Chiropractic Care for Lower Back Pain

(VERDICT Trial)

Recruiting at 3 trial locations

Overseen By Elissa Twist, DC, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Palmer College of Chiropractic

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

766 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates how Veterans with chronic low back pain (cLBP) respond to varying doses of chiropractic therapy and how health services utilization are impacted as a result. There are 2 phases in this study. In Phase 1, half of participants will receive a low dose (1-5 visits) of chiropractic care for 10 weeks, while the other half will receive a higher dose (8-12 visits) for 10 weeks. At the end of Phase 1, participants in each group will be randomized again to receive either chronic chiropractic pain management (CCPM) (1 scheduled chiropractic visit per month x 10 months) or no CCPM for 10 months.

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 data supports the effectiveness of chiropractic care for lower back pain?

Research shows that manual therapy, including spinal manipulation and mobilization, can lead to less pain, reduced disability, and faster recovery compared to conventional treatments for lower back pain. Patients receiving manual therapy also reported lower drug consumption and less time on sick leave. ^{1 2 3 4 5}

Is chiropractic care for lower back pain safe?

Chiropractic care, including spinal manipulation, is generally safe for treating lower back pain. Most people experience mild and temporary side effects, while serious complications are extremely rare. ^{6 7 8 9 10}

How is chiropractic care different from other treatments for lower back pain?

Chiropractic care, specifically spinal manipulation therapy, is unique because it involves hands-on adjustments to the spine to improve alignment and relieve pain, unlike other treatments that may focus on exercises, heat application, or medication. It is often recommended for its safety and effectiveness, especially for older adults with chronic low back pain. ^{11 12 13 14 15}

Research Team

Christine Goertz, DC, PhD

Principal Investigator

Duke University

Cynthia Long, PhD

Principal Investigator

Palmer Center for Chiropractic Research (PCCR)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Patient-centered outcomes of high-velocity, low-amplitude spinal manipulation for low back pain: a systematic review. [2022]

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

A controlled, multicentre trial of manual therapy in low-back pain. Initial status, sick-leave and pain score during follow-up. [2022]

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

Clinical assessment of manipulation and mobilization of the lumbar spine. A critical review of the literature. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

A randomized study of manual therapy with steroid injections in low-back pain. Telephone interview follow-up of pain, disability, recovery and drug consumption. [2022]

6. 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]

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

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

8. England pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Adverse events after manual therapy among patients seeking care for neck and/or back pain: a randomized controlled trial. [2022]

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

Beliefs, perceptions and practices of chiropractors and patients about mitigation strategies for benign adverse events after spinal manipulation therapy. [2023]

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

Mechanical therapy for low back pain. [2022]

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

Chiropractic technique procedures for specific low back conditions: characterizing the literature. [2018]

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

Spinal manipulative therapy for low back pain. A meta-analysis of effectiveness relative to other therapies. [2022]

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

A randomized controlled trial comparing 2 types of spinal manipulation and minimal conservative medical care for adults 55 years and older with subacute or chronic low back pain. [2022]

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

Congruence between decisions to initiate chiropractic spinal manipulation for low back pain and appropriateness criteria in North America. [2019]