Digital Therapy for Chronic Back Pain

Overseen By Sheri Cheng

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Neuropathic pain, Schizophrenia, Intravenous drugs, 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: 10

Duration: 10 weeks

180 Participants Needed

Trial Summary

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 is best to discuss this with the research team for clarification.

What data supports the effectiveness of the treatment Digital Pain Reprocessing Therapy (PRT) for chronic back pain?

In a study, two-thirds of patients who received Pain Reprocessing Therapy (PRT) reported that their chronic back pain was eliminated or nearly eliminated. This treatment helps by changing how people think about pain, reducing fear, and addressing emotions and stress. ^{1 2 3 4 5}

Is digital therapy for chronic back pain safe for humans?

There is little systematic data collected on the safety of digital therapeutics for chronic back pain, but they are generally considered safe as they are non-invasive and often involve activities like relaxation and guided breathing. ^{6 7 8 9 10}

How is Digital Pain Reprocessing Therapy different from other treatments for chronic back pain?

Digital Pain Reprocessing Therapy is unique because it uses digital technology to provide personalized, non-drug treatment for chronic back pain, focusing on changing how the brain processes pain. Unlike traditional treatments that may rely on medication or physical therapy alone, this approach integrates digital tools to enhance patient education and self-management, offering a flexible and home-based option. ^{5 8 11 12 13}

What is the purpose of this trial?

This is a randomized clinical trial to evaluate a digital pain reprocessing therapy (PRT) intervention for chronic back pain (CBP). The purpose of this research is to test whether a new digital treatment for chronic pain works as well as traditional treatments for chronic back pain (CBP). Some people with CBP experienced side effects from other treatments, or previous treatments did not relieve pain, so this research aims to see if a digital therapy is a better option for CBP. This study will assess changes in pain intensity from PRT intervention compared to a standard of care (SOC) control group in adults with CBP. SOC is defined as a comprehensive clinical care plan, including a consultation with physiatrist and prescribed interventions, which will capture a comparison representative of all potential interventions that are recommended for an individual. The research team plans to enroll 180 participants who will be randomized into one of three groups.

Research Team

David Putrino, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for adults with chronic back pain who haven't found relief from other treatments or have experienced side effects. Participants must be willing to try a digital therapy program and can follow either self-guided or coach-assisted modules, or receive standard care.

Inclusion Criteria

I have had back pain for at least 3 months, frequently in the last 6 months.

I am between 21 and 70 years old.

Able to use a smartphone

Exclusion Criteria

Self-reported diagnoses of schizophrenia, multiple personality disorder, or dissociative identity disorder

Self-reported use of intravenous drugs, due to concerns about infections and subject compliance with experimental protocols

I cannot control my bowel or bladder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a digital pain reprocessing therapy intervention or standard of care for chronic back pain

10 weeks

10 topical modules for self-guided program, regular sessions for coach-assisted program

Follow-up

Participants are monitored for changes in pain intensity and safety after treatment

6 months

Assessments at Day 0, Day 1, Week 6, Week 10, Month 8.5

Treatment Details

Interventions

• Digital Pain Reprocessing Therapy (PRT)

Trial Overview The Healing Track Clinical Trial is testing a new digital pain reprocessing therapy (PRT) against the usual treatment plans for chronic back pain. It will randomly assign participants to one of three groups: self-guided PRT, coach-assisted PRT, or standard care.

Participant Groups

Group I: Participants with Chronic Back Pain in Self-Guided Program Experimental Treatment 1 Intervention

Participants with CBP in a self-guided program that includes videos, guided meditations, and worksheets that are delivered to users in 10 different topical modules.

Group II: Participants with Chronic Back Pain in Coach Assisted Program Experimental Treatment 1 Intervention

Participants with CBP in a one-on-one coaching program that sets users up with trained PRT coaches who will walk them through the program individually.

Group III: Participants receiving Standard of Care Active Control 1 Intervention

Standard of care (SOC) control group in adults with CBP.

