What side effects are associated with this type of intervention?

Psychological therapies for back and neck pain, such as Pain and Affect Neuroscience Education and Written Emotional Disclosure, generally have minimal physical side effects. However, patients may experience temporary emotional discomfort or distress as they confront and process painful emotions and beliefs. Additionally, there may be initial resistance or skepticism towards the effectiveness of these therapies. Overall, these treatments are considered safe and are often well-tolerated by patients.

What prior FDA approvals exist?

The FDA has approved various treatments for back and neck pain, including pharmacological and non-pharmacological approaches. While specific FDA approvals for treatments directly mirroring Pain and Affect Neuroscience Education and Written Emotional Disclosure are not detailed, cognitive-behavioral therapy (CBT) and other psychological interventions are recognized and widely used for managing chronic pain. These therapies aim to change pain beliefs and cognitive processes, similar to the mechanisms studied in the trial. Additionally, interventions like mindfulness-based stress reduction (MBSR) and other mind-body practices have shown efficacy in pain management, focusing on emotional expression and cognitive restructuring.

What other types of research exist?

Promising novel alternatives for back/neck pain treatment in 2024 include: 1) Spinal manipulation and exercise, which have shown slightly better performance in improving function and decreasing pain compared to Neuro Emotional Technique. 2) Biofeedback-assisted relaxation, which has been effective in reducing pain in cancer patients and may be applicable to back/neck pain. 3) Mindfulness-based interventions, such as Mindfulness-Based Stress Reduction (MBSR), which have been investigated for their potential to improve pain management and stress response.

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Online Pain Management Program for Chronic Back/Neck Pain

N/A

Recruiting

Research Sponsored by Wayne State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic musculoskeletal back or neck pain for greater than 1 year as primary symptom complaint

Be older than 18 years old

Must not have

Presence of serious disease or impairment (cancer, systemic infection, serious vision impairment)

Being considered for interventional spine procedures (eg, steroidal injections) or surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 5 weeks follow-up

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves education and writing tasks rather than medication or invasive procedures, traditional physical side effects are not expected. However, discussing emotional topics could potentially cause temporary distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have been diagnosed with fibromyalgia.

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My leg or arm pain is worse than my back or neck pain.

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I have a confirmed injury causing my pain, like a broken bone in my spine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 5 weeks follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 5 weeks follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 5 weeks follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brief Pain Inventory Brief Pain Inventory pain severity scale (0 - 10; higher values = greater pain severity)

Secondary study objectives

Emotional approach coping scale

General Self Efficacy Scale

Pain Catastrophizing Scale

+7 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Pain Psychology Neuroscience+ Written Emotional DisclosureExperimental Treatment1 Intervention

Pain Neuroscience Education exercise followed by Written Emotional Disclosure

Group II: Health Behavior + Written Emotional DisclosureActive Control1 Intervention

Health behavior education followed by written emotional disclosure

Group III: Pain Psychology Neuroscience + Healthy Habits DisclosureActive Control1 Intervention

Pain Neuroscience Education followed by Healthy Habits writing

Group IV: Health Behavior + Healthy Habits DisclosurePlacebo Group1 Intervention

Health behavior intervention followed by healthy habits writing

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for back/neck pain, such as Pain and Affect Neuroscience Education and Written Emotional Disclosure, work by altering pain beliefs and cognitive processes, and facilitating emotional expression and processing. These mechanisms help patients reframe their pain experience, reduce psychological distress, and improve coping strategies. Exercise therapy and cognitive behavioral therapy (CBT) also play significant roles by enhancing physical function, reducing pain sensitivity, and addressing maladaptive thoughts and behaviors. Mind-body therapies like yoga and mindfulness-based stress reduction (MBSR) integrate physical movement with mental relaxation techniques, promoting overall well-being. Understanding these mechanisms is crucial for patients as it highlights the importance of a holistic approach to pain management, addressing both physical and psychological aspects of pain.

Approaches to cervical spine mobilization for neck pain: a pilot randomized controlled trial.The comparative effects of spinal and peripheral thrust manipulation and exercise on pain sensitivity and the relation to clinical outcome: a mechanistic trial using a shoulder pain model.