Chiropractic Care for Back Pain

(ACCESS-DC Trial)

Overseen By Jason W Busse, DC, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Must be taking: Opioids

Must not be taking: Methadone, Naloxone

Disqualifiers: Chiropractic care, Opioid naive, Spinal neoplasms, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will conduct a pilot cluster randomized controlled trial (RCT) of chiropractic care added to usual medical care, versus usual medical care alone, for adult patients prescribed opioid therapy for chronic non-cancer spinal pain at four community health centers (CHCs) in Ontario, Canada. These centers provide services to communities and vulnerable populations with high unemployment rates, multiple co-morbidities, and high rates of chronic musculoskeletal disorders that are commonly managed with prescription opioids. The investigators hypothesize that a full-scale (definitive) cluster RCT on the impact of chiropractic care on prescription opioid use for chronic non-cancer spinal pain will be feasible within the Ontario CHC context.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on adding chiropractic care to your usual medical care, so you may continue your current medications unless told otherwise by the trial team.

What data supports the effectiveness of the treatment Chiropractic Care for Back Pain?

Research shows that manual therapy, which includes techniques like spinal manipulation and mobilization, can significantly reduce pain and the need for sick leave in patients with low-back pain compared to conventional treatment. Additionally, chiropractic care has shown long-term benefits for patients with chronic low back pain, especially when patients are actively involved in their self-care. ^{1 2 3 4 5}

Is chiropractic care generally safe for humans?

Chiropractic care, including spinal manipulation, is generally safe for humans, with most adverse events being mild and temporary. Serious complications are extremely rare, occurring in about 1 per 400,000 to 2 million manipulations. ^{6 7 8 9 10}

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

Chiropractic care for back pain is unique because it involves spinal manipulation therapy, which uses hands-on techniques to adjust the spine and improve alignment. This approach is often considered safer, more cost-effective, and results in higher patient satisfaction compared to usual medical care, and it has been shown to be effective in numerous studies. ^{2 11 12 13 14}

Research Team

Peter C Emary, DC, PhD

Principal Investigator

McMaster University

Jason W Busse, DC, PhD

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for adults in Ontario with chronic non-cancer spinal pain who have been on opioids for at least 3 months and are interested in reducing their opioid use. They must be able to understand the study and give informed consent. People already getting chiropractic care, using low-dose opioids, treated for opioid misuse, or with certain serious spine conditions can't join.

Inclusion Criteria

I am an adult with long-term back or neck pain not caused by cancer, using opioids and want to reduce my dose.

Clusters: CHC in Ontario, Canada with a roster of ≥ 3,500 patients and one or more opioid-reducing strategies implemented as part of their standard medical services (e.g., chart audits, tracked performance metrics related to high dose prescribing)

Exclusion Criteria

Participants who are opioid-naive (or < 90 consecutive days of opioid prescription) at baseline, have a total active opioid dosage of < 50 mg MED at baseline, are actively receiving treatment for opioid use disorder (e.g., methadone, naloxone), have spinal neoplasms or other 'red flag' diagnoses (e.g., fractures, infections, inflammatory arthritis, or cauda equina syndrome), anticipate problems with being available for follow-up, are incarcerated or planned for incarceration, are or may be enrolled in a competing trial, or have other reasons specified for exclusion

I am currently receiving chiropractic treatments.

My health center employs chiropractors or has a chiropractic program.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 weeks of usual medical care plus chiropractic care or usual medical care alone

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

Data Collection and Analysis

Data on opioid use, pain, disability, and quality of life are collected and analyzed

26 weeks

Treatment Details

Interventions

• Chiropractic Care
• Usual Medical Care

Trial Overview The study tests if adding chiropractic care to usual medical treatments helps reduce opioid use more than usual medical treatments alone. It's a pilot randomized controlled trial conducted at community health centers serving high-need areas.

Participant Groups

Group I: Usual Medical Care + Chiropractic Care Experimental Treatment 1 Intervention

This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care plus chiropractic care.

Group II: Usual Medical Care Active Control 1 Intervention

This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care.

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?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Canadian Chiropractic Research Foundation

Collaborator

Trials

2

Recruited

270+

Ontario Chiropractic Association

Collaborator

Trials

1

Recruited

30+

Alliance for Healthier Communities

Collaborator

Trials

1

Recruited

30+

Surgical Methods Centre, McMaster University

Collaborator

Trials

1

Recruited

30+

Michael G. DeGroote Institute for Pain Research and Care

Collaborator

Trials

1

Recruited

30+

Michael G. DeGroote National Pain Centre

Collaborator

Trials

1

Recruited

30+

Findings from Research

In a study involving 104 patients with chronic low back pain, combining spinal manipulative therapy (SMT) with pain neuroscience education (PNE) did not show immediate benefits in reducing pain intensity or disability compared to SMT alone.

However, the combination of SMT and PNE resulted in longer-lasting improvements in pain intensity and disability at 90 and 180 days, suggesting that PNE may enhance the effectiveness of SMT over time, potentially through increased pain self-efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Additional effect of pain neuroscience education to spinal manipulative therapy on pain and disability for patients with chronic low back pain: a randomized controlled trial. Tavares, FAG., Rossiter, JVA., Lima, GCL., et al.[2023]

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]

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]

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]

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]

References

1. 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]

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

Chiropractic management of postoperative spine pain: a report of 3 cases. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

Additional effect of pain neuroscience education to spinal manipulative therapy on pain and disability for patients with chronic low back pain: a randomized controlled trial. [2023]

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

Comparison of Treatment Outcomes in Nonspecific Low-Back Pain Patients With and Without Modic Changes Who Receive Chiropractic Treatment. [2019]

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. England pubmed.ncbi.nlm.nih.gov

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

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

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

8. 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]

9. 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]

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

Risks associated with spinal manipulation. [2019]

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

Family physicians, chiropractors, and back pain. [2017]

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

The Chiropractic Hospital-Based Interventions Research Outcomes Study: Consistency of Outcomes Between Doctors of Chiropractic Treating Patients With Acute Lower Back Pain. [2015]

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

History and overview of theories and methods of chiropractic: a counterpoint. [2006]

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

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