Chiropractic Care for Lower Back Pain

(VERDICT Trial)

No longer recruiting at 3 trial locations

Overseen By Elissa Twist, DC, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Palmer College of Chiropractic

Disqualifiers: Chiropractic contraindications, Moving, Hospice, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how varying amounts of chiropractic care affect Veterans with chronic lower back pain (cLBP). Participants will initially receive either a low or high dose of chiropractic visits over 10 weeks. Afterward, they will be randomly assigned to either continue with monthly chiropractic care for 10 months or stop treatment. Veterans with ongoing back pain and related disability who are willing to attend chiropractic sessions for up to a year might be suitable for this study. As an unphased trial, it offers Veterans an opportunity to explore personalized chiropractic care options for managing chronic lower back pain.

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 chiropractic care for lower back pain.

What prior data suggests that chiropractic care is safe for treating chronic low back pain?

Research has shown that chiropractic care, particularly for the lower back, is generally safe when performed by a trained professional. Studies have found that most people experience mild to moderate side effects, such as temporary soreness or discomfort, while serious problems are rare. Although some individuals might feel a bit stiff or sore after a session, major issues are uncommon. Seeing a trained chiropractor is important for optimal results and safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for chronic lower back pain, which often includes medications, physical therapy, or surgery, this trial explores the potential of chiropractic care as a distinct, non-invasive treatment. Researchers are excited about testing different "doses" of chiropractic visits to see how they impact pain management. They are also curious about the long-term benefits of continued chiropractic care compared to no ongoing treatment. This approach could offer a drug-free alternative that focuses on manual adjustments and holistic management, potentially reducing reliance on medications and their associated side effects.

What evidence suggests that chiropractic care is effective for chronic low back pain?

Research has shown that chiropractic care, particularly spinal manipulative therapy (SMT), can be as effective as other recommended treatments for long-term low back pain. Studies have found that SMT provides similar pain relief to standard medical care. Specifically, a 2019 review found that SMT works as well as other methods for managing chronic low back pain. Additionally, SMT appears slightly more effective than some treatments not usually recommended. This trial will compare different doses of chiropractic care, including SMT, to evaluate their effectiveness in relieving pain in chronic low back pain conditions. Overall, evidence supports that chiropractic care, including SMT, can help relieve pain in these conditions. ^{3 6 7 8 9}

Who Is on the Research Team?

Christine Goertz, DC, PhD

Principal Investigator

Duke University

Cynthia Long, PhD

Principal Investigator

Palmer Center for Chiropractic Research (PCCR)

Are You a Good Fit for This Trial?

This trial is for Veterans aged 18 or older with chronic low back pain who can attend chiropractic sessions for up to a year. They must understand the study, not be under current chiropractic care, and not planning to move within three months. Those with conditions that prohibit chiropractic care or are in other pain treatment studies cannot join.

Inclusion Criteria

Able to comprehend study details without need for a proxy

I can go to chiropractic appointments for up to a year.

I have pain and difficulty moving because of my lower back.

Exclusion Criteria

I am able to understand and agree to the study's requirements.

I do not have any health issues that prevent me from receiving chiropractic care.

No phone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants receive either a low dose (1-5 visits) or a higher dose (8-12 visits) of chiropractic care for 10 weeks

10 weeks

1-12 visits (in-person)

Phase 2 Treatment

Participants receive either chronic chiropractic pain management (CCPM) with monthly visits or no CCPM for 10 months

10 months

0-10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chiropractic Care

Trial Overview The study tests how different doses of chiropractic therapy affect chronic low back pain in Veterans over two phases: one group gets a lower dose (1-5 visits) and another gets higher (8-12 visits) for 10 weeks. Afterwards, they may receive monthly care or no further treatment for ten months.

How Is the Trial Designed?

Group I: Phase 1: Low Dose (1-5 visits) Active Control 1 Intervention

Veterans with cLBP who will be randomly allocated to undergo a course of a low dose (1-5 visits) of multimodal, evidence-based chiropractic care for 10 weeks (Phase 1).

Group II: Phase 1: Higher Dose (8-12 visits) Active Control 1 Intervention

Veterans with cLBP who will be randomly allocated to undergo a course of a higher dose (8-12 visits) of multimodal, evidence-based chiropractic care for 10 weeks (Phase 1).

