Pain, BackIMPACt-LBPNCT05626049
Implementation of the ACP Guideline for Low Back Pain (IMPACt-LBP)
A study testing Primary Spine Provider Model in people with Pain, Back, run by Duke University at 3 sites in United States.
Trial summary
The purpose of this study is to assess whether the primary spine practitioner (PSP) model of care will lead to improvements in patient outcomes, as compared to usual care, based on change in patient-reported PROMIS Pain Interference and Physical Function from baseline to 3 months in patients aged 18 years and older… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Back
- What is being tested?
- Primary Spine Provider Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Mar 2023to 17 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- aged 18 years and older
- initiating an outpatient visit for LBP at a participating PCP clinic
- agree to participate and complete baseline questionnaire (in lieu of formal written documentation of consent)
Who cannot join
- inability to provide consent or complete outcome questionnaires
- positive screening for cauda equina symptoms (loss of total control of bowel/bladder associated with this episode of LBP )
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke Health
Durham, North Carolina, 27713
University of Iowa
Iowa City, Iowa, 52242
Dartmouth Health
Lebanon, New Hampshire, 03755
About this study
Official title: Implementation of the American College of Physicians Guideline for Low Back Pain: A Cluster Randomized Trial (IMPACt-LBP)
The purpose of this study is to assess whether the primary spine practitioner (PSP) model of care will lead to improvements in patient outcomes, as compared to usual care, based on change in patient-reported PROMIS Pain Interference and Physical Function from baseline to 3 months in patients aged 18 years and older with a primary complaint of low back pain (LBP).
Read the detailed description
This study is a pragmatic, multi-site, two-arm cluster-randomized trial with the unit of randomization at the primary care clinic level. The overall goal is to evaluate implementation of the American College of Physicians (ACP) guideline for LBP by assessing the comparative effectiveness of the PSP model, which involves first contact care for LBP patients from either a physical therapist (PT) or a doctor of chiropractic (DC), versus usual care, which involves first contact care with primary care physicians. The study includes patients aged 18 years and older with a chief complaint of LBP.
Co-primary endpoints to be assessed are changes in Patient- Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Physical Function from baseline to 3 months. The Investigators have chosen to use these co-primary endpoints as they represent two domains that are important factors related to patient improvement.
Secondary endpoints collected at baseline, 3, 6 and 12 months include Pain Catastrophizing Scale - 4-item short form, PROMIS Global-10 (v1.2), opioid use, imaging and diagnostic testing, provider visits, and LBP-associated procedures and treatments: surgical procedures, medication prescriptions, hospital admissions and emergency room visits.
Additional exploratory analyses among enrolled patients will assess whether the PSP model leads to 1) long-term improvement compared to usual care using the PROMIS Pain Interference and Physical Function at 6, 12, and 24 months; and 2) lower healthcare utilization and costs for LBP at 12 and 24 months.
Patients enrolled within the first 12 months of the data collection phase will be included in the 24-month exploratory analyses. Additional analyses will evaluate LBP-related utilization within the academic healthcare systems among all patients seen in intervention versus control primary care clinics utilizing de-identified clinic level data extracted from the EHR.
A total of approximately 1,800 patients who seek care at a participating primary care clinic with a complaint of LBP and meet study eligibility criteria will be enrolled.
- Conditions
- Pain, Back
- Being tested
- Primary Spine Provider Model, Usual Care
- Keywords
- pain, back pain, low back pain, primary spine provider
- Medical subject headings
- Back Pain, Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Spine Provider ModelOther
Also called PSP Model
Patients with LBP seeking care at intervention clinics will be offered an appointment with a DC or PT at the initial point of contact.
Usual CareOther
Patients in this arm will receive usual care (no change to medical care).Usual care is defined as any care designated by a primary care physician (PCP).
| Study group | Role | What they receive |
|---|---|---|
| Usual Medical Care | Active comparator | This group will consist of patients who contact clinics that have been randomized to usual medical care (no change to medical care).Usual care is defined as any care designated by a primary care physician (PCP). Receives: Other: Usual Care |
| Primary Spine Provider Model | Experimental | This group will consist of patients who contact clinics that have been randomized to the primary spine provider (PSP) model (intervention clinics). Patients seeking care at intervention clinics will be given the option of seeing either a DC or a PT as their first contact clinician for an initial trial of PSP care. Receives: Other: Primary Spine Provider Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
The Investigators will compare the change in PROMIS Pain Interference scores, individually, from baseline to 3- month follow-up between usual care and intervention arms.
