Pain Reprocessing Therapy for Chronic Neck and Back Pain

(ESPRIT Trial)

Overseen By Yoni Ashar, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Leg pain, Alcohol/drug misuse, Cancer, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating chronic neck and back pain using Pain Reprocessing Therapy (PRT). PRT, a type of talk therapy, helps individuals rethink their pain to reduce its impact. The therapy will occur through online group sessions, so participants need a quiet space and reliable internet. The trial seeks veterans who have experienced back pain for at least six months and can attend most sessions. It is not suitable for those with leg pain worse than back pain or who have recently undergone back surgery. As an unphased trial, this study offers veterans the chance to explore a novel therapy that could significantly enhance their quality of life.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial coordinators for more details.

What prior data suggests that Pain Reprocessing Therapy is safe for treating chronic neck and back pain?

Research has shown that Pain Reprocessing Therapy (PRT) is easy for patients to handle. In a study with 151 participants, 98% who tried PRT reported improvement. By the end of the treatment, 66% were either free of pain or nearly free of pain. This indicates that PRT is generally safe and effective for many people with long-term pain. No major side effects have been reported, offering reassurance to those considering this therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Pain Reprocessing Therapy (PRT) for chronic neck and back pain because it represents a shift from traditional pain management methods, which typically rely on medications or physical therapy. PRT focuses on retraining the brain to interpret pain signals differently, which could address pain at its root rather than just managing symptoms. This approach is particularly promising because it offers a non-invasive, drug-free alternative that could potentially reduce dependence on medications and their associated side effects. Additionally, the use of telehealth for delivering PRT sessions makes it accessible and convenient for participants, paving the way for broader accessibility and adherence.

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

Research has shown that Pain Reprocessing Therapy (PRT), which participants in this trial will receive, can effectively treat long-term pain. In one study, 98% of patients who tried PRT felt better, and 66% were either completely or almost free of pain by the end of the treatment. Another study found that, on average, people who received PRT reported significantly less pain compared to those who received a placebo or standard care. Some participants even fully recovered from their back pain after PRT sessions. These findings suggest that PRT could be a promising method for managing ongoing neck and back pain. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for veterans experiencing chronic neck or back pain. Participants should be able to attend therapy sessions via telehealth and must not have any conditions that would interfere with their ability to participate in psychological therapy.

Inclusion Criteria

I have had back pain for at least 6 months, averaging at least 4 out of 10 in intensity.

Access to safe living space, quiet room, reliable internet, and electronic device that can be used to attend telehealth therapy sessions

I can attend at least 7 out of 8 online group meetings.

Exclusion Criteria

I have a known fracture or tumor in my spine.

I have been diagnosed with severe heart disease recently.

I have trouble controlling my bowel movements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telehealth group pain reprocessing therapy once weekly

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pain Reprocessing Therapy (PRT)

Trial Overview

The study is testing Pain Reprocessing Therapy (PRT), a type of psychotherapy delivered through telehealth, designed to help patients view their chronic pain as non-threatening. There's no comparison group; all participants will receive PRT.

How Is the Trial Designed?

Group I: Pain Reprocessing Therapy Experimental Treatment 1 Intervention

Participants will participate in once weekly telehealth group pain reprocessing therapy. Sessions will last approximately 1 hour in length. Group size will be approximately 10 individuals.

Pain Reprocessing Therapy (PRT) is already approved in United States for the following indications:

Approved in United States as Pain Reprocessing Therapy for:

• Chronic back pain
• Chronic neck pain

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

VA Eastern Colorado Health Care System

Collaborator

Trials

55

Recruited

26,200+

Published Research Related to This Trial

Muscle Energy Technique (MET) has been shown to effectively reduce neck pain in patients with acute neck pain and improve cervical range of motion in those with chronic neck pain, based on a review of 21 clinical trials.

Combining MET with traditional rehabilitative approaches may enhance treatment outcomes for non-specific neck pain, although the findings should be interpreted cautiously due to methodological limitations in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Muscle Energy Technique in the Rehabilitative Treatment for Acute and Chronic Non-Specific Neck Pain: A Systematic Review. Sbardella, S., La Russa, C., Bernetti, A., et al.[2021]

Chronic low back pain is a common and costly issue, often linked to dysfunctions in the spine-supporting muscles, highlighting the need for preventive and rehabilitative treatments that focus on muscle capacity and coordination.

