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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators are conducting a trial that evaluates the feasibility of telehealth group pain reprocessing therapy (PRT), with no comparison group, for the treatment of chronic back pain in a population of veterans. PRT is a psychotherapy for chronic pain that aims to help patients reconceptualize their pain as a non-dangerous signal. It has been shown to be effective in a previous RCT (n=151).

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 data supports the idea that Pain Reprocessing Therapy for Chronic Neck and Back Pain is an effective treatment?

The available research shows that Pain Reprocessing Therapy (PRT) is effective for chronic back pain. In a study, two-thirds of patients who received PRT reported that their chronic back pain was either completely gone or almost gone. This suggests that PRT can significantly reduce or eliminate pain for many people. Compared to breathing re-education for chronic neck pain, which also showed improvement, PRT has a higher reported rate of pain elimination for back pain. ^{1 2 3 4 5}

What safety data exists for Pain Reprocessing Therapy for chronic neck and back pain?

The provided research does not contain safety data for Pain Reprocessing Therapy (PRT) for chronic neck and back pain. The studies focus on platelet-rich plasma (PRP) and other regenerative treatments for low back pain, not PRT. ^{6 7 8 9 10}

Is Pain Reprocessing Therapy (PRT) a promising treatment for chronic neck and back pain?

The provided research articles do not directly discuss Pain Reprocessing Therapy (PRT) for chronic neck and back pain. However, they highlight the importance of various manual therapies and rehabilitation techniques in managing such pain. This suggests that treatments focusing on muscle and spine health, like PRT, could be promising for reducing pain and improving function. ^{11 12 13 14 15}

Eligibility Criteria

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.

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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.[2006]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

"I don't have chronic back pain anymore": Patient Experiences in Pain Reprocessing Therapy for Chronic Back Pain. [2023]

2. Pakistan pubmed.ncbi.nlm.nih.gov

Effects of breathing re-education on clinical outcomes in patients with nonspecific chronic neck pain. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures in physical therapy practice for neck pain: an overview of reviews. [2023]

4. England 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. [2022]

5. England 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. [2022]

6. United States 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. [2022]

7. United States 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. [2021]

8. Korea (South) 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma for the Treatment of Low Back Pain: a Comprehensive Review. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Modified prolotherapy by 5% dextrose: Two years experiences of a traditional and complementary medicine practice center in Turkey. [2022]

11. India 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. [2022]

12. South Africa 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. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Muscle Energy Technique in the Rehabilitative Treatment for Acute and Chronic Non-Specific Neck Pain: A Systematic Review. [2021]

14. Germany pubmed.ncbi.nlm.nih.gov

[Medical training therapy in lumbar syndromes]. [2006]

15. Germany pubmed.ncbi.nlm.nih.gov

Medical training therapy in lumbar syndromes. [2019]