Measured: Baseline, 3 Months
Change in Physical Function as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
The Investigators will compare the change in PROMIS Physical Function scores, individually, from baseline to 3- month follow-up between usual care and intervention arms.
Measured: Baseline, 3 Months
Secondary outcomes (14)
NIH Low Back Pain Questions
The NIH LBP questions consist of 2-items that were developed by the NIH Task Force and are used determined patients' chronicity with LBP
Measured: Baseline, 12 Months
Patient Satisfaction
The Investigators will assess patient satisfaction with care using a single item used in prior spine studies including SPORT: "Overall, how satisfied are you with the care you received for your back pain? Very satisfied, Somewhat satisfied, Neutral, Somewhat dissatisfied, Very dissatisfied.
Measured: 3 Months
Perceived Improvement
The Investigators will measure global improvement using a one-item scale that has been used in prior pragmatic trials of low back pain: "Compared to your first visit, your low back pain is much worse, a little worse, about the same, a little better, moderately better, much better or completely gone.
Measured: 3 Months
Patient Experience
The Investigators will compare patient experience with the clinical care between groups at 3 months using a modified satisfaction with outpatient physiotherapy instrument. Domains compared will include expectations, clinician, communication, health organization, and treatment satisfaction. Physiotherapy outpatient satisfaction questionnaire (modified), score range: 32 to 160. Higher score indicates a better outcome.
Measured: 3 Months
Total Prescribed Opioid Dosage
The Investigators will compare total opioid dosage (morphine equivalents) in the 12 months after baseline. In order to be able to compare opioid doses across classes, the Investigators will use a standard formula to calculate morphine equivalents from the CDC Morphine Equivalent Factors. Within 12 months after baseline, the Investigators will determine morphine equivalent dose.
Measured: Baseline, 3 Months, 6 Months, 12 Months
PROMIS Global 10 (v1.2) - Physical Health
The PROMIS Global-10 is a 10 item PRO questionnaire which has response options presented as 5-point rating scales; Results are used to calculate a global physical health score and global mental health score with higher scores indicating better health.Patient Reported Outcomes Measurement Information System Global Health Short Form Range: 0 - 100
Measured: Baseline, 3 Months, 6 Months, 12 Months
PROMIS Global 10 (v1.2) - Mental Health
The PROMIS Global-10 is a 10 item PRO questionnaire which has response options presented as 5-point rating scales; Results are used to calculate a global physical health score and global mental health score with higher scores indicating better health.Patient Reported Outcomes Measurement Information System Global Health Short Form Range: 0 - 100
Measured: Baseline, 3 Months, 6 Months, 12 Months
Number of LBP-related Imaging and Diagnostic Tests
The Investigators will collect any imaging and diagnostic tests from the time from enrollment through 12 months or study end. These measures will be extracted from the electronic health record using ICD and CPT codes. The imaging and diagnostics include magnetic resonance imaging, computed tomography, plain film x-rays, discography, electromyography, and nerve conduction studies.
Measured: Up to approximately 12 Months
Number of LBP-related Injection Procedures
The Investigators will collect any LBP-related injection procedures conducted from the time from enrollment until 12 months or study end. These procedures will be extracted by the electronic health record using ICD and CPT codes. The injection procedure types include fascia, facet joint, intervertebral disc, and muscle.
Measured: Up to approximately 12 Months
Number of LBP-related Surgical Procedures
The Investigators will collect any LBP-related surgical procedures conducted from the time from enrollment until 12 months or study end. These surgical procedures will be extracted by the electronic health record using ICD and CPT codes. The surgical procedure types include discectomy, fusion, and decompression.
Measured: Up to approximately 12 Months
Number of LBP-related Medical Prescriptions
The Investigators will collect any LBP-related medication prescriptions from the time from enrollment until 12 months or study end. These medication prescriptions will be extracted from the electronic health record using commonly used codes during routine clinical practice. The medication types include opioids, NSAIDS, muscle relaxers, anticonvulsants, and SNRIs.
Measured: Up to approximately 12 Months
Number of LBP-related Provider Visits
The Investigators will collect any provider visits from the time from enrollment until 12 months or study end. These visits will be extracted by the electronic health record using ICD and CPT codes
Measured: Up to approximately 12 Months
Number of Hospital Admissions
The Investigators will collect any hospital admissions from the time from enrollment through 12 months or study end. These admissions will be extracted by the electronic health record using ICD and CPT codes. The admission types include routine, emergency, and elective.
Measured: Up to approximately 12 Months
Number of Emergency Room Visits
The Investigators will collect any emergency room visits from the time from enrollment until 12 months or study end. These visits will be extracted by the electronic health record using ICD and CPT codes.
