Online Pain Management Program for Chronic Back/Neck Pain

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wayne State University

Disqualifiers: Cancer, Systemic infection, Rheumatoid arthritis, others

Trial Summary

What is the purpose of this trial?

This trial tests if an online educational session about brain and emotions, combined with a writing exercise about trauma, can help adults aged 18-75 with chronic back or neck pain. The goal is to see if these activities can change how they think about their pain and reduce their emotional distress, leading to better pain management.

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for chronic back/neck pain?

Research shows that programs combining education and stress reduction, like heart coherence training and back school, can improve physical functioning and reduce pain and disability in chronic low back pain patients. Additionally, pain neuroscience education has been effective in improving pain and disability outcomes in similar conditions. ^{1 2 3 4 5}

Is the Online Pain Management Program for Chronic Back/Neck Pain safe for humans?

The technique of written emotional disclosure, which is part of the program, has been tested in several studies and is generally considered safe. It may increase physiological responses like heart rate and skin conductance during the process, but these effects are not harmful and can lead to psychological and physical health benefits. ^{6 7 8 9 10}

What makes the Online Pain Management Program for Chronic Back/Neck Pain unique compared to other treatments?

This treatment is unique because it combines psychological approaches like Pain Psychology Neuroscience and Written Emotional Disclosure with behavioral strategies such as Healthy Habits Disclosure. It focuses on both emotional and behavioral aspects of chronic pain, which may offer a more comprehensive approach than traditional treatments that often focus solely on physical symptoms. ^{1 3 11 12 13}

Research Team

Mark Lumley, PhD

Principal Investigator

Wayne State University

Eligibility Criteria

This trial is for English-speaking individuals in the USA, UK, or Australia who have had chronic musculoskeletal back or neck pain for over a year. They must have access to a computer or smartphone. People with serious diseases like cancer, significant structural damage causing pain, severe limb pain compared to back/neck pain, rheumatoid arthritis, fibromyalgia, or active psychosis cannot join.

Inclusion Criteria

Have access to a computer or smartphone

I have had back or neck pain for more than a year.

English speaking

Exclusion Criteria

I have a serious condition like cancer, a systemic infection, or major vision problems.

I am being considered for spine treatment like injections or surgery.

I have rheumatoid arthritis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Treatment

Participants are randomized to either pain neuroscience education or health behavior intervention, followed by a written emotional disclosure task or healthy habits writing task

1 week

Online activities

Follow-up

Participants are monitored for changes in pain severity, pain interference, psychological distress, and psychological attitudes toward pain

5 weeks

Online assessments

Treatment Details

Interventions

• HBC + HHD (Behavioural Intervention)
• HBC + WED (Behavioural Intervention)
• Health Behavior Control + Healthy Habits Disclosure (Behavioural Intervention)
• Health Behavior Control + Written Emotional Disclosure (Behavioural Intervention)
• Pain Psychology Neuroscience + Healthy Habits Disclosure (Behavioural Intervention)
• Pain Psychology Neuroscience + Written Emotional Disclosure (Behavioural Intervention)
• PPN + HHD (Behavioural Intervention)
• PPN + WED (Behavioural Intervention)

Trial Overview The study tests if an online educational program on pain and affect neuroscience combined with writing tasks can help people with chronic back/neck pain. Participants are randomly placed into groups that either learn about their condition and express emotions through writing or engage in general health activities and write about healthy habits.

Participant Groups

Group I: Pain Psychology Neuroscience+ Written Emotional Disclosure Experimental Treatment 1 Intervention

Pain Neuroscience Education exercise followed by Written Emotional Disclosure

Group II: Health Behavior + Written Emotional Disclosure Active Control 1 Intervention

Health behavior education followed by written emotional disclosure

Group III: Pain Psychology Neuroscience + Healthy Habits Disclosure Active Control 1 Intervention

Pain Neuroscience Education followed by Healthy Habits writing

Group IV: Health Behavior + Healthy Habits Disclosure Placebo Group 1 Intervention

Health behavior intervention followed by healthy habits writing

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

Amanda Bryant-Friedrich

Wayne State University

Chief Executive Officer since 2023

PhD in Pharmaceutical Sciences

Dr. Polsky

Wayne State University

Chief Medical Officer since 2023

MD from Wayne State University

The New School for Social Research

Collaborator

Trials

9

Recruited

3,200+

Findings from Research

A study involving 170 patients with chronic non-specific low back pain found that adding heart coherence training (HCT) to a back school program led to greater improvements in physical functioning compared to the back school alone, although this was not statistically significant after further analysis.

