Pain Resilience for Low Back Pain

(Resilience Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Integrative Pain Science Institute

Disqualifiers: Acute pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining pain education with other treatments can help people with chronic pain more effectively than pain education alone. The aim is to determine if a whole-person approach, including physical therapy and cognitive behavioral techniques, offers greater benefits. The trial includes two groups: one focuses on reducing fear and threat, while the other enhances positive experiences and builds pain resilience. Adults who have experienced chronic pain for at least six months and can read and understand English might be suitable candidates for this trial. As an unphased study, this trial provides a unique opportunity to explore innovative approaches to managing chronic pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining pain education with treatments like physical therapy and cognitive behavioral techniques can be safe and helpful for people with chronic pain. Studies have found that exercises to improve movement can reduce pain and disability. When combined with other treatments, these exercises might offer more benefits than pain education alone.

No specific mention of serious side effects from these combined approaches suggests they are generally well-tolerated. However, as with any treatment, individual experiences may vary. Always consult a healthcare provider before starting any new treatment plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring Pain Resilience for low back pain because it emphasizes psychological interventions rather than traditional medications. Unlike standard treatments like painkillers or physical therapy, this approach focuses on the mind's role in managing pain. The Fear group targets the negative emotions associated with pain to reduce fear and perceived threat, while the Strengths group enhances positive feelings to foster reward learning. By shifting the focus from just physical symptoms to emotional resilience, this method could offer a more holistic way to manage chronic pain.

What evidence suggests that this trial's treatments could be effective for low back pain?

This trial will compare two approaches to building pain resilience for individuals with chronic low back pain. Research has shown that resilience to pain, which involves staying positive and managing pain effectively, can improve well-being for those with chronic low back pain. Studies have found that more resilient individuals often recover better and experience less severe pain. Participants in the "Fear group" will receive interventions targeting the negative valence system to decrease fear and threat. Meanwhile, the "Strengths group" will focus on the positive valence system for reward learning. Combining pain education with methods like physical therapy and cognitive-behavioral techniques can enhance these benefits. For example, resilience training can help change negative thoughts about pain, reducing fear and improving pain management. Overall, this approach treats the whole person and aims to provide more relief than traditional pain education alone. ^{1 5 6 7 8}

Who Is on the Research Team?

Kerstin Palombero, PhD

Principal Investigator

Widener University

Are You a Good Fit for This Trial?

This trial is for adults with chronic lower back pain who are seeking alternatives to medication. Participants should be interested in a whole-person approach that includes physical therapy, cognitive strategies, and lifestyle changes alongside pain education.

Inclusion Criteria

Ability to read and understand English

I have been experiencing chronic pain for at least 6 months.

Exclusion Criteria

Inability to read or understand English

I am experiencing pain from a recent injury or pain that has lasted less than 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multi-modal resilience approach combining pain education with physical therapy, cognitive behavioral techniques, and healthy lifestyle strategies

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pain Resilience

Trial Overview The study tests if combining pain education with resilience tactics like physical therapy and cognitive behavioral techniques offers more relief for chronic low back pain than just pain education alone.

How Is the Trial Designed?

Group I: Fear group Active Control 1 Intervention

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

Group II: Strengths group Active Control 1 Intervention

This group addresses the positive valance system for reward learning

Who Is Running the Clinical Trial?

Integrative Pain Science Institute

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06971809

Study Details | NCT06971809 | Pain Resilience for Low ... The purpose of this study is to explore whether combining pain education with other treatments-such as physical therapy, cognitive behavioral techniques, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7160029/

Pain resilience moderates the influence of negative ... We investigated whether pain resilience moderated the relationships between negative pain beliefs (fear-avoidance, pain catastrophizing) and pain outcomes.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1526590024000403

The Impact of Sociodemographic Factors on Pain ... The purpose of this study was to investigate the impact of sociodemographic factors (ie, racialized group) on pain resilience in adults with chronic low back ...

4. painphysicianjournal.com painphysicianjournal.com/current/pdf?article=Nzk5Ng%3D%3D&journal=169

Resiliency is a Predictor of Clinical Outcomes in a Chronic ... This study adds to the growing body of evidence that depicts resiliency as an important predictor of clinical outcomes. Key words: Behavioral health; pain ...

5. jospt.org jospt.org/doi/10.2519/jospt.2017.0607

Predicting Low Back Pain Outcomes: Suggestions for ... A clinically useful model for predicting LBP chronicity must be efficient with regard to both provider/patient effort and time.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12059833/

Impact of lumbar support on pain reduction in low back ... The results demonstrated a significant reduction in pain associated with lumbar support compared to alternative interventions, with an overall standardized mean ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526590024007314

Reassurance use and reassurance-related outcomes for ... This review maps the available evidence describing how patient reassurance is used and assessed in the management of low back pain.

8. jospt.org jospt.org/doi/10.2519/jospt.2021.0304

Interventions for the Management of Acute and Chronic ... Results favored movement control exercise versus control or general exercise after 3 to 4 weeks and after 12 weeks for pain and disability,,, ...