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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding chiropractic care (also known as Spinal Manipulation Therapy or Manual Therapy) to usual medical treatment can reduce the need for opioids in adults with long-term back or neck pain unrelated to cancer. Participants will either continue their regular medical care or receive additional chiropractic care alongside it. The trial seeks adults in Ontario, Canada, who have experienced chronic spinal pain for at least 12 weeks and are currently taking opioids but wish to lower their dose. As an unphased trial, it offers participants the opportunity to explore alternative treatments that may help reduce opioid dependency.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that chiropractic care is generally safe for treating back pain. Studies indicate that serious side effects from spinal manipulative therapy (SMT), a key part of chiropractic care, are rare. Although reports of nerve damage exist, such events are uncommon. Most people who receive chiropractic care do not experience severe problems.

Evidence also suggests that combining chiropractic care with regular medical care can improve low back pain. Patients often feel better when they receive chiropractic treatments alongside their usual medical treatment.

When performed by trained and licensed professionals, chiropractic care remains safe, keeping the risk of complications low. Overall, research suggests that most people tolerate chiropractic care well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about integrating chiropractic care with usual medical care for back pain because it offers a holistic approach to treatment. While standard care often involves medication and physical therapy, chiropractic care focuses on spinal adjustments to enhance the body's overall function. This method may provide a non-invasive alternative to pain relief, potentially reducing the need for medications that can have side effects. By combining both chiropractic and usual medical practices, there's hope for improved pain management and overall patient outcomes.

What evidence suggests that chiropractic care might be an effective treatment for chronic spinal pain?

Research has shown that chiropractic care, particularly spinal manipulative therapy (SMT), can be as effective as other recommended treatments for managing long-term spine pain. A 2019 review found that SMT provides similar pain relief to other treatments for chronic low back pain. Another study found that SMT works as well as standard therapies and might even be slightly more effective than some other treatments. In this trial, one group of participants will receive usual medical care, while another group will receive both usual medical care and chiropractic care. Evidence suggests that adding chiropractic care to regular medical care could help manage chronic non-cancer spine pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Peter C Emary, DC, PhD

Principal Investigator

McMaster University

Jason W Busse, DC, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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. 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).

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

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

4. bmj.com bmj.com/content/364/bmj.l689

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

5. 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.

6. acatoday.org acatoday.org/research/what-research-shows/

What Research Shows About Chiropractic 94% of the manual-thrust manipulation group achieved greater than 30% reduction in pain compared with 69% of usual medical care.” Schneider et al (2015), Spine.

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. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2680417

Effect of Usual Medical Care Plus Chiropractic Care vs ... Conclusions and Relevance Chiropractic care, when added to usual medical care, resulted in moderate short-term improvements in low back pain ...