Chronic Low-back Pain (cLBP)NCT07679178
Comparing Non-Medicine Strategies for Improving Low Back Pain
A study of Chronic Low-back Pain (cLBP) and High-Impact Chronic Pain (HICP), run by Duke University at 1 site in United States.
Trial summary
The goal of this clinical trial is to help veterans manage high-impact chronic pain (HICP) in the lower back. The trial will use a program, ENCompaSS (Education, Navigated Care, and Supported Self-Management) designed to reduce pain more than usual care alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to 31 Jul 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be age 18 years old or older
- Have a VA outpatient clinic visit for low back pain within the previous 30 days
- Be enrolled in a participating primary care clinic
- Have high impact chronic pain per Graded Chronic Pain Scale (most days or every day on first 2 items)
- Valid telephone access
- Ability to provide informed consent
Who cannot join
- Are currently hospitalized or residing in a nursing home
- Have cognitive impairment or lack of decision-making capacity
- Have a serious mental illness (e.g., schizophrenia, bipolar disorder, recent psychiatric hospitalization, high risk suicide flag)
- Are unable to communicate by telephone or have no telephone access
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing Strategies to Improve Non-Pharmacologic Pain Relief for Adults With Back Pain (The ENCompaSS Trial)
The goal of this clinical trial is to help veterans manage high-impact chronic pain (HICP) in the lower back. The trial will use a program, ENCompaSS (Education, Navigated Care, and Supported Self-Management) designed to reduce pain more than usual care alone. Researchers will assess a) the impact of ENCompaSS, b) identify which veterans benefit the most, and c) how this program can be delivered more broadly in other clinics and health systems.
What Will Happen:
Read more
Veterans in this clinical trial will be randomly placed into one of two groups.
ENCompaSS group (intervention):
- Have at least three phone calls with a trained clinician over about 12 weeks
- Watch short online videos about managing pain
- Complete surveys before the study and again at 2, 4, 6, and 12 months
Usual Stepped Care group:
- Will continue with regular care
- Complete the same surveys at the same time points
Read the detailed description
ENCompaSS (Education, Navigated Care, and Supported Self-Management), is a type 1 hybrid effectiveness-implementation trial conducted within three Veterans Heath Administration (VHA) systems. The intervention is a patient-centered, navigator-assisted program designed to inform and guide Veterans on non-pharmacologic treatment options.
The total study duration, including enrollment and follow-up, is approximately 30 months. A total of 530 veterans with high-impact chronic pain (HICP) due to low back pain (LBP) will be enrolled and randomized in a 1:1 ratio to receive either the ENCompaSS intervention or usual stepped care within the VA health system. In keeping with the pragmatic design, participating VHA sites will receive standardized training and implementation support but will deliver the intervention using their existing clinical staff and resources.
Patient-reported outcomes will be collected via telephone-administered Research Electronic Data Capture (REDCap) surveys at baseline and at 2, 4, 6, and 12 months post-randomization. The primary outcome will be assessed at 6 months, with additional follow-up to evaluate longer-term effects 12 months post randomization.
- Being tested
- ENCompaSS (Education, Navigated Care, and Supported Self-Management) with VA Stepped Usual Care
- Keywords
- Veterans, Low Back Pain, Clinical Pathway, Pain Management, Non-Pharmacologic
- Medical subject headings
- Low Back Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENCompaSS (Education, Navigated Care, and Supported Self-Management) with VA Stepped Usual CareOther
The ENCompaSS pain program was designed based on the Chronic Care Model (CCM), a widely used framework for organizing care for people with chronic diseases. In this model, the care provided for low back pain (LBP) meeting criteria for high-impact chronic pain (HICP), intentionally brings together the patient, provider, and system interventions necessary to accomplish the overall goal of improving pain outcomes and related co-morbidities. Our previous experiences with navigation in a previous study were only partially represented in the CCM.
ENCompaSS employs a more comprehensive blend of CCM elements, incorporating important domains such Self-Management Support, which we posit will result in better pain interference outcomes.
| Study group | Role | What they receive |
|---|---|---|
| ENCompaSS + VA Usual Stepped Care | Active comparator | The ENCompaSS trial builds on pain navigation and management by integrating:
* Structured pain education
* Shared decision making using the OPTIONS decision aid
* Facilitated referrals to preferred non pharmacologic treatments
* Supported self-management (goal setting, problem solving, self-efficacy)
* Asynchronous educational videos and optional SMS communication
Veterans randomized to ENCompaSS receive at least three structured navigator-led phone sessions over 12 weeks, delivered by trained clinicians (e.g., nurses, physical therapists, health coaches) using existing VA resources. Receives: Other: ENCompaSS (Education, Navigated Care, and Supported Self-Management) with VA Stepped Usual Care |
| VA Usual Stepped Care | No intervention | Participants randomized to VA usual stepped care alone will receive standard pain treatment available within the Veterans Health Administration (VHA) as directed by their treating provider and guided by the Stepped Care Model for Pain Management (SCM-PM). The SCM-PM, a tiered framework implemented system-wide through VHA Directive 2009-053, begins with the least intensive and most accessible treatments, progressing to more specialized and intensive interventions as needed. Key components include initial assessment and management in primary care, with referrals to specialists in pain medicine, physical medicine, rehabilitation, and behavioral health when primary care interventions are insufficient. VA usual stepped care participants will receive study materials to orient them to their treatment arm and provide assessment at multiple time points but will not receive any specific information or intervention related to LBP other than what normally would be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain interference with normal activities as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form 8a v1.0 score
The validated PROMIS Pain Interference instrument measures the self-reported consequences of pain across aspects of life including social, cognitive, emotional, physical, and recreational activities. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. A higher score indicates greater pain interference.
