Lower Back PainNCT06104605
Improving Access to Chiropractic Care in Community Health Centers
A study testing Institutional interventions, PCPs interventions and Patient interventions in people with Lower Back Pain, run by Boston Medical Center at 1 site in United States.
Trial summary
The goal of this study is to evaluate the feasibility of new implementation strategies designed to increase the number of Primary Care Providers (PCPs) referrals to chiropractic care for lower back pain (LBP) in underserved populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- Institutional interventions, PCPs interventions and Patient interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a CHC in the Boston area with primary care
- Agree to participate in study
- Work at a participating CHC
- Be an MD, doctor of osteopathy (DO), nurse practitioner (NP), or physician assistant (PA)
- Has PCP at participating CHC
- Has LBP diagnosis
- Is 18 years of age or older
Who cannot join
- There are no exclusion criteria
- There are no exclusion criteria
- There are no exclusion criteria for adult patients with LBP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Access to Chiropractic Care for Low Back Pain in Underserved Primary Care Settings: A Protocol for a Pilot Study of a Multi-level Implementation Strategy
The goal of this study is to evaluate the feasibility of new implementation strategies designed to increase the number of Primary Care Providers (PCPs) referrals to chiropractic care for lower back pain (LBP) in underserved populations. The investigators plan to pilot the strategies in three qualified community health centers (CHCs) and compare the number of LBP patients who receive referrals before and after implementation. The implementation strategies involve PCP, patient, and organizational interventions.
Patients presenting with LBP will be provided educational materials that focus on the safety and effectiveness of chiropractic care as an evidence-based treatment for LBP. Materials will be available in CHC common areas and may be sent to patients by their PCP via patient portal.
Read more
PCPs will participate in interactive lunch seminars to allow for inter-professional learning for PCPs. They will also participate in a survey regarding their attitudes and beliefs relating to chiropractic care. Currently, many PCPs cannot make chiropractic care referrals in the electronic health record (EHR). The investigators plan to add this option, or make it easier if the referral is already available.
This multi-level, multi-component approach will last two months, and will be rolled out sequentially in three clinics using a stepped-wedge design. The ordering of clinics will be random.
The primary outcome is the proportion of patients with LBP who received a referral to chiropractic care before and after the intervention. Secondary outcomes include referral to any non-pharmacologic treatment, use of imaging, and prescribed medications.
- Conditions
- Lower Back Pain
- Being tested
- Institutional interventions, PCPs interventions, Patient interventions
- Keywords
- Chiropractic care, Primary care provider, Chiropractor referrals, Chronic pain, Non-pharmacologic treatment, Community health centers
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Institutional interventionsOther
Intervention will include, but not be limited to, the following: adding a referral option to chiropractic care in the electronic health record (EHR), optimizing referral option, e.g., creating a list of preferred providers. Additional strategies may be added depending on community health center staff engagement prior to implementation.
PCPs interventionsOther
Two one-hour interactive grand rounds/lunch seminars that allow for inter-professional learning for PCPs with optional continuing education credits for PCPs.
Short teaching cases involving clinical vignettes developed with local doctors of chiropractic (DCs), information about DCs (e.g., evidence-base for treatments), and logistics of the referral process (e.g., geographic location of community-based DCs who accept Medicaid) sent to participating providers unable to attend the seminars. Additional strategies may be added depending on primary care provider engagement prior to implementation.
Patient interventionsOther
Printed and electronic educational materials (e.g., brochures) written at a sixth grade reading level in English and Spanish that present chiropractic as a safe and effective evidence-based treatment for LBP. These materials will be written, reviewed, and revised by the researchers with CHC patient input. Additional strategies may be added depending on patient engagement prior to implementation.
| Study group | Role | What they receive |
|---|---|---|
| Implementation | Experimental | Implementation will be deployed at the CHC, PCP, and patient level. Receives: Other: Institutional interventions; Other: PCPs interventions; Other: Patient interventions |
| Standard of care | No intervention | Usual patient care without deployment of intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PCP Chiropractor Referrals for LBP
This outcome will be assessed by calculating the proportion of LBP patients receiving a chiropractic referral for the two timeframe periods will be calculated. The numerator will be those with a chiropractic referral, defined as those LBP patients who received a PCP referral in the EHR or documentation in the EHR of a visit with a chiropractor. The denominator will be the total number of unique LBP patients seen by a PCP with an LBP diagnosis in the EHR.
Measured: During the fourteen month study period
Secondary outcomes (5)
Percentage of patient participants referred to physical therapy
Information for this outcome will be abstracted from the participants' medical records
Measured: 14 months
Percentage of patient participants referred to acupuncture
Information for this outcome will be abstracted from the participants' medical records
Measured: 14 months
Percentage of patient participants prescribed opioids
Information for this outcome will be abstracted from the participants' medical records
Measured: 14 months
Percentage of patient participants referred to magnetic resonance imaging (MRI)
Information for this outcome will be abstracted from the participants' medical records
Measured: 14 months
Percentage of patient participants that receive epidural injections
Information for this outcome will be abstracted from the participants' medical records
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Nov 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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 Lower Back PainStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a stepped-wedge design. 3 CHCs will be randomized to receive the intervention either first, second, or third two months apart.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Eric J Roseen, DC, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104605
- Sponsor's protocol ID
- H-41930
- Other IDs
- K23AT010487
- Status last verified
- Jun 2026
- First submitted
- 23 Oct 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roseen EJ, Bussieres A, Reichman R, Bora C, Trieu J, Austad K, Williams C, Fischer RA, Parrilla D, Laird LD, LaValley M, Evans RL, Saper RB, Morone NE. A multi-level implementation strategy to increase adoption of chiropractic care for low back pain in primary care clinics: a randomized stepped-wedge pilot study protocol. Chiropr Man Therap. 2025 Feb 20;33(1):9. doi: 10.1186/s12998-024-00565-w.
