Chiropractic Care for Lower Back Pain

Overseen By Maya Williams, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on increasing referrals to chiropractic care for lower back pain.

What data supports the effectiveness of this treatment for lower back pain?

Research shows that chiropractic care can be as effective as hospital outpatient treatment for managing lower back pain, and patients who choose chiropractic care may experience better long-term outcomes. Additionally, quality improvement strategies in chiropractic settings have led to sustainable improvements in care for lower back pain. ^{1 2 3 4 5}

Is chiropractic care for lower back pain safe?

Chiropractic care is generally safe, with most adverse events being mild and temporary. Serious complications are extremely rare, making the risks of serious adverse events negligible. ^{6 7 8 9 10}

How does chiropractic care differ from other treatments for lower back pain?

Chiropractic care for lower back pain is unique because it is a non-drug therapy that focuses on spinal adjustments and manual manipulation to improve function and reduce pain. Unlike traditional medical treatments that may rely on medication or surgery, chiropractic care emphasizes a hands-on approach and often results in a more favorable outcome in terms of ability to work and reduced need for bedrest and medication. ^{2 5 11 12 13}

What is the purpose of this trial?

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.

Research Team

Eric J Roseen, DC

Principal Investigator

Boston Medical Center

Eligibility Criteria

This trial is for adults with lower back pain who visit community health centers in the Boston area. It includes patients, primary care providers (MDs, DOs, NPs, or PAs), and the health centers themselves if they agree to participate.

Inclusion Criteria

You have consented to take part in the study.

I have been diagnosed with lower back pain.

You are a CHC patient in the Boston area who primarily accesses care from their primary provider.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation strategies are piloted in community health centers to increase PCP referrals to chiropractic care for LBP

8 weeks

Multiple visits (in-person and virtual) for PCPs and patients

Follow-up

Participants are monitored for changes in referral rates and other secondary outcomes

14 months

Treatment Details

Interventions

• Institutional interventions, PCPs interventions, Patient interventions

Trial Overview The study tests new ways to get more primary care doctors to refer patients with lower back pain to chiropractic treatments. It involves educational materials for patients and training seminars for doctors, plus changes in electronic health records.

Participant Groups

Group I: Implementation Experimental Treatment 3 Interventions

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

Group II: Standard of care Active Control 1 Intervention

Usual patient care without deployment of intervention.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

A study analyzing health insurance claims in New Hampshire found that adults receiving chiropractic services for low back pain had a 51% lower likelihood of experiencing adverse drug events (ADEs) compared to those who did not use chiropractic care.

While the study indicates a significant association between chiropractic service utilization and reduced risk of ADEs, it does not establish a causal relationship, highlighting the need for further research with larger datasets and improved methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Utilization of Chiropractic Services for Treatment of Low Back Pain and Risk of Adverse Drug Events. Whedon, JM., Toler, AWJ., Goehl, JM., et al.[2019]

Chiropractic care for neck or low-back pain is generally safe, with most adverse events being benign and self-limiting.

The incidence of severe complications from chiropractic manipulation is extremely low, making it a useful therapy with negligible risks for serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events following chiropractic care for subjects with neck or low-back pain: do the benefits outweigh the risks? Rubinstein, SM.[2022]

A systematic review of five studies on spinal manipulation (SM) found that about half of patients experience mild and transient adverse events after treatment, indicating that while side effects are common, they are generally not severe.

There is currently no reliable data on the incidence of serious adverse events related to spinal manipulation, suggesting that while they are likely rare, further research is needed to better understand their frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective investigations into the safety of spinal manipulation. Ernst, E.[2019]

Between 2004 and 2012, there were 338 compensation claims related to chiropractic care in Denmark and Norway, with 300 claims analyzed; only 13.7% of these claims were approved for financial compensation, indicating a low approval rate compared to other healthcare providers.

The most common complaints included worsening symptoms after treatment and alleged disk herniations, with a significant portion of compensation costs linked to a few cases of serious adverse events like cervical artery dissection, suggesting that better patient education on treatment expectations could help reduce claims.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compensation claims for chiropractic in Denmark and Norway 2004-2012. Jevne, J., Hartvigsen, J., Christensen, HW.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Randomised comparison of chiropractic and hospital outpatient management for low back pain: results from extended follow up. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Low back pain of mechanical origin: randomised comparison of chiropractic and hospital outpatient treatment. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Application of incremental change strategies in chiropractic and multidisciplinary clinical settings for quality improvement. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Results of chiropractic treatment of lumbopelvic fixation in 44 patients admitted to an orthopedic department. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

A descriptive study of medical and chiropractic patients with chronic low back pain and sciatica: management by physicians (practice activities) and patients (self-management). [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Association Between Utilization of Chiropractic Services for Treatment of Low Back Pain and Risk of Adverse Drug Events. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Assessing Adverse Events After Chiropractic Care at a Chiropractic Teaching Clinic: An Active-Surveillance Pilot Study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse events following chiropractic care for subjects with neck or low-back pain: do the benefits outweigh the risks? [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Prospective investigations into the safety of spinal manipulation. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Compensation claims for chiropractic in Denmark and Norway 2004-2012. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Chiropractic treatment of low back pain: a prospective survey. [2006]

12. England pubmed.ncbi.nlm.nih.gov

Veteran Response to Dosage in Chiropractic Therapy (VERDICT): Study Protocol of a Pragmatic Randomized Trial for Chronic Low Back Pain. [2021]

13. England pubmed.ncbi.nlm.nih.gov

The rationale for primary spine care employing biopsychosocial, stratified and diagnosis-based care-pathways at a chiropractic college public clinic: a literature review. [2021]