Medical rehabilitation therapy (MRT) is identified as one of the most effective treatments for low back pain, utilizing exercise methodology and requiring collaboration between physicians and physiotherapists to tailor treatment strategies based on individual progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical training therapy in lumbar syndromes. Broll-Zeitvogel, E., Grifka, J., Bauer, J., et al.[2019]

In a randomized controlled trial, two-thirds of participants receiving pain reprocessing therapy (PRT) reported significant relief from chronic back pain, suggesting its efficacy as a novel psychological treatment.

Qualitative interviews with 32 adults revealed that participants attributed their pain relief to mechanisms such as reappraising pain to reduce fear, understanding the emotional connections to pain, and building strong social connections with therapists and peers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I don't have chronic back pain anymore": Patient Experiences in Pain Reprocessing Therapy for Chronic Back Pain. Tankha, H., Lumley, MA., Gordon, A., et al.[2023]

Chronic low back pain is a common and costly issue, often linked to dysfunctions in the spine-supporting muscles, highlighting the need for preventive and rehabilitative treatments that focus on muscle capacity and coordination.

Medical rehabilitation therapy (MRT) is identified as one of the most effective treatments for low back pain, utilizing exercise methodology and requiring collaboration between physicians and physiotherapists to tailor treatment strategies based on individual progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Medical training therapy in lumbar syndromes]. Broll-Zeitvogel, E., Grifka, J., Bauer, J., et al.[2006]

Both high-velocity low-amplitude (HVLA) manipulation and muscle energy techniques (MET) were effective in significantly reducing pain in male workers with chronic low back pain (CLBP) over a 7-week treatment period, with improvements lasting for at least 15 days after treatment.

Despite the reduction in pain, neither technique had a significant impact on trunk neuromuscular activation or postural balance, suggesting that while pain relief is achieved, these techniques may not enhance overall trunk stability or muscle function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between high-velocity low-amplitude manipulation and muscle energy technique on pain and trunk neuromuscular postural control in male workers with chronic low back pain: A randomised crossover trial. Sturion, LA., Nowotny, AH., Barillec, F., et al.[2023]

In a review of 16 studies on chronic lower back pain, the SPRINT trial showed a significantly lower placebo response rate (19.1%) compared to other trials (38.0%), indicating that the training program implemented in SPRINT effectively reduced placebo responses.

The findings suggest that training participants and staff to accurately report pain and neutralize expectations can enhance the sensitivity of clinical trials by minimizing the placebo effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo Response Reduction and Accurate Pain Reporting Training Reduces Placebo Responses in a Clinical Trial on Chronic Low Back Pain: Results From a Comparison to the Literature. Erpelding, N., Evans, K., Lanier, RK., et al.[2022]

Platelet-rich plasma (PRP) injections have shown promise as a relatively safe treatment for degenerative disc disease in patients who have not found relief from other treatments, based on recent studies.

While PRP may provide some benefits for conditions like facet joint arthropathy, more research is needed to establish its efficacy and safety for various causes of chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma for the Treatment of Low Back Pain: a Comprehensive Review. Urits, I., Viswanath, O., Galasso, AC., et al.[2020]

Prolotherapy (PrT) using a 5% dextrose solution significantly reduced pain in patients with chronic low back pain and lumbar disc herniation, with Visual Analogue Scale (VAS) scores dropping from 7.2 before treatment to 0.9 after 52 weeks.

Out of 654 patients treated, 94.8% experienced pain improvement, indicating that PrT is a safe and effective treatment option for musculoskeletal injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified prolotherapy by 5% dextrose: Two years experiences of a traditional and complementary medicine practice center in Turkey. Solmaz, I., Orscelik, A., Koroglu, O.[2022]

In a study involving 60 participants with upper trapezius myofascial trigger points, both positional release therapy (PRT) and manual trigger point release (MTpR) improved neck range of motion and reduced pain intensity after four treatment sessions.

However, MTpR was found to be more effective than PRT, showing significant improvements in both cervical range of motion and pain levels, indicating it may be a preferred treatment option for upper trapezius muscle issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate effects of positional release therapy and manual trigger point release on neck pain and range of motion in computer users with upper trapezitis. Pathan, NM., Thakur, S., Kadam, K., et al.[2022]

Patients with persistent low back pain generally accepted physiotherapy based on Cognitive Functional Therapy (CFT), but their experiences varied widely, with some feeling abandoned due to limited access to care and social support.