The study showed moderate correlations between improvements in heart coherence and reductions in pain disability, suggesting that heart coherence may play a role in enhancing treatment outcomes, but further controlled studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart coherence training combined with back school in patients with chronic non-specific low back pain: first pragmatic clinical results. Soer, R., Vos, D., Hofstra, B., et al.[2014]

The Back School program, designed for patients with chronic low back pain, focuses on educating individuals about the emotional, cognitive, and environmental factors that contribute to their pain, alongside physical training.

Results indicate that this educational approach can lead to positive outcomes in managing chronic low back pain, as evaluated through a pretest-post-test-control group design with an 8-week follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A back school in The Netherlands: evaluating the results. Keijsers, JF., Groenman, NH., Gerards, FM., et al.[2019]

The study involved 45 patients with chronic low back pain who participated in a pain control course that included education about pain and self-hypnosis, but neither component showed a significant difference in effectiveness on pain intensity or psychological measures.

While the treatment did not significantly reduce pain intensity, it led to meaningful improvements in coping strategies and psychological well-being, suggesting that teaching patients to manage their pain may be a more realistic goal than solely focusing on pain reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education and self-hypnosis in the management of low back pain: a component analysis. Spinhoven, P., Linssen, AC.[2019]

A back school program for healthcare workers with low back pain showed significant benefits, with 55% of participants reporting reduced or resolved pain and a 57.8% reduction in overall absenteeism after 4 years.

92% of participants were satisfied with the training, and 70% continued to apply the advice in their daily lives, indicating lasting positive effects on both pain management and job satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term assessment of a sanitary education and lumbar rehabilitation program for health care workers with chronic low back pain at the University Hospital of Lille. Sobaszek, A., Fantoni-Quinton, S., Delval, M., et al.[2019]

Pain neuroscience education (PNE) combined with physiotherapy shows moderate evidence of improving short-term disability and pain in patients with chronic low back pain (CLBP), based on a meta-analysis of 8 trials involving 615 participants.

While PNE appears effective in the short term, the analysis did not find evidence of long-term benefits for pain or disability when PNE was added to standard physiotherapy treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Wood, L., Hendrick, PA.[2019]

Undergraduate students with migraine headaches who had better emotional skills showed greater improvement in their condition after participating in written emotional disclosure (WED) compared to those who underwent relaxation training or control writing.

Low headache management self-efficacy (HMSE) was associated with improvements in both WED and relaxation training, suggesting that individuals with less confidence in managing their headaches can still benefit from these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotional approach coping and self-efficacy moderate the effects of written emotional disclosure and relaxation training for people with migraine headaches. Kraft, CA., Lumley, MA., D'Souza, PJ., et al.[2021]

Written emotional disclosure of trauma can increase pain sensitivity in healthy women, as evidenced by heightened negative emotions and physiological responses during pain tests.

Women with a history of trauma showed lower pain tolerance under neutral conditions, but this was improved after disclosing their trauma, suggesting that emotional processing can influence pain modulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Written emotional disclosure of trauma and trauma history alter pain sensitivity. Creech, SK., Smith, J., Grimes, JS., et al.[2015]

Emotional disclosure techniques, such as writing or speaking about feelings, show modest benefits for chronic pain management, with some evidence suggesting potential advantages for fibromyalgia patients, while effects in rheumatoid arthritis and other pain conditions are limited or mixed.

Further research is needed to understand how to effectively implement emotional disclosure in clinical practice, including identifying which patients may benefit most and the best methods for delivering this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotional disclosure interventions for chronic pain: from the laboratory to the clinic. Lumley, MA., Sklar, ER., Carty, JN.[2022]

Written emotional disclosure can influence pain sensitivity, particularly in women with a history of trauma, showing an initial increase in secondary hyperalgesia one day after writing, but a significant reduction one month later.

