Chronic Low Back Pain (CLBP)ResilienceNCT06971809
Pain Resilience Therapy for Low Back Pain.
A study testing Pain resilience and Pain education in people with Chronic Low Back Pain (CLBP), run by Integrative Pain Science Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Pain resilience and Pain education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Pain Science Institute
New York, New York, 10011
About this study
Official title: 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?
Read the 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.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Pain resilience, Pain education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain resilienceBehavioural
A strengths-based approach to pain recovery
Pain educationBehavioural
A health literacy approach
| Study group | Role | What they receive |
|---|---|---|
| Fear group | Active comparator | This intervention addresses the negative valence system to decrease fear and threat. Receives: Behavioral: Pain education |
| Strengths group | Active comparator | This group addresses the positive valance system for reward learning Receives: Behavioral: Pain resilience |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline (pre-intervention) and at 90-day follow-up.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: At baseline (pre-intervention) and at 90-day follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start31 May 2025
- Primary completion31 Dec 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Pain Science Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerstin Palombero, PhD, Study director, Widener University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971809
- Sponsor's protocol ID
- IRB #180-23
- Acronym
- Resilience
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be shared.
Publications
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.
PubMed 37369058Tatta, 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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multi-modal Pain Resilience Approach to Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06971809
- Acronym / sponsor ID
- Resilience / IRB #180-23
- Conditions
- Chronic Low Back Pain (CLBP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Integrative Pain Science InstituteIndustry (pharma, biotech, devices)
- Study start
- 31 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fear group | Active comparator | Behavioral: Pain educationThis intervention addresses the negative valence system to decrease fear and threat. |
| Strengths group | Active comparator | Behavioral: Pain resilienceThis group addresses the positive valance system for reward learning |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain resilienceA strengths-based approach to pain recovery | Behavioural | Strengths group |
| Pain educationA health literacy approach | Behavioural | Fear group |
Primary outcome
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
4 secondary outcomes
Pain Resilience Scale
Time frame: 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.
Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 37369058Tatta 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.
- BackgroundTatta, 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
- Individual participant dataSharing planned: Yes. Study protocol will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerstin Palombero, PhD study director
Widener University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain resilience and Pain education in people with Chronic Low Back Pain (CLBP), run by Integrative Pain Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: At baseline (pre-intervention) and at 90-day follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06971809, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.