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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn more about improving the quality of treatments for people who have chronic low back pain. Participants will complete interviews with Duke researchers at four different time points: the beginning of the study, at 3 months, at 6 months, and at 9 months. Participants will be asked to use a mobile app and a headset that are designed to train the brain to be more relaxed. Participants will use the mobile app for 10 minutes at a time, four times a week for three months. The study team will also check in with participants about app use six times throughout the study, via phone or video conference.

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 data supports the effectiveness of the treatment Mobile Neurofeedback for Chronic Lower Back Pain?

Research suggests that neurofeedback, a technique that helps people control their brain activity, can help manage chronic pain by improving brain function. In particular, infraslow neurofeedback has shown promise in reducing pain by altering brain connectivity in people with chronic low back pain. ^{1 2 3 4 5}

Is neurofeedback safe for humans?

Neurofeedback, including EEG and fMRI-based methods, has been studied for various conditions and is generally considered safe for humans. While the effectiveness can vary, no significant safety concerns have been reported in the studies reviewed. ^{1 2 5 6 7}

How does mobile neurofeedback treatment differ from other treatments for chronic lower back pain?

Mobile neurofeedback treatment is unique because it uses brainwave monitoring to help patients manage chronic pain by normalizing brain activity, which is different from traditional treatments that focus on physical symptoms or medication. This approach allows patients to gain control over their pain through a non-invasive, self-managed method that can be done at home. ^{1 5 8 9 10}

Research Team

Eric Elbogen, Ph.D.

Principal Investigator

Duke - Professor in Psychiatry and Behavioral Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Home-Based EEG Neurofeedback Intervention for the Management of Chronic Pain. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Predictors of real-time fMRI neurofeedback performance and improvement - A machine learning mega-analysis. [2021]

3. Switzerland 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Time course of clinical change following neurofeedback. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

EEG biofeedback treatment improves certain attention and somatic symptoms in fibromyalgia: a pilot study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effects of neurofeedback in the management of chronic pain: A systematic review and meta-analysis of clinical trials. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Neurofeedback for Pain Management: A Systematic Review. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Neurotherapy of fibromyalgia? [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of EMG biofeedback training in low back pain. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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