The study suggests that using positive emotional language during disclosure is associated with reduced pain sensitivity over time, indicating that emotional processing may have long-term benefits for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of written emotional disclosure on secondary hyperalgesia in women with trauma history. You, DS., Creech, SK., Vichaya, EG., et al.[2014]

Writing about personal stressful events leads to greater emotional and physiological benefits compared to neutral writing, as shown in a study with 246 participants who engaged in writing exercises over three sessions.

Response training, which enhances physiological reactions during emotional writing, was found to further improve outcomes, with participants showing greater reductions in distress, depression, and physical symptoms, particularly when their heart rate increased during the writing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the benefits of written emotional disclosure through response training. Konig, A., Eonta, A., Dyal, SR., et al.[2021]

In a study of 64 subjects with chronic neck pain, combining pain neuroscience education with cognition-targeted motor control training showed significant improvement in neuromuscular control of deep cervical flexors after 3 months, indicating a potential benefit in this specific area.

However, this combined treatment was not found to be more effective than traditional biomedical education and exercise therapy for overall cervical motor output, suggesting that factors like pain and disability may not significantly impact motor control improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Pain Neuroscience Education and Cognition-Targeted Motor Control Training Improve Cervical Motor Output? Secondary Analysis of a Randomized Clinical Trial. Willaert, W., Malfliet, A., Coppieters, I., et al.[2020]

A single-session telehealth class called 'Pain, Stress, and Emotions' (PSE) using Emotional Awareness and Expression Therapy (EAET) significantly reduced pain intensity and interference in 74 adults with chronic pain, with a medium effect size of 0.60 at 4 weeks.

Participants reported high satisfaction with the PSE class, and one-quarter experienced clinically meaningful pain reduction, suggesting that this easily delivered intervention could be beneficial for managing chronic pain, although further controlled studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Pain, Stress, and Emotions": Uncontrolled trial of a single-session, telehealth, emotional awareness and expression therapy class for patients with chronic pain. Ziadni, MS., Sturgeon, JA., Lumley, MA.[2023]

A standardized self-control training program for chronic pain patients, involving techniques like progressive muscle relaxation and pain-control strategies, led to significant improvements in pain intensity and mood among 33 participants after 12 group sessions.

Patients who received the treatment also experienced a notable decrease in depression and other physical complaints, with these benefits maintained at a six-month follow-up, while those on the waiting list showed no changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Self-control training for patients with chronic pain.]. Kaluza, G., Basler, HD.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Heart coherence training combined with back school in patients with chronic non-specific low back pain: first pragmatic clinical results. [2014]

2. Ireland pubmed.ncbi.nlm.nih.gov

A back school in The Netherlands: evaluating the results. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Education and self-hypnosis in the management of low back pain: a component analysis. [2019]

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

Long-term assessment of a sanitary education and lumbar rehabilitation program for health care workers with chronic low back pain at the University Hospital of Lille. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. [2019]

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

Emotional approach coping and self-efficacy moderate the effects of written emotional disclosure and relaxation training for people with migraine headaches. [2021]

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

Written emotional disclosure of trauma and trauma history alter pain sensitivity. [2015]

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

Emotional disclosure interventions for chronic pain: from the laboratory to the clinic. [2022]

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

Effect of written emotional disclosure on secondary hyperalgesia in women with trauma history. [2014]

10. England pubmed.ncbi.nlm.nih.gov

Enhancing the benefits of written emotional disclosure through response training. [2021]

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

Does Pain Neuroscience Education and Cognition-Targeted Motor Control Training Improve Cervical Motor Output? Secondary Analysis of a Randomized Clinical Trial. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

"Pain, Stress, and Emotions": Uncontrolled trial of a single-session, telehealth, emotional awareness and expression therapy class for patients with chronic pain. [2023]

13. Germany pubmed.ncbi.nlm.nih.gov

[Self-control training for patients with chronic pain.]. [2021]