Measured: Up to approximately 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start14 Mar 2023
- Primary completion17 Oct 2025
- Study completion17 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, BackStudies 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
- Model description
- Primary care clinics across three academic HCS will be allocated 1:1 to each arm (PSP model versus usual care) of the study. Clinics randomized to provide the PSP model will provide patient information regarding the ACP guideline for LBP and an LBP scheduling assistant will help patients make an appointment with either a DC or PT at the initial point of contact.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center, University of Iowa, Duke Health, Palmer College of Chiropractic, National Center for Complementary and Integrative Health (NCCIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Christine Goertz, PhD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626049
- Sponsor's protocol ID
- Pro00109780
- Acronym
- IMPACt-LBP
- Status last verified
- Oct 2026
- First submitted
- 15 Nov 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In collaboration with the NCCIH, the Investigators will develop a process to facilitate access to study data and will follow the Department of Health and Human Services guidance regarding HIPAA-compliant data sharing. Access to the limited dataset (Enrolled Cohort) will require a Data Use Agreement and IRB approval. This is a custom dataset created to include just the subset of data needed. Access to the de-identified dataset (Longitudinal Cohort) does not require a Data Use Agreement or IRB approval and is not subject to HIPAA's minimum necessary standards.
Publications
Goode AP, Goertz C, Chakraborty H, Salsbury SA, Broderick S, Levy BT, Ryan K, Settles S, Hort S, Dolor RJ, Chrischilles EA, Kasper S, Stahl JE, Almond C, Reed SD, Shannon Z, Harris D, Daly J, Winokur P, Lurie JD. Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trial. BMJ Open. 2025 Mar 26;15(3):e097133. doi: 10.1136/bmjopen-2024-097133.
PubMed 40139699
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the American College of Physicians Guideline for Low Back Pain: A Cluster Randomized Trial (IMPACt-LBP)
- ClinicalTrials.gov ID
- NCT05626049
- Acronym / sponsor ID
- IMPACt-LBP / Pro00109780
- Conditions
- Pain, Back
- Keywords
- pain, back pain, low back pain, primary spine provider
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center, University of Iowa, Duke Health, Palmer College of Chiropractic, National Center for Complementary and Integrative Health (NCCIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 23 Nov 2022 (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 purpose of this study is to assess whether the primary spine practitioner (PSP) model of care will lead to improvements in patient outcomes, as compared to usual care, based on change in patient-reported PROMIS Pain Interference and Physical Function from baseline to 3 months in patients aged 18 years and older with a primary complaint of low back pain (LBP).
Detailed description
This study is a pragmatic, multi-site, two-arm cluster-randomized trial with the unit of randomization at the primary care clinic level. The overall goal is to evaluate implementation of the American College of Physicians (ACP) guideline for LBP by assessing the comparative effectiveness of the PSP model, which involves first contact care for LBP patients from either a physical therapist (PT) or a doctor of chiropractic (DC), versus usual care, which involves first contact care with primary care physicians. The study includes patients aged 18 years and older with a chief complaint of LBP.
Co-primary endpoints to be assessed are changes in Patient- Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Physical Function from baseline to 3 months. The Investigators have chosen to use these co-primary endpoints as they represent two domains that are important factors related to patient improvement.
Secondary endpoints collected at baseline, 3, 6 and 12 months include Pain Catastrophizing Scale - 4-item short form, PROMIS Global-10 (v1.2), opioid use, imaging and diagnostic testing, provider visits, and LBP-associated procedures and treatments: surgical procedures, medication prescriptions, hospital admissions and emergency room visits.
Additional exploratory analyses among enrolled patients will assess whether the PSP model leads to 1) long-term improvement compared to usual care using the PROMIS Pain Interference and Physical Function at 6, 12, and 24 months; and 2) lower healthcare utilization and costs for LBP at 12 and 24 months.
Patients enrolled within the first 12 months of the data collection phase will be included in the 24-month exploratory analyses. Additional analyses will evaluate LBP-related utilization within the academic healthcare systems among all patients seen in intervention versus control primary care clinics utilizing de-identified clinic level data extracted from the EHR.