Digital 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

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Healing Track

Collaborator

Trials

1

Recruited

180+

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]

In a study involving 104 patients with chronic low back pain, combining spinal manipulative therapy (SMT) with pain neuroscience education (PNE) did not show immediate benefits in reducing pain intensity or disability compared to SMT alone.

However, the combination of SMT and PNE resulted in longer-lasting improvements in pain intensity and disability at 90 and 180 days, suggesting that PNE may enhance the effectiveness of SMT over time, potentially through increased pain self-efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additional effect of pain neuroscience education to spinal manipulative therapy on pain and disability for patients with chronic low back pain: a randomized controlled trial. Tavares, FAG., Rossiter, JVA., Lima, GCL., et al.[2023]

In a study of 140 patients with chronic low back pain, older individuals showed a greater reduction in pain from the Mechanical Diagnosis and Therapy (MDT) method compared to the Back School intervention, suggesting age may influence treatment effectiveness.

The findings indicate that older age could be a significant factor in determining who benefits most from MDT, but further research is needed to confirm these results due to the limitations of the study's design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Patients With Chronic Low Back Pain Who Respond Best to Mechanical Diagnosis and Therapy: Secondary Analysis of a Randomized Controlled Trial. Garcia, AN., Costa, Lda C., Hancock, M., et al.[2017]

Digital therapeutic care (DTC) programs for low back pain (LBP) have been shown to significantly reduce pain levels and improve functionality, with 67% of randomized controlled trials demonstrating these benefits compared to baseline.

Incorporating decision support interventions, such as personalized feedback and activity recommendations, enhances user engagement with DTC apps, aiding participants in self-managing their recovery effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Therapeutic Care and Decision Support Interventions for People With Low Back Pain: Systematic Review. Lewkowicz, D., Slosarek, T., Wernicke, S., et al.[2022]

A study involving 100 participants with low back pain found that a deep learning-based digital application for physical therapy (DPT) was more effective than conventional physical therapy (CPT) in improving patient satisfaction and perceived COVID-19 transmission risk.

Both DPT and CPT significantly improved back pain and functional ability, but DPT showed superior results in enhancing hip extensor strength and was more cost-effective, suggesting it could be a valuable alternative in managing low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of deep-learning digital therapeutics on pain, movement control, and preliminary cost-effectiveness in low back pain: A randomized controlled trial. Park, C., Yi, C., Choi, WJ., et al.[2023]

In a study of 138,337 users of the Kaia App for low back pain, only 0.09% reported adverse events (AEs), indicating a very low safety risk associated with this digital therapeutic.

The most common AEs were nonserious, such as increased pain and muscle issues, and older users (55 years and above) were more likely to report AEs, suggesting that age may influence the safety profile of the app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Postmarket Surveillance to Assess Safety-Related Events in a Digital Rehabilitation App (Kaia App): Observational Study. Jain, D., Norman, K., Werner, Z., et al.[2022]

A systematic review of five randomized controlled trials involving 306 subjects found that kinesio taping (KT) is not more effective than conventional physical therapy or exercise for improving pain and disability in chronic low back pain (CLBP).

However, KT may provide short-term benefits in improving range of motion and global perceived effect, suggesting it could be useful as an adjunctive therapy rather than a standalone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinesio taping for chronic low back pain: A systematic review. Nelson, NL.[2022]

Digital therapeutics (DTx), like the FDA-authorized RelieVRx virtual reality app, can effectively reduce pain severity in chronic low back pain (CLBP) patients when used alongside traditional treatments such as medications and physical therapy.

DTx provides a personalized, multimodal approach to pain management, aligning with guidelines that recommend non-pharmacological therapies as first-line treatments, and has the potential to enhance treatment outcomes while addressing the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Therapeutics (DTx) Expand Multimodal Treatment Options for Chronic Low Back Pain: The Nexus of Precision Medicine, Patient Education, and Public Health. Rohaj, A., Bulaj, G.[2023]

A study involving 394 patients with chronic back pain showed that an interdisciplinary assessment and tailored treatment options led to significant reductions in pain, anxiety, and depression after 6 months.