Measured: From enrollment to 6 Months
Secondary outcomes (7)
Average Ratings of Self-Reported Sleep Quality
Sleep quality assessed by the PROMIS 4-item short form: The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. A higher score indicates greater sleep disturbance.
Measured: Baseline to 6 Months
Average Ratings of Self-Reported Physical Function
Physical function assessed by the PROMIS 4-item short form: The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. A higher score indicates better physical function.
Measured: Baseline to 6 Months
Average Self-Reported Pain Intensity Ratings
Pain intensity assessed by the PROMIS short form: Pain intensity is a standardized, 3-question survey used to quantify how much a patient is hurting. It evaluates three parameters: average pain in the past 7 days, worst pain in the past 7 days, and current pain. Patients receive a raw total score ranging from 3 to 15, where higher scores indicate greater pain severity.
Measured: Baseline to 6 Months
Average Self-Reported Endorsement of Depression Symptoms
Depression assessed by the PROMIS 4-item short form: The depression form measures self-reported negative mood, feelings of worthlessness, and loss of interest over the past seven days on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. A higher score indicates more depression.
Measured: Baseline to 6 Months
Average Self-Reported Endorsement of Anxiety Symptoms
Anxiety assessed by the PROMIS 4-item short form: The anxiety form measures self-reported anxiety, fear, and hyperarousal over the past seven days on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. A higher score indicates more anxiety.
Measured: Baseline to 6 Months
Number of Pain-Related Emergency Department (ED) Visits
Pain-related ED visits by the VA electronic health record (EHR): ED visits for pain measured using International Classification of Diseases coding (ICD) for VA and Non-VA visits.
Measured: 12 Months post randomization
Number of Non-Pharmacologic Pain Care Visits
Non-pharmacologic pain care visits by the VA EHR: Visits for pain with non-prescribing providers using ICD coding.
Measured: 6 Months and 12 Months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startDec 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Durham VA Medical Center, Indiana University, University of Arizona, Dallas VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Susan Hastings, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679178
- Sponsor's protocol ID
- Pro00120495
- Other IDs
- BPS-2024-40339
- Status last verified
- Nov 2026
- First submitted
- 25 Jun 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data sets will be shared a timely manner with privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website. To enable broad resource sharing, the study statistician will create de-identified, publication-specific datasets including all variables presented in the publication. The PIs hold responsibility for ensuring that the individuals cannot be re-identified. No data or code that could lead to re-identification of individuals will be released. The analytical datasets and statistical code used will be retained in accordance with VA record retention policy. If successful outcomes justify broader dissemination, we will seek to do so by placing relevant materials into the public domain.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Strategies to Improve Non-Pharmacologic Pain Relief for Adults With Back Pain (The ENCompaSS Trial)
- ClinicalTrials.gov ID
- NCT07679178
- Acronym / sponsor ID
- Pro00120495
- Keywords
- Veterans, Low Back Pain, Clinical Pathway, Pain Management, Non-Pharmacologic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Durham VA Medical Center, Indiana University, University of Arizona, Dallas VA Medical Center
- Study start
- Dec 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 1 Jul 2026 (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.
The goal of this clinical trial is to help veterans manage high-impact chronic pain (HICP) in the lower back. The trial will use a program, ENCompaSS (Education, Navigated Care, and Supported Self-Management) designed to reduce pain more than usual care alone. Researchers will assess a) the impact of ENCompaSS, b) identify which veterans benefit the most, and c) how this program can be delivered more broadly in other clinics and health systems.
What Will Happen:
Veterans in this clinical trial will be randomly placed into one of two groups.
ENCompaSS group (intervention):
- Have at least three phone calls with a trained clinician over about 12 weeks
- Watch short online videos about managing pain
- Complete surveys before the study and again at 2, 4, 6, and 12 months
Usual Stepped Care group:
- Will continue with regular care
- Complete the same surveys at the same time points
Detailed description
ENCompaSS (Education, Navigated Care, and Supported Self-Management), is a type 1 hybrid effectiveness-implementation trial conducted within three Veterans Heath Administration (VHA) systems. The intervention is a patient-centered, navigator-assisted program designed to inform and guide Veterans on non-pharmacologic treatment options.
The total study duration, including enrollment and follow-up, is approximately 30 months. A total of 530 veterans with high-impact chronic pain (HICP) due to low back pain (LBP) will be enrolled and randomized in a 1:1 ratio to receive either the ENCompaSS intervention or usual stepped care within the VA health system. In keeping with the pragmatic design, participating VHA sites will receive standardized training and implementation support but will deliver the intervention using their existing clinical staff and resources.
