Improving Access to Chiropractic Care in Community Health Centers

NCT ID: NCT06104605

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-06-30

Brief 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. 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.

Conditions

Lower Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Implementation

Implementation will be deployed at the CHC, PCP, and patient level.

Group Type: EXPERIMENTAL

Patient interventions

Intervention Type: OTHER

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.

Institutional interventions

Intervention Type: OTHER

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 interventions

Intervention Type: OTHER

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.

Standard of care

Usual patient care without deployment of intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient interventions

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.

Intervention Type: OTHER

Institutional interventions

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.

Intervention Type: OTHER

PCPs interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric J Roseen, DC

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39979943 (View on PubMed)

Other Identifiers

K23AT010487

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-41930

Identifier Type: -

Identifier Source: org_study_id