A total of approximately 1,800 patients who seek care at a participating primary care clinic with a complaint of LBP and meet study eligibility criteria will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Primary care clinics across three academic HCS will be allocated 1:1 to each arm (PSP model versus usual care) of the study. Clinics randomized to provide the PSP model will provide patient information regarding the ACP guideline for LBP and an LBP scheduling assistant will help patients make an appointment with either a DC or PT at the initial point of contact.
| Arm | Type | Receives |
|---|---|---|
| Usual Medical Care | Active comparator | Other: Usual CareThis group will consist of patients who contact clinics that have been randomized to usual medical care (no change to medical care).Usual care is defined as any care designated by a primary care physician (PCP). |
| Primary Spine Provider Model | Experimental | Other: Primary Spine Provider ModelThis group will consist of patients who contact clinics that have been randomized to the primary spine provider (PSP) model (intervention clinics). Patients seeking care at intervention clinics will be given the option of seeing either a DC or a PT as their first contact clinician for an initial trial of PSP care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 years and older
- initiating an outpatient visit for LBP at a participating PCP clinic
- agree to participate and complete baseline questionnaire (in lieu of formal written documentation of consent)
Key exclusion criteria (2 listed)
- inability to provide consent or complete outcome questionnaires
- positive screening for cauda equina symptoms (loss of total control of bowel/bladder associated with this episode of LBP )
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 |
|---|---|---|
| Primary Spine Provider ModelAlso: PSP ModelPatients with LBP seeking care at intervention clinics will be offered an appointment with a DC or PT at the initial point of contact. | Other | Primary Spine Provider Model |
| Usual CarePatients in this arm will receive usual care (no change to medical care).Usual care is defined as any care designated by a primary care physician (PCP). | Other | Usual Medical Care |
Primary outcome
Change in Pain Interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: Baseline, 3 Months
The Investigators will compare the change in PROMIS Pain Interference scores, individually, from baseline to 3- month follow-up between usual care and intervention arms.
Change in Physical Function as measured by PROMIS (Patient-Reported Outcomes Measurement Information System)
Time frame: Baseline, 3 Months
The Investigators will compare the change in PROMIS Physical Function scores, individually, from baseline to 3- month follow-up between usual care and intervention arms.
14 secondary outcomes
NIH Low Back Pain Questions
Time frame: Baseline, 12 Months
Patient Satisfaction
Time frame: 3 Months
Perceived Improvement
Time frame: 3 Months
Patient Experience
Time frame: 3 Months
Total Prescribed Opioid Dosage
Time frame: Baseline, 3 Months, 6 Months, 12 Months
PROMIS Global 10 (v1.2) - Physical Health
Time frame: Baseline, 3 Months, 6 Months, 12 Months
PROMIS Global 10 (v1.2) - Mental Health
Time frame: Baseline, 3 Months, 6 Months, 12 Months
Number of LBP-related Imaging and Diagnostic Tests
Time frame: Up to approximately 12 Months
Number of LBP-related Injection Procedures
Time frame: Up to approximately 12 Months
Number of LBP-related Surgical Procedures
Time frame: Up to approximately 12 Months
Number of LBP-related Medical Prescriptions
Time frame: Up to approximately 12 Months
Number of LBP-related Provider Visits
Time frame: Up to approximately 12 Months
Number of Hospital Admissions
Time frame: Up to approximately 12 Months
Number of Emergency Room Visits
Time frame: Up to approximately 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 40139699Goode AP, Goertz C, Chakraborty H, Salsbury SA, Broderick S, Levy BT, Ryan K, Settles S, Hort S, Dolor RJ, Chrischilles EA, Kasper S, Stahl JE, Almond C, Reed SD, Shannon Z, Harris D, Daly J, Winokur P, Lurie JD. Implementation of the American- College of Physicians Guideline for Low Back Pain (IMPACt-LBP): protocol for a healthcare systems embedded multisite pragmatic cluster-randomised trial. BMJ Open. 2025 Mar 26;15(3):e097133. doi: 10.1136/bmjopen-2024-097133.
- Individual participant dataSharing planned: Yes. In collaboration with the NCCIH, the Investigators will develop a process to facilitate access to study data and will follow the Department of Health and Human Services guidance regarding HIPAA-compliant data sharing. Access to the limited dataset (Enrolled Cohort) will require a Data Use Agreement and IRB approval. This is a custom dataset created to include just the subset of data needed. Access to the de-identified dataset (Longitudinal Cohort) does not require a Data Use Agreement or IRB approval and is not subject to HIPAA's minimum necessary standards.
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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. This study is not recruiting at the moment.
Christine Goertz, PhD principal investigator
Duke Clinical Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Spine Provider Model in people with Pain, Back, run by Duke University at 3 sites 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Pain Interference as measured by PROMIS (Patient-Reported Outcomes Measurement Information System) (time frame: Baseline, 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05626049, which also lists 1 linked publication.
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 13 Oct 2026.