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Completed

NCT Number: NCT06971809

Pain Resilience Therapy for Low Back Pain.

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?

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Pain Science Institute

New York, 10011, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults experiencing chronic low back pain of any diagnosis for a duration of at least 6 months.
  • Ability to read and understand English.
  • 18-85 years of age Exclusion Criteria
  • Experiencing acute pain related to a recent injury or pain lasting less than 6 months.
  • Inability to read or understand English.
  • History of metastatic cancer

Treatment and study plan

Pain resilience

Behavioral

A strengths-based approach to pain recovery

Pain education

Behavioral

A health literacy approach

Primary outcomes

  1. Pain intensity

    Time frame: At baseline (pre-intervention) and at 90-day follow-up.

    Pain intensity will be measured by the Defense of Veterans Pain Rating Scale. This is a numerical scale with descriptors

    0 = No pain

    • = Hardly noticeable pain
    • = Noticeable pain, but does not interfere with activities
    • = Somewhat distracting pain
    • = Distracting pain, but does not affect normal activities
    • = Pain interrupts some activities
    • = Hard to ignore pain, avoidance of daily activities
    • = Pain is the main focus of attention, prevents daily activities
    • = Awful pain, difficult to do anything
    • = Unbearable pain, cannot do anything
    • = As bad as pain can be, nothing else matters

Secondary outcomes

  1. Pain Resilience Scale

    Time frame: At baseline (pre-intervention) and at 90-day follow-up.

    The Pain Resilience Scale (PRS), is a questionnaire measuring your ability to maintain positive functioning (emotions, thoughts, actions) despite intense or chronic pain, focusing on Behavioral Perseverance (pushing through) and Cognitive/Affective Positivity (staying positive). It's a 14-item tool where you rate how much certain statements describe you (0-4 scale), predicting better coping, less catastrophizing, and improved quality of life compared to general resilience measures. The PRS was developed as a pain-specific measure of resilience, and its validity within the chronic pain population is superior to general resilience scales. It has high internal consistency (Cronbach's α = .94) and high test-retest reliability (r = .79).47 The PRS provides a total score, along with two distinct subscales for cognitive/affective positivity and behavioral perseverance.

  2. The Defense and Veterans Pain Rating Scale (DVPRS 2.0)

    Time frame: At baseline (pre-intervention) and at 90-day follow-up.

    The Defense and Veterans Pain Rating Scale (DVPRS 2.0) is a pain assessment tool that utilizes a numerical rating scale (0-10) enhanced by functional word descriptors, color coding, and pictorial facial expressions matched to pain levels. The Defense and Veterans Pain Rating Scale (DVPRS 2.0) was used to measure pain intensity and pain interference with activity, sleep, mood, and stress. The DVPRS is a reliable (Cronbach's α = 0.871) and valid instrument that provides standard language and metrics to communicate pain and related outcomes. Lower scores indicate less pain intensity and pain interference. It has been recommended for veteran as well as civilian populations.

  3. Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference

    Time frame: At baseline (pre-intervention) and at 90-day follow-up.

    Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference Short Form 6b was also used to measure pain interference. The PROMIS® is a reliable (Cronbach's α = 0.88 to 0.97) self-report measure of the consequences of pain on relevant aspects of a person's life and how pain hinders social, cognitive, emotional, physical, and recreational engagement. The Minimal Clinically Important Difference (MCID) for the PROMIS® is estimated to be 3.0 T-score points for pain samples representing the smallest meaningful improvement for this population. Lower scores indicate less pain interference.

  4. Optimal Screening for Prediction of Referral and Outcome-Yellow Flag (OSPRO-YF)

    Time frame: At baseline (pre-intervention) and at 90-day follow-up.

    The Optimal Screening for Prediction of Referral and Outcome-Yellow Flag (OSPRO-YF) is an assessment tool designed to help orthopedic physical therapy clinicians screen patients and clients for psychosocial distress. Test items assess depression, anxiety, kinesiophobia, anger, fear-avoidance beliefs, catastrophizing, self-efficacy, and pain acceptance. As OSPRO-YF summarizes 11 psychological questionnaires, it is not scored like a conventional screening tool. Quartile scores are used instead of cutoff scores for consistency and assessment. Scores that are in the top quartile (top 25%) for negative psychological questionnaires (Negative Mood and Fear Avoidance questionnaires) Scores that are in the bottom quartile (bottom 25%) for positive psychological questionnaires (Positive Affect/Coping questionnaires).

Sponsors and collaborators

Lead sponsor

Integrative Pain Science Institute

Industry

Registry information

Official study title

Efficacy of a Multi-modal Pain Resilience Approach to Chronic Low Back Pain

Acronym: Resilience

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 14, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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