Group III: Phase 2: CCPM Active Control 1 Intervention

After Phase 1, Veterans with cLBP who will be randomly allocated again to receive chiropractic chronic pain management (CCPM) consisting of scheduled monthly chiropractic care for 10 months.

Group IV: Phase 2: No CCPM Active Control 1 Intervention

After Phase 1, Veterans with cLBP who will be randomly allocated again to receive no CCPM in which they will receive no chiropractic care for 10 months.

Chiropractic Care is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Chiropractic Care for:

• Musculoskeletal disorders
• Neck pain
• Back pain
• Headaches

Approved in Canada as Chiropractic Care for:

• Musculoskeletal disorders
• Neck pain
• Back pain
• Headaches

Approved in European Union as Chiropractic Care for:

• Musculoskeletal disorders
• Neck pain
• Back pain
• Headaches

Who Is Running the Clinical Trial?

Palmer College of Chiropractic

Lead Sponsor

Trials

19

Recruited

4,700+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Office of Research on Women's Health (ORWH)

Collaborator

Trials

34

Recruited

36,300+

VA Greater Los Angeles Healthcare System

Collaborator

Trials

53

Recruited

8,700+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

Iowa City VA Health Care System

Collaborator

Trials

4

Recruited

35,700+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

VA Connecticut Healthcare System

Collaborator

Trials

86

Recruited

8,800+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

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]

In a study of 767 patients seeking treatment for back and neck pain, adverse events after manual therapy were common, with 51% experiencing at least one event, primarily muscle soreness, increased pain, and stiffness.

The type of manual therapy used (including or excluding spinal manipulation or stretching) did not significantly affect the occurrence of adverse events, but women reported more short and long moderate adverse events compared to men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial. Paanalahti, K., Holm, LW., Nordin, M., et al.[2022]

A significant number of patients (55%) reported experiencing benign adverse events (AEs) like pain and stiffness after spinal manipulative therapy (SMT), highlighting the need for effective management strategies.

While most chiropractors believe in the occurrence of benign AEs and attempt mitigation strategies, only a small percentage of patients feel these strategies are implemented, indicating a gap in communication and patient education that could enhance care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beliefs, perceptions and practices of chiropractors and patients about mitigation strategies for benign adverse events after spinal manipulation therapy. Funabashi, M., Pohlman, KA., Goldsworthy, R., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8915715/

Clinical Effectiveness and Efficacy of Chiropractic Spinal ... SMT may be as effective as other recommended therapies for the management of non-specific and chronic primary spine pain, including standard medical care or ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35295422/

Clinical Effectiveness and Efficacy of Chiropractic Spinal ... SMT may be as effective as other recommended therapies for the management of non-specific and chronic primary spine pain, including standard medical care or ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0031940621000250

The effect of spinal manipulative therapy on pain relief and ... A 2019 review concluded that spinal manipulative therapy (SMT) results in similar benefit compared to other interventions for chronic low back pain (LBP).

4. jospt.org jospt.org/doi/10.2519/jospt.2025.12707

The Effectiveness of Spinal Manipulative Therapy in ... Most SMT procedures were equal to clinical guideline interventions and were slightly more effective than other treatments.

5. bmj.com bmj.com/content/364/bmj.l689

Benefits and harms of spinal manipulative therapy for the ... SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1905885/

Adverse effects of spinal manipulation: a systematic review Spinal manipulation, particularly when performed on the upper spine, is frequently associated with mild to moderate adverse effects.

7. mayoclinic.org mayoclinic.org/tests-procedures/chiropractic-adjustment/about/pac-20393513

Chiropractic adjustment Chiropractic adjustments are safe when they are done by someone trained and licensed to do chiropractic care. Serious complications linked to ...

8. chiromt.biomedcentral.com chiromt.biomedcentral.com/articles/10.1186/s12998-017-0168-5

What are the risks of manual treatment of the spine? A scoping ... Existing literature indicates that benign adverse events following manual treatments to the spine are common, while serious adverse events are rare.

9. nccih.nih.gov nccih.nih.gov/health/spinal-manipulation-what-you-need-to-know

Spinal Manipulation: What You Need To Know | NCCIH This fact sheet summarizes the current scientific knowledge about the effects of spinal manipulation on low-back pain and other conditions.