Patient-reported outcomes will be collected via telephone-administered Research Electronic Data Capture (REDCap) surveys at baseline and at 2, 4, 6, and 12 months post-randomization. The primary outcome will be assessed at 6 months, with additional follow-up to evaluate longer-term effects 12 months post randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENCompaSS + VA Usual Stepped Care | Active comparator | Other: ENCompaSS (Education, Navigated Care, and Supported Self-Management) with VA Stepped Usual CareThe ENCompaSS trial builds on pain navigation and management by integrating: * Structured pain education * Shared decision making using the OPTIONS decision aid * Facilitated referrals to preferred non pharmacologic treatments * Supported self-management (goal setting, problem solving, self-efficacy) * Asynchronous educational videos and optional SMS communication Veterans randomized to ENCompaSS receive at least three structured navigator-led phone sessions over 12 weeks, delivered by trained clinicians (e.g., nurses, physical therapists, health coaches) using existing VA resources. |
| VA Usual Stepped Care | No intervention | –Participants randomized to VA usual stepped care alone will receive standard pain treatment available within the Veterans Health Administration (VHA) as directed by their treating provider and guided by the Stepped Care Model for Pain Management (SCM-PM). The SCM-PM, a tiered framework implemented system-wide through VHA Directive 2009-053, begins with the least intensive and most accessible treatments, progressing to more specialized and intensive interventions as needed. Key components include initial assessment and management in primary care, with referrals to specialists in pain medicine, physical medicine, rehabilitation, and behavioral health when primary care interventions are insufficient. VA usual stepped care participants will receive study materials to orient them to their treatment arm and provide assessment at multiple time points but will not receive any specific information or intervention related to LBP other than what normally would be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be age 18 years old or older
- Have a VA outpatient clinic visit for low back pain within the previous 30 days
- Be enrolled in a participating primary care clinic
- Have high impact chronic pain per Graded Chronic Pain Scale (most days or every day on first 2 items)
- Valid telephone access
Key exclusion criteria (4 listed)
- Are currently hospitalized or residing in a nursing home
- Have cognitive impairment or lack of decision-making capacity
- Have a serious mental illness (e.g., schizophrenia, bipolar disorder, recent psychiatric hospitalization, high risk suicide flag)
- Are unable to communicate by telephone or have no telephone access
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 |
|---|---|---|
| ENCompaSS (Education, Navigated Care, and Supported Self-Management) with VA Stepped Usual CareThe ENCompaSS pain program was designed based on the Chronic Care Model (CCM), a widely used framework for organizing care for people with chronic diseases. In this model, the care provided for low back pain (LBP) meeting criteria for high-impact chronic pain (HICP), intentionally brings together the patient, provider, and system interventions necessary to accomplish the overall goal of improving pain outcomes and related co-morbidities. Our previous experiences with navigation in a previous study were only partially represented in the CCM. ENCompaSS employs a more comprehensive blend of CCM elements, incorporating important domains such Self-Management Support, which we posit will result in better pain interference outcomes. | Other | ENCompaSS + VA Usual Stepped Care |
Primary outcome
Pain interference with normal activities as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form 8a v1.0 score
Time frame: From enrollment to 6 Months
The validated PROMIS Pain Interference instrument measures the self-reported consequences of pain across aspects of life including social, cognitive, emotional, physical, and recreational activities. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. A higher score indicates greater pain interference.
7 secondary outcomes
Average Ratings of Self-Reported Sleep Quality
Time frame: Baseline to 6 Months
Average Ratings of Self-Reported Physical Function
Time frame: Baseline to 6 Months
Average Self-Reported Pain Intensity Ratings
Time frame: Baseline to 6 Months
Average Self-Reported Endorsement of Depression Symptoms
Time frame: Baseline to 6 Months
Average Self-Reported Endorsement of Anxiety Symptoms
Time frame: Baseline to 6 Months
Number of Pain-Related Emergency Department (ED) Visits
Time frame: 12 Months post randomization
Number of Non-Pharmacologic Pain Care Visits
Time frame: 6 Months and 12 Months post randomization
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 6 Nov 2026.
- Individual participant dataSharing planned: Yes. Study data sets will be shared a timely manner with privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website. To enable broad resource sharing, the study statistician will create de-identified, publication-specific datasets including all variables presented in the publication. The PIs hold responsibility for ensuring that the individuals cannot be re-identified. No data or code that could lead to re-identification of individuals will be released. The analytical datasets and statistical code used will be retained in accordance with VA record retention policy. If successful outcomes justify broader dissemination, we will seek to do so by placing relevant materials into the public domain.
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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.
Susan Hastings, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Low-back Pain (cLBP) and High-Impact Chronic Pain (HICP), run by Duke University 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 4 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: opening soon, as of the sponsor's last update on 6 Nov 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain interference with normal activities as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form 8a v1.0 score (time frame: From enrollment to 6 Months). 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 6 Nov 2026.