Pain Reprocessing Therapy for Chronic Lower Back Pain

Overseen By Meagan McBride

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Rheumatoid arthritis, Dementia, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an internet-based therapy called Brief Pain Reprocessing Therapy (BPRT) to determine its effectiveness for Veterans with chronic lower back pain. The study evaluates the therapy's usability, safety, and participant satisfaction. Veterans experiencing back pain for over six months on most days, and who have internet access, may qualify for this trial. As an unphased trial, it offers Veterans the chance to explore a new therapy that could enhance their quality of life.

Do I need to stop taking my current medications to join the trial?

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

What prior data suggests that this behavioral intervention is safe for Veterans with Chronic Low Back Pain?

Research has shown that Pain Reprocessing Therapy (PRT) is generally easy for patients to handle. In past studies, 98% of patients reported improvement, and 66% were either free of pain or almost free of pain by the end of the treatment. This indicates that PRT is effective and causes few side effects.

Another study found that two-thirds of patients treated with PRT felt pain-free or almost pain-free, compared to just 20% in a placebo group. This further demonstrates that PRT is effective and safe for many people.

While specific safety data for Brief Pain Reprocessing Therapy (BPRT) is not available, the success of PRT in other studies suggests it is a promising and safe option for managing chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Pain Reprocessing Therapy (BPRT) is unique because it focuses on retraining the brain to interpret pain differently, rather than just managing symptoms. Traditional treatments for chronic lower back pain, like medication, physical therapy, or surgery, often target the physical aspects of pain. BPRT, however, is delivered online, making it more accessible and convenient, and it emphasizes changing the emotional and cognitive responses to pain. Researchers are excited about BPRT because it offers a non-invasive, drug-free approach that could potentially provide long-term relief by addressing the psychological components of chronic pain.

What evidence suggests that Brief Pain Reprocessing Therapy might be an effective treatment for chronic lower back pain?

Research has shown that Pain Reprocessing Therapy (PRT) can significantly aid in managing long-term pain. In some studies, 66% of patients reported being pain-free or almost pain-free after treatment. Another study found that 98% of patients experienced pain improvement. This therapy helps individuals understand that pain originates in the brain, not the body, altering their perception of it. This method has demonstrated promising results in reducing pain and enhancing quality of life. ^{1 5 6 7 8}

Who Is on the Research Team?

John Sturgeon, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for Veterans experiencing chronic low back pain. Participants should be able to attend therapy sessions via Zoom and must not have conditions that would interfere with the treatment or assessment.

Inclusion Criteria

I have had low back pain for more than 6 months, frequently.

Internet access and audio-conferencing capability (e.g., Zoom meetings by phone or computer) in the home

Exclusion Criteria

Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators

Open litigation in the past 1 year, as assessed in preliminary study screening

Confirmed/suspected pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Brief Pain Reprocessing Therapy (BPRT) over the internet

8 weeks

Remote sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

21 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brief Pain Reprocessing Therapy (BPRT)

Trial Overview The study is testing Brief Pain Reprocessing Therapy (BPRT), a behavioral intervention delivered through Zoom, to see if it can help alleviate chronic low back pain in Veterans.

How Is the Trial Designed?

Group I: Brief Pain Reprocessing Therapy (BPRT) Experimental Treatment 1 Intervention

Participants will have therapy over the internet.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2784694

Effect of Pain Reprocessing Therapy vs Placebo and Usual ... Treatment response rates for 30% or greater reduction in pain, 50% or greater reduction in pain, and a pain-free or nearly pain-free state at ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8482298/

Effect of Pain Reprocessing Therapy vs Placebo and Usual ... Clinical Outcomes. Patients randomized to PRT reported substantial reductions in pain intensity at posttreatment compared with both control ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05820204

Acceptability and Efficacy of Pain Reprocessing Therapy in ... This study will compare PRT, CBT, and usual care to see which is most helpful for lowering pain and helping with other problems that people with chronic pain ...

4. news.cuanschutz.edu news.cuanschutz.edu/news-stories/new-study-provides-evidence-for-more-effective-brain-based-treatment-of-chronic-back-pain

New Study Provides Evidence for More Effective Brain ... Two-thirds of participants reported being pain-free or nearly so after reattributing pain to mind or brain processes during recovery.

5. painreprocessingtherapy.com painreprocessingtherapy.com/pain-reprocessing-therapy/

Pain Reprocessing Therapy (PRT) | Proven Chronic ... In the PRT group, 98% of patients improved and 66% of patients were pain-free or nearly pain-free at the end of treatment. These outcomes were largely ...

6. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/article-abstract/2837160

Pain Reprocessing Therapy vs Placebo and Usual Care for ... Here, we report clinical outcomes at the 5-year follow-up, testing the long-term durability of gains. What is usual care?

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07050758

NCT07050758 | Pain Reprocessing Therapy for Chronic ... A recent clinical trial indicated large effects of PRT for chronic back pain, but no studies have yet investigated PRT for CWP. Furthermore, there is little ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34586357/

Effect of Pain Reprocessing Therapy vs Placebo and Usual ... Large group differences in pain were observed at posttreatment, with a mean (SD) pain score of 1.18 (1.24) in the PRT group, 2.84 (1.64) in the ...