EMG) measurement.
EMG electrodes will be applied to the Extensor Carpi Radials Brevis (ECRB) muscle, to provide movement temporal features for EEG extraction.
Measured: Up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Sep 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Mrachacz-Kersting, Aalborg University
- Investigators
- Natalie Mrachacz Kersting, Dr, Study director, Aalborg University, Department of Health Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863847
- Sponsor's protocol ID
- N-20140041
- Status last verified
- Mar 2019
- First submitted
- 2 Jan 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently this study is under IP at Aalborg University and thus data cannot be shared at this point.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neurofeedback Treatment for Chronic Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT03863847
- Acronym / sponsor ID
- N-20140041
- Keywords
- Pain, Chronic Pain, Musculoskeletal Pain, Treatment, Neurofeedback, Brain Activity, Brain Oscillation, Brain Computer Interface
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Neurofeedback | Active comparator | Procedure: NeurofeedbackThis 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 comparator | Procedure: ShamThis 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackThe patients will receive neurofeedback on pain related brain-activity, and through training, learn to control said brain-activity. | Procedure or surgery | Online Neurofeedback |
| ShamThe patients will receive sham neurofeedback on non-pain related brain-activity, and through training, learn to control said brain-activity. | Procedure or surgery | Online Sham Neurofeedback |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 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)
2 secondary outcomes
Electroencephalographic (EEG) measurement. International 10-20 electrode placement with 10 channels placed on the contralateral hemisphere to the dominant limb being tested.
Time frame: Up to three months
Electromyographic (EMG) measurement.
Time frame: Up to three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Individual participant dataSharing planned: No. Currently this study is under IP at Aalborg University and thus data cannot be shared at this point.
Related trials for Chronic Musculoskeletal Pain
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain
Osteoarthritis, Knee, Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Mrachacz Kersting, Dr study director
Aalborg University, Department of Health Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Chronic Musculoskeletal Pain and Tennis Elbow, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalie Mrachacz Kersting, Dr (+4599407571, nm@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: Up to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.