What is the mechanism of action of this treatment?

Pain Reprocessing Therapy (PRT) retrains the brain to interpret pain signals differently, reducing the perception of pain by altering neural pathways. Cognitive Behavioral Therapy (CBT) addresses the psychological aspects of pain by changing negative thought patterns and behaviors that contribute to pain perception and coping strategies. Usual care often includes physical therapy, medications, and lifestyle modifications to manage symptoms. Understanding these mechanisms is crucial for back pain patients as it highlights the importance of a multifaceted approach that targets both physical symptoms and psychological and neural components of pain.

What side effects are associated with this type of intervention?

Pain Reprocessing Therapy (PRT) and Cognitive Behavioral Therapy (CBT) are non-pharmacological treatments with minimal physical side effects. PRT aims to retrain the brain to interpret pain signals differently, and while specific side effects are not well-documented, it may involve temporary discomfort as patients confront and alter their pain perceptions. CBT, which addresses the psychological aspects of pain, can sometimes lead to emotional discomfort as patients work through challenging thoughts and behaviors. Usual care, which may include medications like NSAIDs, can have side effects such as gastrointestinal issues, cardiovascular risks, and potential for dependency. Overall, non-pharmacological therapies like PRT and CBT are generally considered safe with few adverse effects compared to pharmacological treatments.

What prior FDA approvals exist?

FDA-approved treatments for back pain primarily include pharmacologic options such as nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, which provide symptomatic relief. Other treatments like opioids and muscle relaxants are also used but come with significant side effects and risks. Non-pharmacologic treatments such as acupuncture and spinal manipulation have shown some efficacy but are not FDA-approved as medications. There are no specific FDA-approved drugs that focus on retraining the brain to interpret pain signals differently, similar to Pain Reprocessing Therapy (PRT).

What other types of research exist?

Promising alternatives to Pain Reprocessing Therapy (PRT) for back pain patients include Cognitive Behavioral Therapy (CBT), guided imagery, progressive muscle relaxation, and biofeedback. These therapies have shown efficacy in managing chronic pain and may offer benefits in 2024.

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Pain Reprocessing Therapy for Chronic Back Pain

N/A

Recruiting

Led By Jonathan K. Ashar, Ph.D.

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Back pain that is worse than leg pain

Last-week average back pain of at least 4 of 10 at the two pretreatment timepoints (online pre-screening and informed consent session)

Must not have

Recent large unexplained, unintended weight loss (20lbs or more)

Major surgery or other major medical event planned in coming six months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up primary time point is the day after post-treatment, 1.5 months on average

Awards & highlights

No Placebo-Only Group

Summary

This trial compares three treatments for chronic pain: a new therapy (PRT), a well-known therapy (CBT), and usual care. It focuses on adults with chronic pain, especially those from diverse and lower-income backgrounds. PRT aims to change how patients perceive their pain, making it seem less threatening and more manageable.

Who is the study for?

This trial is for adults with chronic back pain lasting at least 6 months, where the back pain is more frequent and severe than leg pain. Participants must have a consistent level of pain and be able to attend telehealth appointments. Those with recent major medical events, surgeries, or psychiatric issues, or who are involved in litigation related to their pain cannot join.

What is being tested?

The study compares Pain Reprocessing Therapy (PRT), Cognitive Behavioral Therapy (CBT) for Chronic Pain, and usual care to determine which method best reduces chronic back pain and improves associated problems. It aims to find out if PRT can effectively lower chronic pain compared to CBT or ongoing treatments.

What are the potential side effects?

Since this trial involves therapy sessions rather than medication, side effects may include emotional discomfort due to discussing painful experiences but typically do not involve physical side effects like those from drugs.

Eligibility Criteria

Inclusion Criteria

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

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My back pain is more severe than my leg pain.

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My back pain has been at least 4 out of 10 in the last week.

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I have had back pain for most days in the past 6 months.

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My back pain is more severe than my leg pain.

Exclusion Criteria

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

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I have lost 20lbs or more recently without trying.

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I do not have any major surgeries or medical events planned in the next six months.

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I have trouble controlling my bladder.

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I have feeling or movement issues in my trunk or legs.

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I have had a recent spinal fracture or have known spinal tumors.

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I have not had thoughts of harming myself or attempted suicide in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ primary time point is the day after post-treatment, 1.5 months on average

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~primary time point is the day after post-treatment, 1.5 months on average

This trial's timeline: 3 weeks for screening, Varies for treatment, and primary time point is the day after post-treatment, 1.5 months on average for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pain intensity

Session Attendance

Secondary study objectives

Anger

Anxiety

Client satisfaction

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Pain reprocessing therapy (PRT)Experimental Treatment1 Intervention

PRT has 5 components: 1) education about the origin of pain in the brain, its reversibility, and the pain-fear cycle; 2) reinforcing education using personal biography; 3) "somatic tracking" of pain through mindfulness and reappraisal of pain sensations as non-dangerous; 4) lowering the level of personal threat that may trigger pain sensation; and 5) inducing positive affect in periods of pain. Patients will attend 1 assessment and education telehealth session with a physician followed by 8, 50-minute, therapist-led sessions. Pacing will be flexible, ranging from 5-12 weeks, to increase accessibility. Treatment will be provided by experienced PRT clinicians. All PRT sessions will be remotely-delivered.

Group II: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)Active Control1 Intervention

CBT-CP, considered the leading psychological treatment for chronic pain, is a structured, time-limited intervention that aims to teach patients how to better manage chronic pain and improve their quality of life. Participants will receive 9, 50-minute sessions of CBT-CP over 5 - 12 weeks. The VA CBT-CP protocol contains an initial orientation involving education and familiarization with the CBT-CP approach to chronic pain. The protocol then includes sessions that focus on topics such as exercise, relaxation, pleasant activities, cognitive coping, and sleep. All CBT-CP sessions will be remotely-delivered.

Group III: Usual CareActive Control1 Intervention

Participants will be asked to continue whatever they are already doing to care for their back pain. Length of the usual care condition will be 5 weeks, the expected mean completion time of the PRT and CBT arms, and may be adjusted at mid-enrollment to match treatment arm length more closely.

0 / 10Eligibility 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

Pain Reprocessing Therapy (PRT) retrains the brain to interpret pain signals differently, reducing the perception of pain by altering neural pathways. Cognitive Behavioral Therapy (CBT) addresses the psychological aspects of pain by changing negative thought patterns and behaviors that contribute to pain perception and coping strategies. Usual care often includes physical therapy, medications, and lifestyle modifications to manage symptoms. Understanding these mechanisms is crucial for back pain patients as it highlights the importance of a multifaceted approach that targets both physical symptoms and psychological and neural components of pain.

Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.Subgroup Perspectives on Chronic Pain and Its Management After Spinal Cord Injury.The use of high-intensity focused ultrasound as a novel treatment for painful conditions-a description and narrative review of the literature.