Pain Resilience Therapy for Low Back Pain.

NCT06971809 | Completed

• 1 other identifier: IRB #180-23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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?

Conditions

Chronic Low Back Pain (CLBP)

Outcome Measures

Primary Outcomes (1)

• 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 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 Outcomes (4)

• Pain Resilience Scale

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

• The Defense and Veterans Pain Rating Scale (DVPRS 2.0)

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

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

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

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

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

Study Arms (2)

Fear group

ACTIVE COMPARATOR

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

Behavioral: Pain education

Strengths group

ACTIVE COMPARATOR

This group addresses the positive valance system for reward learning

Behavioral: Pain resilience

Interventions

Pain resilience BEHAVIORAL

A strengths-based approach to pain recovery

Strengths group

Pain education BEHAVIORAL

A health literacy approach

Fear group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integrative Pain Science Institute: lead

Study Sites (1)

Integrative Pain Science Institute

New York, New York, 10011, United States

Location

Related Publications (2)

• 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;103(10):pzad077. doi:10.1093/ptj/pzad077

  BACKGROUND

• 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

  BACKGROUND

Study Officials

• Kerstin Palombero, PhD

  Widener University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: May 14, 2025
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 31, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: June 2025-June 2026
• 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.

Locations

US (1)