Patients participating in day-care pain management programs experienced the greatest improvements in wellbeing and daily activities, highlighting the effectiveness of this treatment approach for managing chronic back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Multimodal integrated assessment and treatment of patients with back pain. Pain related results and ability to work]. Marnitz, U., Weh, L., Müller, G., et al.[2022]

The digital therapeutic care (DTC) app for nonspecific low back pain showed a modest incremental cost of €135.97 and an increase of only 0.004 quality-adjusted life years (QALYs) per person per year compared to traditional physiotherapy, indicating limited efficacy.

The analysis suggests that DTC is not a dominant treatment strategy over usual care, with only a 54.96% probability of being more effective, and decision-makers should be cautious about its reimbursement due to the lack of significant treatment effects and the need for more comprehensive quality-of-life data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic Evaluation of Digital Therapeutic Care Apps for Unsupervised Treatment of Low Back Pain: Monte Carlo Simulation. Lewkowicz, D., Bottinger, E., Siegel, M.[2023]

Virtual reality-based embodiment training significantly reduced pain intensity in two patients with chronic low back pain after seven sessions, indicating its potential as an effective treatment option.

The therapy also improved psychological symptoms related to pain, such as rumination and helplessness, suggesting that virtual embodiment may help address both physical and mental aspects of chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embodiment in Virtual Reality for the Treatment of Chronic Low Back Pain: A Case Series. Trujillo, MS., Alvarez, AF., Nguyen, L., et al.[2022]

The NIH BACPAC VR trial will evaluate the effectiveness of three types of virtual reality interventions for chronic lower back pain in 360 patients over 12 weeks, focusing on skills-based, distraction-based, and sham VR programs.

The primary outcome measured will be pain interference using the PROMIS scale, along with secondary outcomes like anxiety and sleep disturbance, aiming to provide insights into non-pharmacological pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial. Birckhead, B., Eberlein, S., Alvarez, G., et al.[2022]

Moderate quality evidence suggests that operant therapy provides better short-term pain relief for chronic low-back pain (CLBP) compared to a waiting list, while behavioral therapy overall is more effective than usual care for short-term pain relief.

However, there is no significant difference in effectiveness among the various types of behavioral therapy (operant, cognitive, or combined) for pain relief in the short to intermediate term, and in the long term, behavioral therapy shows similar outcomes to group exercise for pain and depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural treatment for chronic low-back pain. Henschke, N., Ostelo, RW., van Tulder, MW., et al.[2022]

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. Brazil pubmed.ncbi.nlm.nih.gov

Additional effect of pain neuroscience education to spinal manipulative therapy on pain and disability for patients with chronic low back pain: a randomized controlled trial. [2023]

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

Identifying Patients With Chronic Low Back Pain Who Respond Best to Mechanical Diagnosis and Therapy: Secondary Analysis of a Randomized Controlled Trial. [2017]

4. Canada pubmed.ncbi.nlm.nih.gov

Digital Therapeutic Care and Decision Support Interventions for People With Low Back Pain: Systematic Review. [2022]

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

Long-term effects of deep-learning digital therapeutics on pain, movement control, and preliminary cost-effectiveness in low back pain: A randomized controlled trial. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Using Postmarket Surveillance to Assess Safety-Related Events in a Digital Rehabilitation App (Kaia App): Observational Study. [2022]

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

Kinesio taping for chronic low back pain: A systematic review. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Therapeutics (DTx) Expand Multimodal Treatment Options for Chronic Low Back Pain: The Nexus of Precision Medicine, Patient Education, and Public Health. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

[Multimodal integrated assessment and treatment of patients with back pain. Pain related results and ability to work]. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Economic Evaluation of Digital Therapeutic Care Apps for Unsupervised Treatment of Low Back Pain: Monte Carlo Simulation. [2023]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Embodiment in Virtual Reality for the Treatment of Chronic Low Back Pain: A Case Series. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Behavioural treatment for chronic low-back pain. [2022]