180 Participants Needed

Digital Therapy for Chronic Back Pain

AC
SC
Overseen BySheri Cheng
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.678910

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.58111213

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

DP

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
See 3 more

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.
See 2 more

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
3Treatment groups
Experimental Treatment
Active Control
Group I: Participants with Chronic Back Pain in Self-Guided ProgramExperimental Treatment1 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 ProgramExperimental Treatment1 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 CareActive Control1 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

Find a Clinic Near You

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.
"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.
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.
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]

References

"I don't have chronic back pain anymore": Patient Experiences in Pain Reprocessing Therapy for Chronic Back Pain. [2023]
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]
Identifying Patients With Chronic Low Back Pain Who Respond Best to Mechanical Diagnosis and Therapy: Secondary Analysis of a Randomized Controlled Trial. [2017]
Digital Therapeutic Care and Decision Support Interventions for People With Low Back Pain: Systematic Review. [2022]
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]
Using Postmarket Surveillance to Assess Safety-Related Events in a Digital Rehabilitation App (Kaia App): Observational Study. [2022]
Kinesio taping for chronic low back pain: A systematic review. [2022]
Digital Therapeutics (DTx) Expand Multimodal Treatment Options for Chronic Low Back Pain: The Nexus of Precision Medicine, Patient Education, and Public Health. [2023]
[Multimodal integrated assessment and treatment of patients with back pain. Pain related results and ability to work]. [2022]
Economic Evaluation of Digital Therapeutic Care Apps for Unsupervised Treatment of Low Back Pain: Monte Carlo Simulation. [2023]
Embodiment in Virtual Reality for the Treatment of Chronic Low Back Pain: A Case Series. [2022]
Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial. [2022]
Behavioural treatment for chronic low-back pain. [2022]
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