Mobile Neurofeedback for Chronic Lower Back Pain

(NINR Trial)

Overseen By Betsy Serrano

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Seizures, Pain surgery, Implanted devices, others

Compensation: Varies

Number of Visits: 11

Duration: 12 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve treatment methods for chronic lower back pain using a mobile neurofeedback app. Participants will use the app with a headset to train the brain to relax, potentially easing pain. The study requires participants to use the app for 10 minutes, four times a week, for three months, with researchers conducting regular check-ins. Individuals who have experienced ongoing lower back pain for over three months and have felt it at least half the days in the past six months might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance pain management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the study team or your doctor.

What prior data suggests that this mobile neurofeedback technique is safe for chronic lower back pain?

Research has shown that neurofeedback is generally well-tolerated by people with chronic pain. One study tested this method and found it safe, with no serious side effects. Another review examined various studies on neurofeedback and found no major safety concerns. Most participants experienced only minor issues, such as slight discomfort from wearing the headset.

This treatment is already used in some cases to help manage chronic pain, and no major safety problems have been reported. This suggests that the treatment is likely safe for most people. However, discussing any concerns with a doctor before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mobile neurofeedback treatment for chronic lower back pain because it offers a unique approach compared to traditional methods like medication and physical therapy. This innovative technique uses mobile technology to provide real-time feedback to patients, helping them manage their pain more effectively through self-regulation. Unlike typical treatments that primarily address symptoms, this method empowers patients to actively participate in their pain management, potentially leading to more sustainable relief. Additionally, the mobile aspect makes it more accessible, allowing patients to integrate it into their daily lives without the need for frequent clinical visits.

What evidence suggests that mobile neurofeedback is effective for chronic lower back pain?

Research has shown that neurofeedback, a method that trains the brain to relax, can reduce pain and improve life quality for people with chronic pain. Many studies have found that patients using neurofeedback experienced significant relief and required less medication. One study showed that participants using neurofeedback increased their brain's resting alpha waves, which are linked to relaxation. Another study found that many people with chronic pain, such as those with low back pain, could use mobile neurofeedback independently and noticed benefits after three months. This trial will compare the effects of mobile neurofeedback, provided to participants in the experimental condition, with a sham-control arm. However, not all studies found a significant reduction in pain, so results can vary. ^{1 2 3 4 5}

Who Is on the Research Team?

Eric Elbogen, Ph.D.

Principal Investigator

Duke - Professor in Psychiatry and Behavioral Sciences

Are You a Good Fit for This Trial?

This trial is for people who have had ongoing lower back pain for more than three months and experience it on most days over the past six months. It's not suitable for those with a history of seizures, planned pain-related surgery soon, implanted medical devices like pacemakers that could be affected by EEG/ECG, or if their pain is tied to legal claims.

Inclusion Criteria

The study will use specific questions to determine if you have chronic low back pain. If you have had back pain for more than 3 months and it has been a problem for at least half the days in the past 6 months, you will be considered to have chronic low back pain.

I've had low back pain on most days for the past 6 months.

You have had ongoing low back pain for more than 3 months.

Exclusion Criteria

I have a history of seizures.

You have a medical device, like a pacemaker or spinal cord stimulator, that could be affected during the study tests.

My pain level in the past week was less than 4 on a scale of 0 to 10.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete eligibility assessment, physical function test, self-report questionnaires, and EEG

1 week

1 visit (in-person)

Treatment

Participants use the mobile neurofeedback app for 10 minutes, four times a week for 12 weeks

12 weeks

6 check-in calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment with self-report questionnaires, physical function test, and EEG

24 weeks

3 visits (in-person) at 12, 24, and 36 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neurofeedback
• Promoting Effective Self-Management of Chronic Pain with mHealth Neurofeedback
• Sham (Placebo Control)

Trial Overview The study tests a mobile app and headset designed to train the brain towards relaxation as a treatment for chronic low back pain. Participants will use these tools four times weekly for three months and share feedback at set intervals throughout the study.

How Is the Trial Designed?

Group I: Experimental Condition Experimental Treatment 1 Intervention

Mobile Neurofeedback intervention arm

Group II: Control Condition Placebo Group 1 Intervention

Sham-control arm

Neurofeedback is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Neurofeedback for:

• Chronic low back pain
• Fibromyalgia
• Neuropathic pain

Approved in European Union as Neurofeedback for:

• Chronic pain
• Fibromyalgia
• Neuropathic pain

Approved in Canada as Neurofeedback for:

• Chronic pain
• Fibromyalgia

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

In a study of 15 fibromyalgia patients undergoing 40 EEG biofeedback sessions, significant improvements were observed in visual attention and certain somatic symptoms like tenderness, pain, and fatigue.

The EEG biofeedback training, which targeted specific brainwave patterns, suggests a potential therapeutic approach for addressing attention deficits and somatic symptoms in fibromyalgia, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EEG biofeedback treatment improves certain attention and somatic symptoms in fibromyalgia: a pilot study. Caro, XJ., Winter, EF.[2022]

Neurofeedback (NFB) has been shown to be a safe and effective therapy for reducing pain in chronic pain patients, with a medium overall effect size of -0.76 based on 21 studies, including randomized controlled trials and case series.

