Chiropractic Maintenance Care for Back Pain

Overseen By Martha Funabashi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Memorial Chiropractic College

Disqualifiers: Pregnancy, Cancer, Osteoporosis, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the MAINTAIN instrument can improve care for people with back and neck pain. Participants will receive either standard chiropractic care or a more personalized approach guided by the MAINTAIN instrument. The researchers aim to determine if this tool reduces pain days and improves treatment outcomes. This trial suits individuals who have experienced recurring back or neck pain for over a month in the past year but have had no pain in the last three months. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance future treatment options for back and neck 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's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that chiropractic maintenance care is safe for back pain patients?

Research has shown that chiropractic maintenance care is generally safe for treating back pain. In one study, patients experienced mild pain and slight improvements over three months. Another study found that this care reduced the number of days with bothersome low back pain more quickly and maintained these benefits over time. These findings suggest that most patients tolerate the treatment well, with no major safety concerns reported.

It's important to remember that these studies focus on chiropractic maintenance care as a whole. The treatment's safety can vary based on individual health conditions. Always consult a healthcare provider to determine if this treatment is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring chiropractic maintenance care for back pain because it offers a more personalized approach compared to standard chiropractic treatments. This method tailors the frequency and type of care based on a patient's response, using a tool called the MAINTAIN instrument to determine the best candidates for ongoing maintenance. Unlike traditional symptom-based care, which addresses issues as they arise, this approach proactively schedules treatments at regular intervals, potentially preventing relapses and managing symptoms more effectively over time.

What evidence suggests that this trial's treatments could be effective for back pain?

Studies have shown that regular chiropractic care can reduce the number of days with bothersome low back pain. In this trial, participants will be assigned to different treatment arms to evaluate the effectiveness of chiropractic maintenance care. One study found that patients who received regular chiropractic care experienced 13 fewer days of pain over a year compared to those without regular follow-up visits. Another study demonstrated that regular care was more effective than treating symptoms only when they appear, in reducing pain days over a year. This approach involves planned visits, which helps manage pain better than waiting for it to worsen before seeking help. Overall, research suggests that regular chiropractic care can lead to faster and longer-lasting pain relief. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people with recurring and significant spinal pain (neck, mid-back, or low back) lasting more than 30 days in the past year. Participants must not have had a pain episode in the last 3 months and should be able to use a mobile phone and email.

Inclusion Criteria

I have had significant spinal pain for more than 30 days in the past year.

Ability to send and receive SMS (text messages)

I have a mobile phone and an email address.

Exclusion Criteria

I have a diagnosed spinal condition like radiculopathy or spinal stenosis.

I do not have any serious conditions like severe injuries, cancer, infections, or bone issues.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

All participating patients receive pragmatic chiropractic care for the initial 3 weeks (6 visits) and home exercise recommendations

3 weeks

6 visits (in-person)

Stratified Maintenance Care

Participants classified as very good candidates for maintenance care receive tapering manual treatments and home exercise recommendations, with pre-planned visits at 4-12 week intervals

4-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Chiropractic maintenance care
• Standard chiropractic care

Trial Overview

The study tests if using the MAINTAIN instrument improves care for back and neck pain patients by guiding them to either standard chiropractic care or ongoing maintenance treatments based on their specific needs.

How Is the Trial Designed?

Group I: Stratified Maintenance Care Experimental Treatment 1 Intervention

All participating patients will receive pragmatic chiropractic care for the initial 3 weeks (6 visits) and home exercise recommendations. Participants in the Stratified Maintenance Care group will be classified based on the MAINTAIN instrument into: not a candidate, good candidate, and very good candidate for maintenance care: * