Chronic Back PainNCT06641102
Healing Track Clinical Trial
A study testing Self-Guided Program (Tier 1) and Coach Assisted Program (Tier 3) in people with Chronic Back Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Chronic Back Pain
- What is being tested?
- Self-Guided Program (Tier 1) and Coach Assisted Program (Tier 3)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21 to 70
- Chronic Back Pain- CBP will be defined according to the criteria established by a recent NIH task force
- 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. That is, patients can meet criteria by either reporting pain every day for the past 3 months, or by reporting pain on half or more of the days for the past 6+ months.
- Patients must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPISF) (on the item measuring average pain over the last week).
- Participants must also be comfortable and able to communicate via email or text message, as several study measures are collected in this manner.
- Able to use a smartphone
Who cannot join
- Back pain associated with compensation or litigation issues as determined by self-report within the past year
- Leg pain is greater than back pain, as this suggests neuropathic pain, which may be less responsive to psychotherapy
- Cauda Equina syndrome, as screened for by self-reported inability to control bowel or bladder function
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai - Abilities Research Center
New York, New York, 10029
David Putrino
About this study
Official title: Healing Track Randomized Clinical 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.
Read more
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.
- Conditions
- Chronic Back Pain
- Being tested
- Self-Guided Program (Tier 1), Coach Assisted Program (Tier 3), Standard of Care (SOC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Guided Program (Tier 1)Other
The study intervention is a smartphone application.
Tier 1: self-guided program, includes videos, guided meditations, and worksheets that are delivered to users in 10 different topical modules. Two modules are delivered per week, with email reminders. It will emphasize that PRT is a practice that requires users to come back to the material regularly to help retrain the brain often (just like how you need to practice and complete exercises between PT sessions).
Coach Assisted Program (Tier 3)Other
The study intervention is a smartphone application.
Tier 3: one-on-one coaching program that sets users up with trained PRT coaches who will walk them through the program individually. Users will meet with the assigned coaches once per week for an hour-long Zoom-hosted session that covers the same information as Tier 1, however in a completely personal and individualized way, focusing on the content that is most relevant for the user/patient at the time of the session. Tier 3 users will also receive materials from their coaches (e.g. videos, meditations, etc.) to support their own practice between session.
Standard of Care (SOC)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Chronic Back Pain in Self-Guided Program | Experimental | 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. Receives: Other: Self-Guided Program (Tier 1) |
| Participants with Chronic Back Pain in Coach Assisted Program | Experimental | 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. Receives: Other: Coach Assisted Program (Tier 3) |
| Participants receiving Standard of Care | Active comparator | Standard of care (SOC) control group in adults with CBP. Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory Short Form
A 9-item instrument with total score from 0 to 10, with higher score indicating worse outcomes. Full scale from 0 to 10, with higher score indicating more pain symptoms.
Minimum score: 0 (no pain) Maximum score: 10 (pain as bad as you can imagine)
Measured: <Day 0, Day 0, Day 1, Week 6, Week 10, Month 8.5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start12 May 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Back PainStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Healing Track
- Responsible party
- Principal investigator, David Putrino, Icahn School of Medicine at Mount Sinai
- Investigators
- David Putrino, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641102
- Sponsor's protocol ID
- STUDY-24-00080
- Status last verified
- Jun 2025
- First submitted
- 11 Oct 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Track Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06641102
- Acronym / sponsor ID
- STUDY-24-00080
- Conditions
- Chronic Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Healing Track
- Study start
- 12 May 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants with Chronic Back Pain in Self-Guided Program | Experimental | Other: Self-Guided Program (Tier 1)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. |
| Participants with Chronic Back Pain in Coach Assisted Program | Experimental | Other: Coach Assisted Program (Tier 3)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. |
| Participants receiving Standard of Care | Active comparator | Other: Standard of Care (SOC)Standard of care (SOC) control group in adults with CBP. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 21 to 70
- Chronic Back Pain- CBP will be defined according to the criteria established by a recent NIH task force
- 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. That is, patients can meet criteria by either reporting pain every day for the past 3 months, or by reporting pain on half or more of the days for the past 6+ months.
- Patients must rate pain intensity at 4/10 or greater on the Brief Pain Inventory-Short Form (BPISF) (on the item measuring average pain over the last week).
- Participants must also be comfortable and able to communicate via email or text message, as several study measures are collected in this manner.
Key exclusion criteria (5 listed)
- Back pain associated with compensation or litigation issues as determined by self-report within the past year
- Leg pain is greater than back pain, as this suggests neuropathic pain, which may be less responsive to psychotherapy
- Cauda Equina syndrome, as screened for by self-reported inability to control bowel or bladder function
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Guided Program (Tier 1)The study intervention is a smartphone application. Tier 1: self-guided program, includes videos, guided meditations, and worksheets that are delivered to users in 10 different topical modules. Two modules are delivered per week, with email reminders. It will emphasize that PRT is a practice that requires users to come back to the material regularly to help retrain the brain often (just like how you need to practice and complete exercises between PT sessions). | Other | Participants with Chronic Back Pain in Self-Guided Program |
| Coach Assisted Program (Tier 3)The study intervention is a smartphone application. Tier 3: one-on-one coaching program that sets users up with trained PRT coaches who will walk them through the program individually. Users will meet with the assigned coaches once per week for an hour-long Zoom-hosted session that covers the same information as Tier 1, however in a completely personal and individualized way, focusing on the content that is most relevant for the user/patient at the time of the session. Tier 3 users will also receive materials from their coaches (e.g. videos, meditations, etc.) to support their own practice between session. | Other | Participants with Chronic Back Pain in Coach Assisted Program |
| Standard of Care (SOC)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. | Other | Participants receiving Standard of Care |
Primary outcome
Brief Pain Inventory Short Form
Time frame: <Day 0, Day 0, Day 1, Week 6, Week 10, Month 8.5
A 9-item instrument with total score from 0 to 10, with higher score indicating worse outcomes. Full scale from 0 to 10, with higher score indicating more pain symptoms. Minimum score: 0 (no pain) Maximum score: 10 (pain as bad as you can imagine)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Putrino, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Guided Program (Tier 1) and Coach Assisted Program (Tier 3) in people with Chronic Back Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Canori, DPT, PhD ((212)-241-8454, alexandra.canori@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory Short Form (time frame: <Day 0, Day 0, Day 1, Week 6, Week 10, Month 8.5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.