The therapy not only alleviates pain but also improves associated symptoms like depression, anxiety, and sleep disturbances, making it a promising non-pharmacological option for patients who may not respond well to traditional medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of neurofeedback in the management of chronic pain: A systematic review and meta-analysis of clinical trials. Patel, K., Sutherland, H., Henshaw, J., et al.[2022]

Eighteen patients with chronic low back pain underwent EMG biofeedback training, resulting in a significant reduction in muscle tension and pain compared to a control group of seven patients.

While muscle tension levels returned to baseline after training, patients who experienced greater pain reduction during training continued to show improvement at follow-up, highlighting the role of cognitive factors in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of EMG biofeedback training in low back pain. Nouwen, A., Solinger, JW.[2019]

In a study of 60 participants with chronic low back pain, electroencephalographic infraslow neurofeedback (EEG ISF-NF) targeting the pregenual anterior cingulate cortex (pgACC) significantly improved effective connectivity to the somatosensory cortex (S1L) at one-month follow-up, compared to a sham treatment.

Changes in effective connectivity from pgACC to S1L were negatively correlated with pain severity, suggesting that enhancing this neural connection through ISF-NF training may help reduce pain in individuals with chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infraslow Neurofeedback Training Alters Effective Connectivity in Individuals with Chronic Low Back Pain: A Secondary Analysis of a Pilot Randomized Placebo-Controlled Study. Adhia, DB., Mani, R., Turner, PR., et al.[2022]

In a randomized, double-blind, placebo-controlled trial involving 34 fibromyalgia patients, the Low Energy Neurofeedback System (LENS) showed some improvements in symptoms, but there were no significant differences between the active and sham treatments at post-treatment or follow-ups.

While LENS alone is not recommended as a standalone treatment for fibromyalgia, the study suggests that it may have potential when used alongside other therapies, indicating a need for further research into its synergistic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurotherapy of fibromyalgia? Nelson, DV., Bennett, RM., Barkhuizen, A., et al.[2022]

Neurofeedback (NF) shows promise as a treatment for chronic pain, with 24 studies reviewed indicating potential reductions in pain intensity and improvements in related outcomes, particularly using EEG-based NF protocols.

Despite the generally positive results, the evidence is not strong enough to recommend specific NF protocols or methods, highlighting the need for further high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback for Pain Management: A Systematic Review. Roy, R., de la Vega, R., Jensen, MP., et al.[2020]

In a study involving 16 adults with chronic pain, a home-based neurofeedback (NFB) device showed promising results, with 11 participants reporting pain relief and 8 experiencing clinically significant improvements after 32-48 training sessions over 8 weeks.

The NFB training led to significant reductions in central sensitization symptoms, improved sleep quality by nearly 50%, and decreased anxiety by 40%, all without any reported adverse events, indicating its safety and potential efficacy for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based EEG Neurofeedback Intervention for the Management of Chronic Pain. Birch, N., Graham, J., Ozolins, C., et al.[2022]

Surface electromyography (SEMG) biofeedback provides real-time insights into muscle activity, allowing patients and clinicians to better understand and control muscle function, which is not achievable through traditional methods like palpation.

SEMG biofeedback can effectively help patients with chronic low back pain by either reducing excessive muscle activity or strengthening weak muscles, making it a valuable tool in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surface Electromyographic (SEMG) Biofeedback for Chronic Low Back Pain. Neblett, R.[2022]

A study involving 608 participants across 28 experiments found that including a pre-training no-feedback run significantly improves neurofeedback performance, likely by helping participants become familiar with the setup and tasks.

Patients showed better neurofeedback performance than healthy participants, possibly due to higher motivation and the need to regulate dysfunctional brain signals, suggesting that tailoring neurofeedback interventions for clinical populations could enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of real-time fMRI neurofeedback performance and improvement - A machine learning mega-analysis. Haugg, A., Renz, FM., Nicholson, AA., et al.[2021]

Neurofeedback can lead to lasting improvements in symptoms for weeks after the intervention, indicating its potential as a long-term clinical tool.

The study suggests that future neurofeedback research should include follow-up assessments over extended periods to accurately capture the timing and extent of symptom changes, as many current studies do not account for this delayed response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time course of clinical change following neurofeedback. Rance, M., Walsh, C., Sukhodolsky, DG., et al.[2021]

Citations

1. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1369487/full

Evaluating the effectiveness of neurofeedback in chronic ... Several studies report significant reductions on pain intensity, improved quality of life, and decreased reliance on medication following ...

2. jpain.org jpain.org/article/S1526-5900(24)00601-1/fulltext

Home-based EEG Neurofeedback for the Treatment ... This is the first double-blind randomized sham-controlled trial of its kind for chronic pain. The active group successfully upregulated resting relative alpha ...

3. mdpi.com mdpi.com/2077-0383/13/10/2813

A Scoping Review of the Effect of EEG Neurofeedback on ... Two other studies, however, did not report a significant pain reduction, both including chronic low back-pain patients [41,42]. More specifically, Shimizu et al ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05669027

NCT05669027 | Mobile Neurofeedback for Low Back Pain The purpose of this study is to learn more about improving the quality of treatments for people who have chronic low back pain.

5. reporter.nih.gov reporter.nih.gov/search/ty-fsXlJcUWJoLFkOlxELw/project-details/11060947

Project Details - NIH RePORTER Patients with chronic pain, most with low back pain, were able to conduct mobile neurofeedback independently, and after three months of use, reported ...