Pain Resilience Therapy for Low Back Pain. (Resilience)

May 27, 2026 updated by: Integrative Pain Science Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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

  1. = Hardly noticeable pain
  2. = Noticeable pain, but does not interfere with activities
  3. = Somewhat distracting pain
  4. = Distracting pain, but does not affect normal activities
  5. = Pain interrupts some activities
  6. = Hard to ignore pain, avoidance of daily activities
  7. = Pain is the main focus of attention, prevents daily activities
  8. = Awful pain, difficult to do anything
  9. = Unbearable pain, cannot do anything
  10. = As bad as pain can be, nothing else matters
At baseline (pre-intervention) and at 90-day follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At baseline (pre-intervention) and at 90-day follow-up.
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.
At baseline (pre-intervention) and at 90-day follow-up.
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.
At baseline (pre-intervention) and at 90-day follow-up.
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).
At baseline (pre-intervention) and at 90-day follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Integrative Pain Science Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kerstin Palombero, PhD, Widener University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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