Improving Access to Chiropractic Care in Community Health Centers

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.

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 Overview

• Status: Active, not recruiting
• Conditions: Lower Back Pain
• Intervention / Treatment: Other: Institutional interventions; Other: Patient interventions; Other: PCPs interventions

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria for CHCs:

• Be a CHC in the Boston area with primary care
• Agree to participate in study

Inclusion criteria for PCPs:

• Work at a participating CHC
• Be an MD, doctor of osteopathy (DO), nurse practitioner (NP), or physician assistant (PA)

Inclusion criteria for patients with LBP:

• Has PCP at participating CHC
• Has LBP diagnosis
• Is 18 years of age or older

Exclusion criteria for CHCs:

• There are no exclusion criteria

Exclusion criteria for PCPs:

• There are no exclusion criteria

Exclusion criteria for patients with LBP:

• There are no exclusion criteria for adult patients with LBP

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implementation; Implementation will be deployed at the CHC, PCP, and patient level.	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.; Other: 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.; 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.
No Intervention: Standard of care; Usual patient care without deployment of intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the fourteen month study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patient participants referred to physical therapy	Information for this outcome will be abstracted from the participants' medical records	14 months
Percentage of patient participants referred to acupuncture	Information for this outcome will be abstracted from the participants' medical records	14 months
Percentage of patient participants prescribed opioids	Information for this outcome will be abstracted from the participants' medical records	14 months
Percentage of patient participants referred to magnetic resonance imaging (MRI)	Information for this outcome will be abstracted from the participants' medical records	14 months
Percentage of patient participants that receive epidural injections	Information for this outcome will be abstracted from the participants' medical records	14 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Eric J Roseen, DC, Boston Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Chronic pain; Primary care provider; Chiropractic care; Chiropractor referrals; Non-pharmacologic treatment; Community health centers
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Low Back Pain
• Other Study ID Numbers: H-41930; K23AT010487 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No