Clinical trial NCT06971809: Pain Resilience for Low Back Pain.
Official title: Efficacy of a Multi-modal Pain Resilience Approach to Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Low Back Pain (CLBP)
Lead sponsor: Integrative Pain Science Institute
Sponsor class: INDUSTRY
First posted: 2025-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain intensity
timeFrame: 90 days
Secondary outcomes:
measure: Optimal Screening for Prediction of Referral and Outcome-Yellow Flag (OSPRO-YF)
timeFrame: 90 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Integrative Pain Science Institute
state: New York
Study officials:
affiliation: Widener University
name: Kerstin Palombero, PhD
role: STUDY_DIRECTOR
References: