Low Back PainAIM-BACKNCT04411420
Improving Veteran Access to Integrated Management of Back Pain
A study testing Pain modulation with physical pain treatment, Telephone delivered self-management counseling for increasing physical activity and Telephone delivered behavioral treatment for participants with high risk for continued disability in people with Low Back Pain and Veterans Family, run by Duke University at 1 site in United States.
Trial summary
The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Veterans Family
- What is being tested?
- Pain modulation with physical pain treatment, Telephone delivered self-management counseling for increasing physical activity and Telephone delivered behavioral treatment for participants with high risk for continued disability
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,817 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age >= 18
- Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic
- Provider determines LBP is appropriate for conservative management
- Referred to integrated ICP pathway or CCP pathway by participating clinic provider
Who cannot join
- Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults)
- No documented phone number in the electronic health record.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial
The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.
- Conditions
- Low Back Pain, Veterans Family
- Being tested
- Pain modulation with physical pain treatment, Telephone delivered self-management counseling for increasing physical activity, Telephone delivered behavioral treatment for participants with high risk for continued disability, Patient preference treatment protocol, Nonpharmacological guideline adherent treatment protocol
- Keywords
- clinical pathway, veterans, low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain modulation with physical pain treatmentBehavioural
Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation
Telephone delivered self-management counseling for increasing physical activityBehavioural
Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient
Telephone delivered behavioral treatment for participants with high risk for continued disabilityBehavioural
Patients with a higher risk of developing chronic or persistent back pain will be identified using the nine question risk stratification start back screening tool (SBST) and will receive six additional weeks of physical activity instructions and additional pain modulation treatments as needed.
Patient preference treatment protocolBehavioural
the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol
Nonpharmacological guideline adherent treatment protocolBehavioural
the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient
Facilitated referrals to existing VA or non-VA pain management resourcesBehavioural
the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Care Pathway | Active comparator | The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA. Receives: Behavioral: Pain modulation with physical pain treatment; Behavioral: Telephone delivered self-management counseling for increasing physical activity; Behavioral: Telephone delivered behavioral treatment for participants with high risk for continued disability |
| Coordinated Care Management Pathway | Active comparator | The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain. Receives: Behavioral: Patient preference treatment protocol; Behavioral: Nonpharmacological guideline adherent treatment protocol; Behavioral: Facilitated referrals to existing VA or non-VA pain management resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Interference Measure
The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure pain interference. 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. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater pain interference.
Measured: Baseline, three months post baseline
Change in Physical Function Measure
The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure physical function. 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. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates better physical function.
Measured: Baseline, three months post baseline
Secondary outcomes (6)
Change in Sleep Disturbance
The PROMIS Short form scores will be collected in the medical record by the provider at baseline, and three months post baseline to measure sleep disturbance. 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. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater sleep disturbance.
Measured: Baseline, three months post baseline
Change in Patient Reported Outcomes--PROMIS Sleep Disturbance
The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure sleep disturbance. 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. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates greater sleep disturbance.
Measured: Baseline, three, six, and twelve months
Number of Participants With Opioid Use--Chronic User
Opioid use will be defined at baseline and 12 months post baseline as a binary variable based on whether a chronic opioid user or not at baseline and at twelve months. Opioid use is chronic if participant had at least one prescription with a total day supply of at least 120 days or if there were at least 10 prescription fills in the 12 months prior to the specified timepoint (baseline, 12 months post baseline).
Measured: Baseline, twelve months post baseline
Change in Opioid Use - Morphine Dose
Opioid use--morphine dose will be defined at baseline and 12 months post baseline as a continuous variable measuring morphine equivalents for opioid dose at baseline and twelve months. Change in total milligrams of morphine equivalents (MME) use is reported.
Measured: Baseline, twelve months post baseline
Change in Patient Reported Outcomes--PROMIS Pain Interference
The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain interference. 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. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates greater pain interference.
Measured: Baseline, three, six, and twelve months
Change in Patient Reported Outcomes--PROMIS Physical Function
The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure physical function. The physical function form asks the participant to rate a series of physical function 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. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates better physical function.
Measured: Baseline, three, six, and twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start8 Mar 2021
- Primary completion13 May 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- This study is a 4-year cluster randomized pragmatic trial comparing the effectiveness of a sequenced, multi-modal integrated care pathway for lower back pain (LBP) to a care management by pain navigator program for LBP. The study target population is veterans seeking services for lower back pain in participating VA clinics. We plan to enroll 16 VA clinics randomized in a 1:1 Ratio using a covariate constrained randomization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,817 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Durham VA Medical Center, University of North Carolina, Chapel Hill, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Susan N Hastings, MD, Principal investigator, Duke University / Durham VASteven Z George, PT, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411420
- Sponsor's protocol ID
- Pro00101938
- Other IDs
- UH3AT009790
- Acronym
- AIM-BACK
- Status last verified
- Jun 2025
- First submitted
- 27 May 2020
- Last updated
- 27 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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. Study manuals and clinical tools will be shared with the NIH PMC3 Collaboratory and VA health care system facilities. If successful outcomes justify broader dissemination, we will seek to do so by placing relevant materials into the public domain.
Publications
George SZ, Coffman CJ, Allen KD, Lentz TA, Choate A, Goode AP, Simon CB, Grubber JM, King H, Cook CE, Keefe FJ, Ballengee LA, Naylor J, Brothers JL, Stanwyck C, Alkon A, Hastings SN. Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial. Pain Med. 2020 Dec 12;21(Suppl 2):S62-S72. doi: 10.1093/pm/pnaa348.
PubMed 33313728Lentz TA, Coffman CJ, Cope T, Stearns Z, Simon CB, Choate A, Gladney M, France C, Hastings SN, George SZ. If You Build It, Will They Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain. Phys Ther. 2024 Feb 1;104(2):pzad127. doi: 10.1093/ptj/pzad127.
PubMed 37756618Ballengee LA, King HA, Simon C, Lentz TA, Allen KD, Stanwyck C, Gladney M, George SZ, Hastings SN. Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial. Clin Trials. 2023 Oct;20(5):463-472. doi: 10.1177/17407745231178789. Epub 2023 Jun 2.
PubMed 37269070Ballengee LA, Lentz TA, Check D, Zullig LL, Hastings SN, North R, King HA, Lynch C, George SZ. Clinically relevant contextual factors for enrolling patients in a pain intervention across multiple health care centers. Implement Sci Commun. 2026 May 5;7(1):122. doi: 10.1186/s43058-026-00943-w.
PubMed 42083042George SZ, France C, Coffman CJ, Allen KD, Lentz TA, North R, Choate A, Goode AP, Simon CB, Grubber JM, King H, Cook CE, Keefe FJ, Ballengee LA, Naylor J, Brothers JL, Stanwyck C, Linton T, Tumminello C, Hastings SN. Baseline characteristics of Veterans from improving Veteran access to integrated management of back pain (AIM-Back) - an embedded pragmatic, cluster-randomized trial in the United States. Pain Manag. 2026 Jun;16(6):615-623. doi: 10.1080/17581869.2026.2652307. Epub 2026 Apr 7.
PubMed 41944169George SZ, Coffman CJ, North R, Lentz TA, France C, Choate A, Simon CB, Cook CE, Keefe FJ, Allen KD, Goode AP, King H, Naylor J, Ballengee LA, Cope TL, Brothers JL, Guzman I, Linton T, Stanwyck C, Tumminello C, Hastings SN. Sequenced Care Pathway vs Pain Navigator Pathway for Veterans With Low Back Pain: The AIM-Back Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e264421. doi: 10.1001/jamanetworkopen.2026.4421.
PubMed 41926124George SZ, France C, Coffman CJ, Allen KD, Lentz TA, North R, Choate A, Goode AP, Simon CB, Grubber JM, King H, Cook CE, Keefe FJ, Ballengee LA, Naylor J, Brothers JL, Stanwyck C, Linton T, Tumminello C, Hastings SN. Cohort Profile: Baseline Characteristics of Veterans from Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) - an Embedded Pragmatic, Cluster Randomized Trial in the United States. medRxiv [Preprint]. 2024 Nov 26:2024.11.23.24317833. doi: 10.1101/2024.11.23.24317833.
PubMed 39649618
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT04411420
- Acronym / sponsor ID
- AIM-BACK / Pro00101938
- Conditions
- Low Back Pain, Veterans Family
- Keywords
- clinical pathway, veterans, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,817 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Durham VA Medical Center, University of North Carolina, Chapel Hill, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Posted 27 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a 4-year cluster randomized pragmatic trial comparing the effectiveness of a sequenced, multi-modal integrated care pathway for lower back pain (LBP) to a care management by pain navigator program for LBP. The study target population is veterans seeking services for lower back pain in participating VA clinics. We plan to enroll 16 VA clinics randomized in a 1:1 Ratio using a covariate constrained randomization.
| Arm | Type | Receives |
|---|---|---|
| Integrated Care Pathway | Active comparator | Behavioral: Pain modulation with physical pain treatment, Behavioral: Telephone delivered self-management counseling for increasing physical activity, Behavioral: Telephone delivered behavioral treatment for participants with high risk for continued disabilityThe integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA. |
| Coordinated Care Management Pathway | Active comparator | Behavioral: Patient preference treatment protocol, Behavioral: Nonpharmacological guideline adherent treatment protocol, Behavioral: Facilitated referrals to existing VA or non-VA pain management resourcesThe care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 18
- Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic
- Provider determines LBP is appropriate for conservative management
- Referred to integrated ICP pathway or CCP pathway by participating clinic provider
Key exclusion criteria (2 listed)
- Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults)
- No documented phone number in the electronic health record.
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 |
|---|---|---|
| Pain modulation with physical pain treatmentExamples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation | Behavioural | Integrated Care Pathway |
| Telephone delivered self-management counseling for increasing physical activityCentrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient | Behavioural | Integrated Care Pathway |
| Telephone delivered behavioral treatment for participants with high risk for continued disabilityPatients with a higher risk of developing chronic or persistent back pain will be identified using the nine question risk stratification start back screening tool (SBST) and will receive six additional weeks of physical activity instructions and additional pain modulation treatments as needed. | Behavioural | Integrated Care Pathway |
| Patient preference treatment protocolthe pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol | Behavioural | Coordinated Care Management Pathway |
| Nonpharmacological guideline adherent treatment protocolthe pain navigator will select only nonpharmacological guideline adherent treatment options for the patient | Behavioural | Coordinated Care Management Pathway |
| Facilitated referrals to existing VA or non-VA pain management resourcesthe pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient. | Behavioural | Coordinated Care Management Pathway |
Primary outcome
Change in Pain Interference Measure
Time frame: Baseline, three months post baseline
The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure pain interference. 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. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater pain interference.
Change in Physical Function Measure
Time frame: Baseline, three months post baseline
The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure physical function. 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. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates better physical function.
6 secondary outcomes
Change in Sleep Disturbance
Time frame: Baseline, three months post baseline
Change in Patient Reported Outcomes--PROMIS Sleep Disturbance
Time frame: Baseline, three, six, and twelve months
Number of Participants With Opioid Use--Chronic User
Time frame: Baseline, twelve months post baseline
Change in Opioid Use - Morphine Dose
Time frame: Baseline, twelve months post baseline
Change in Patient Reported Outcomes--PROMIS Pain Interference
Time frame: Baseline, three, six, and twelve months
Change in Patient Reported Outcomes--PROMIS Physical Function
Time frame: Baseline, three, six, and twelve months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33313728George SZ, Coffman CJ, Allen KD, Lentz TA, Choate A, Goode AP, Simon CB, Grubber JM, King H, Cook CE, Keefe FJ, Ballengee LA, Naylor J, Brothers JL, Stanwyck C, Alkon A, Hastings SN. Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial. Pain Med. 2020 Dec 12;21(Suppl 2):S62-S72. doi: 10.1093/pm/pnaa348.
- Background: PubMed 37756618Lentz TA, Coffman CJ, Cope T, Stearns Z, Simon CB, Choate A, Gladney M, France C, Hastings SN, George SZ. If You Build It, Will They Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain. Phys Ther. 2024 Feb 1;104(2):pzad127. doi: 10.1093/ptj/pzad127.
- Background: PubMed 37269070Ballengee LA, King HA, Simon C, Lentz TA, Allen KD, Stanwyck C, Gladney M, George SZ, Hastings SN. Partner engagement for planning and development of non-pharmacological care pathways in the AIM-Back trial. Clin Trials. 2023 Oct;20(5):463-472. doi: 10.1177/17407745231178789. Epub 2023 Jun 2.
- Derived from this study: PubMed 42083042Ballengee LA, Lentz TA, Check D, Zullig LL, Hastings SN, North R, King HA, Lynch C, George SZ. Clinically relevant contextual factors for enrolling patients in a pain intervention across multiple health care centers. Implement Sci Commun. 2026 May 5;7(1):122. doi: 10.1186/s43058-026-00943-w.
- Derived from this study: PubMed 41944169George SZ, France C, Coffman CJ, Allen KD, Lentz TA, North R, Choate A, Goode AP, Simon CB, Grubber JM, King H, Cook CE, Keefe FJ, Ballengee LA, Naylor J, Brothers JL, Stanwyck C, Linton T, Tumminello C, Hastings SN. Baseline characteristics of Veterans from improving Veteran access to integrated management of back pain (AIM-Back) - an embedded pragmatic, cluster-randomized trial in the United States. Pain Manag. 2026 Jun;16(6):615-623. doi: 10.1080/17581869.2026.2652307. Epub 2026 Apr 7.
- Derived from this study: PubMed 41926124George SZ, Coffman CJ, North R, Lentz TA, France C, Choate A, Simon CB, Cook CE, Keefe FJ, Allen KD, Goode AP, King H, Naylor J, Ballengee LA, Cope TL, Brothers JL, Guzman I, Linton T, Stanwyck C, Tumminello C, Hastings SN. Sequenced Care Pathway vs Pain Navigator Pathway for Veterans With Low Back Pain: The AIM-Back Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e264421. doi: 10.1001/jamanetworkopen.2026.4421.
- Derived from this study: PubMed 39649618George SZ, France C, Coffman CJ, Allen KD, Lentz TA, North R, Choate A, Goode AP, Simon CB, Grubber JM, King H, Cook CE, Keefe FJ, Ballengee LA, Naylor J, Brothers JL, Stanwyck C, Linton T, Tumminello C, Hastings SN. Cohort Profile: Baseline Characteristics of Veterans from Improving Veteran Access to Integrated Management of Back Pain (AIM-Back) - an Embedded Pragmatic, Cluster Randomized Trial in the United States. medRxiv [Preprint]. 2024 Nov 26:2024.11.23.24317833. doi: 10.1101/2024.11.23.24317833.
- 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. Study manuals and clinical tools will be shared with the NIH PMC3 Collaboratory and VA health care system facilities. 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. This study is not recruiting at the moment.
Susan N Hastings, MD principal investigator
Duke University / Durham VA
Steven Z George, PT, PhD 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 testing Pain modulation with physical pain treatment, Telephone delivered self-management counseling for increasing physical activity and Telephone delivered behavioral treatment for participants with high risk for continued disability in people with Low Back Pain and Veterans Family, 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 4 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 27 Jun 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?
Yes. Results are posted in the registry (first posted 27 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Measure (time frame: Baseline, three months post baseline). 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 NCT04411420, which also lists 7 linked publications.
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 27 Jun 2025.