PubMed 39979943
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Chiropractic Care for Low Back Pain in Underserved Primary Care Settings: A Protocol for a Pilot Study of a Multi-level Implementation Strategy
- ClinicalTrials.gov ID
- NCT06104605
- Acronym / sponsor ID
- H-41930
- Conditions
- Lower Back Pain
- Keywords
- Chiropractic care, Primary care provider, Chiropractor referrals, Chronic pain, Non-pharmacologic treatment, Community health centers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Oct 2023 (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 study is to evaluate the feasibility of new implementation strategies designed to increase the number of Primary Care Providers (PCPs) referrals to chiropractic care for lower back pain (LBP) in underserved populations. The investigators plan to pilot the strategies in three qualified community health centers (CHCs) and compare the number of LBP patients who receive referrals before and after implementation. The implementation strategies involve PCP, patient, and organizational interventions.
Patients presenting with LBP will be provided educational materials that focus on the safety and effectiveness of chiropractic care as an evidence-based treatment for LBP. Materials will be available in CHC common areas and may be sent to patients by their PCP via patient portal.
PCPs will participate in interactive lunch seminars to allow for inter-professional learning for PCPs. They will also participate in a survey regarding their attitudes and beliefs relating to chiropractic care. Currently, many PCPs cannot make chiropractic care referrals in the electronic health record (EHR). The investigators plan to add this option, or make it easier if the referral is already available.
This multi-level, multi-component approach will last two months, and will be rolled out sequentially in three clinics using a stepped-wedge design. The ordering of clinics will be random.
The primary outcome is the proportion of patients with LBP who received a referral to chiropractic care before and after the intervention. Secondary outcomes include referral to any non-pharmacologic treatment, use of imaging, and prescribed medications.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a stepped-wedge design. 3 CHCs will be randomized to receive the intervention either first, second, or third two months apart.
| Arm | Type | Receives |
|---|---|---|
| Implementation | Experimental | Other: Institutional interventions, Other: PCPs interventions, Other: Patient interventionsImplementation will be deployed at the CHC, PCP, and patient level. |
| Standard of care | No intervention | –Usual patient care without deployment of intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be a CHC in the Boston area with primary care
- Agree to participate in study
- Work at a participating CHC
- Be an MD, doctor of osteopathy (DO), nurse practitioner (NP), or physician assistant (PA)
- Has PCP at participating CHC
Key exclusion criteria (3 listed)
- There are no exclusion criteria
- There are no exclusion criteria
- There are no exclusion criteria for adult patients with 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 |
|---|---|---|
| Institutional interventionsIntervention will include, but not be limited to, the following: adding a referral option to chiropractic care in the electronic health record (EHR), optimizing referral option, e.g., creating a list of preferred providers. Additional strategies may be added depending on community health center staff engagement prior to implementation. | Other | Implementation |
| PCPs interventionsTwo one-hour interactive grand rounds/lunch seminars that allow for inter-professional learning for PCPs with optional continuing education credits for PCPs. Short teaching cases involving clinical vignettes developed with local doctors of chiropractic (DCs), information about DCs (e.g., evidence-base for treatments), and logistics of the referral process (e.g., geographic location of community-based DCs who accept Medicaid) sent to participating providers unable to attend the seminars. Additional strategies may be added depending on primary care provider engagement prior to implementation. | Other | Implementation |
| Patient interventionsPrinted and electronic educational materials (e.g., brochures) written at a sixth grade reading level in English and Spanish that present chiropractic as a safe and effective evidence-based treatment for LBP. These materials will be written, reviewed, and revised by the researchers with CHC patient input. Additional strategies may be added depending on patient engagement prior to implementation. | Other | Implementation |
Primary outcome
Change in PCP Chiropractor Referrals for LBP
Time frame: During the fourteen month study period
This outcome will be assessed by calculating the proportion of LBP patients receiving a chiropractic referral for the two timeframe periods will be calculated. The numerator will be those with a chiropractic referral, defined as those LBP patients who received a PCP referral in the EHR or documentation in the EHR of a visit with a chiropractor. The denominator will be the total number of unique LBP patients seen by a PCP with an LBP diagnosis in the EHR.
5 secondary outcomes
Percentage of patient participants referred to physical therapy
Time frame: 14 months
Percentage of patient participants referred to acupuncture
Time frame: 14 months
Percentage of patient participants prescribed opioids
Time frame: 14 months
Percentage of patient participants referred to magnetic resonance imaging (MRI)
Time frame: 14 months
Percentage of patient participants that receive epidural injections
Time frame: 14 months
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 1 Jul 2026.
- Derived from this study: PubMed 39979943Roseen EJ, Bussieres A, Reichman R, Bora C, Trieu J, Austad K, Williams C, Fischer RA, Parrilla D, Laird LD, LaValley M, Evans RL, Saper RB, Morone NE. A multi-level implementation strategy to increase adoption of chiropractic care for low back pain in primary care clinics: a randomized stepped-wedge pilot study protocol. Chiropr Man Therap. 2025 Feb 20;33(1):9. doi: 10.1186/s12998-024-00565-w.
- Individual participant dataSharing planned: No
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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.
Eric J Roseen, DC principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Institutional interventions, PCPs interventions and Patient interventions in people with Lower Back Pain, run by Boston Medical Center 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 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?
Change in PCP Chiropractor Referrals for LBP (time frame: During the fourteen month study period). 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 NCT06104605, 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 1 Jul 2026.