Positive outcomes were linked to good collaboration with physiotherapists, understanding pain as a multidimensional issue, and developing self-management skills, highlighting the importance of a supportive healthcare environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' conceptions of undergoing physiotherapy for persistent low back pain delivered in Finnish primary healthcare by physiotherapists who had participated in brief training in cognitive functional therapy. Holopainen, R., Vuoskoski, P., Piirainen, A., et al.[2022]

Manual soft tissue therapy (MSTT) significantly reduces pain in patients with chronic neck pain, as shown in a meta-analysis of 12 randomized controlled trials involving 566 participants, with an effect size of 0.83.

The analysis suggests that while MSTT is effective, the variability in pain measurement tools used across studies may affect the results, indicating a need for more standardized clinical trials in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of manual soft tissue therapy on the pain in patients with chronic neck pain: A systematic review and meta-analysis. Wang, SQ., Jiang, AY., Gao, Q.[2022]

Breathing re-education combined with routine physical therapy significantly improved clinical outcomes for chronic neck pain in a study of 14 participants over 16 weeks, with no reported adverse events.

The study suggests that breathing re-education may be an effective treatment option for chronic neck pain, warranting further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of breathing re-education on clinical outcomes in patients with nonspecific chronic neck pain. Anwar, S., Arsalan, SA., Ahmad, A., et al.[2023]

This review analyzed 37 studies and identified a core set of patient-reported outcome measures (PROMs) for neck pain, emphasizing the Neck Disability Index and Numeric Pain Rating Scale as essential tools for assessing disability and pain intensity.

The study highlighted a significant variability in the assessment of psychosocial factors, which were the least represented in the included studies, indicating a need for further research to establish effective measures for this construct in neck pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures in physical therapy practice for neck pain: an overview of reviews. Ramirez, MM., Shepherd, MH., Melnick, SJ., et al.[2023]

In a retrospective study of 65 patients with cervical and lumbar spine pain, treatment with plasma rich in growth factors (PRGF) showed statistically significant improvements in pain and disability scores, indicating its effectiveness as a minimally invasive treatment option.

Out of 252 cases analyzed, 62% demonstrated a statistically significant improvement post-treatment, suggesting that PRGF infiltrations can be a beneficial biological strategy for managing chronic spine pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma Rich in Growth Factors (PRGF) in the Treatment of Cervical and Lumbar Back Pain: A Retrospective Observational Clinical Study. Kirchner, F., Milani, I., Martinez, A., et al.[2021]

Platelet-rich plasma (PRP) treatment significantly reduces pain in patients with chronic low back pain, as shown in a meta-analysis of three randomized controlled trials involving 138 patients.

Patients experienced substantial pain score improvements at 1, 3, and 6 months post-injection, indicating that PRP is a promising treatment option for chronic low back pain compared to control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potency of Platelet-Rich Plasma for Chronic Low Back Pain: A Systematic Review and Metaanalysis of Randomized Controlled Trial. Singjie, LC., Kusuma, SA., Saleh, I., et al.[2023]

Citations

1.

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 ...

2.

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 ...

3.

medcentral.com

medcentral.com/pain/spine/pain-reprocessing-therapy-yields-long-term-back-pain-relief

Pain Reprocessing Therapy Yields Long-Term Back ...

Some study participants reported full recovery from their back pain after PRT sessions, which are based in CBT techniques.

4.

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 ...

5.

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 ...

They found two-thirds of people treated with PRT reported being pain-free or nearly so after treatment, compared to only 20% of placebo ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11020878/

“I don't have chronic back pain anymore”: Patient experiences ...

Participants randomized to PRT experienced large reductions in pain intensity: 66% were pain-free or nearly so at post-treatment. Gains were largely maintained ...

7.

physio-pedia.com

physio-pedia.com/Pain_Reprocessing_Therapy_(PRT)

Pain Reprocessing Therapy (PRT)

Pain reprocessing therapy is aimed toward changing the way the brain reacts when faced with a chronic pain trigger. Essentially, the brain will unlearn what it ...

8.

painreprocessingtherapy.com

painreprocessingtherapy.com/news/

Pain Reprocessing Therapy in the News | Research & ...

A secondary analysis of clinical trial data shows that Pain Reprocessing Therapy significantly reduces pain intensity and fear avoidance behaviors by increasing ...