← Back to Search

Behavioural Intervention

Digital Therapy for Chronic Back Pain

N/A

Recruiting

Led By Laura Tabacof, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pain duration must be at least 3 months, with back pain being an ongoing problem for at least half the days of the last 6 months

Aged 21 to 70

Must not have

Cauda Equina syndrome, as screened for by self-reported inability to control bowel or bladder function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up <day 0, day 0, day 1, week 6, week 10, month 8.5

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new digital therapy for chronic back pain to see if it works as well as traditional treatments. The study will compare the pain relief effects of the digital therapy to a standard treatment plan

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-medical interventions like digital programs and coaching, there are minimal expected side effects compared to drug treatments. However, some may experience discomfort adjusting to the new therapy format.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am between 21 and 70 years old.

Select...

My average pain level over the last week is 4 out of 10 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot control my bowel or bladder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ <day 0, day 0, day 1, week 6, week 10, month 8.5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~<day 0, day 0, day 1, week 6, week 10, month 8.5

This trial's timeline: 3 weeks for screening, Varies for treatment, and <day 0, day 0, day 1, week 6, week 10, month 8.5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brief Pain Inventory Short Form

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met