Improving Access to Chiropractic Care in Community Health Centers

NCT06104605 | Active Not Recruiting

• 2 other identifiers: H-41930K23AT010487
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Keywords

Chiropractic care; Primary care provider; Chiropractor referrals; Chronic pain; Non-pharmacologic treatment; Community health centers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Percentage of patient participants referred to physical therapy

  14 months

• Percentage of patient participants referred to acupuncture

  14 months

• Percentage of patient participants prescribed opioids

  14 months

• Percentage of patient participants referred to magnetic resonance imaging (MRI)

  14 months

• Percentage of patient participants that receive epidural injections

  14 months

Study Arms (2)

Implementation

EXPERIMENTAL

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

Other: Institutional interventions; Other: PCPs interventions; Other: Patient interventions

Standard of care

NO INTERVENTION

Usual patient care without deployment of intervention.

Interventions

Institutional interventions 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.

Implementation

PCPs interventions 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.

Implementation

Patient interventions 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.

Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 39979943 DERIVED

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric J Roseen, DC

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a stepped-wedge design. 3 CHCs will be randomized to receive the intervention either first, second, or third two months apart.

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)