Pain Resilience Therapy for Low Back Pain. (Resilience)

Efficacy of a Multi-modal Pain Resilience Approach to Chronic 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?

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain (CLBP)
• Intervention / Treatment: Behavioral: Pain education; Behavioral: Pain resilience

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10011
      • Integrative Pain Science Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fear group; This intervention addresses the negative valence system to decrease fear and threat.	Behavioral: Pain education; A health literacy approach
Active Comparator: Strengths group; This group addresses the positive valance system for reward learning	Behavioral: Pain resilience; A strengths-based approach to pain recovery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	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	At baseline (pre-intervention) and at 90-day follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Resilience Scale	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.	At baseline (pre-intervention) and at 90-day follow-up.
The Defense and Veterans Pain Rating Scale (DVPRS 2.0)	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.	At baseline (pre-intervention) and at 90-day follow-up.
Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference	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.	At baseline (pre-intervention) and at 90-day follow-up.
Optimal Screening for Prediction of Referral and Outcome-Yellow Flag (OSPRO-YF)	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).	At baseline (pre-intervention) and at 90-day follow-up.

Collaborators and Investigators

• Sponsor: Integrative Pain Science Institute
• Investigators: Study Director: Kerstin Palombero, PhD, Widener University

Publications and helpful links

General Publications

• Tatta, J., Pignataro, R., Bezner, J., & Rothschild, C. (2024). Internet-Delivered Pain Resilience Therapy: A Multi-Subject Case Series. Journal of Physiotherapy in Mental Health, 1(1), 55-79. https://doi.org/10.70205/jptmh.v1i1.9277
• Tatta J, Pignataro RM, Bezner JR, George SZ, Rothschild CE. PRISM-Pain Recovery and Integrative Systems Model: A Process-Based Cognitive-Behavioral Approach for Physical Therapy. Phys Ther. 2023 Oct 3;103(10):pzad077. doi: 10.1093/ptj/pzad077.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: May 7, 2025
• First Posted (Actual): May 14, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB #180-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol will be shared.
• IPD Sharing Time Frame: June 2025-June 2026
• IPD Sharing Access Criteria: The study protocol will be shared with qualified investigators whose aims address sound scientific questions related to pain management. Interested parties must submit a proposal outlining their planned analyses, which will be reviewed before approval. Upon acceptance, a use agreement must be signed, and data will be shared via a secure platform.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No