Pain Resilience for Low Back Pain.

NCT ID: NCT06971809

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-07-31

Brief Summary

Chronic pain affects about 20% of adults in the U.S. and can lead to serious personal, social, and economic challenges. It is often treated with medications, including opioids, which carry risks of dependence. While pain education (PE) helps people better understand their pain and may reduce symptoms, it generally has only modest effects when used alone.

The purpose of this study is to explore whether combining pain education with other treatments-such as physical therapy, cognitive behavioral techniques, and healthy lifestyle strategies-in a multi-modal resilience approach can offer greater benefits. The study aims to answer the following question:

Can a combined, whole-person approach improve outcomes in people with chronic pain more effectively than pain education alone?

Detailed Description

Chronic pain is pain that lasts beyond the typical healing duration, and is typically defined as lasting for at least 3-6 months. Approximately 20% of the adult U.S. population experiences chronic pain. There are a variety of risk factors for developing chronic pain. Female sex, older age, living in poverty, having chronic health conditions or a disability and being a veteran are among the risk factors for chronic pain. Chronic pain impacts quality of life as well as worker productivity. Chronic pain presents an economic burden beyond absenteeism and lost wages and costs the healthcare system upwards of $300 billion for a range of services including medication for pain management, surgeries, and disability compensation. Additionally, opioid prescription for chronic pain is a primary driver of opioid use disorder. Teaching those with chronic pain how to effectively manage their pain can improve quality of life and reduce the risk of developing dependency on opioid medication.

The non-pharmacologic and non-invasive treatment of chronic pain includes physical therapy, cognitive behavioral techniques, and strategies for promoting a healthy lifestyle. Pain education (PE) has been advocated as a methodology to reduce chronic pain. PE teaches that pain is not simply the result of tissue damage. Rather, the foundation of PE is education about the factors that can contribute to pain such as emotions, beliefs, and past experiences.4 However, PE is a singular modality that produces small effects. A multi-modal resilience approach model may produce larger effects.

Conditions

Chronic Low Back Pain (CLBP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fear group

This intervention addresses the negative valence system to decrease fear and threat.

Group Type: ACTIVE_COMPARATOR

Pain education

Intervention Type: BEHAVIORAL

A health literacy approach

Strengths group

This group addresses the positive valance system for reward learning

Group Type: ACTIVE_COMPARATOR

Pain resilience

Intervention Type: BEHAVIORAL

A strengths-based approach to pain recovery

Interventions

Pain resilience

A strengths-based approach to pain recovery

Intervention Type: BEHAVIORAL

Pain education

A health literacy approach

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults experiencing chronic pain of any diagnosis for a duration of at least 6 months.
• Ability to read and understand English.

Exclusion Criteria

• Experiencing acute pain related to a recent injury or pain lasting less than 6 months.
• Inability to read or understand English.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integrative Pain Science Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerstin Palombero, PhD

Role: STUDY_DIRECTOR

Widener University

Locations

Integrative Pain Science Institute

New York, New York, United States

Countries

United States

Other Identifiers

IRB #180-23

Identifier Type: -

Identifier Source: org_study_id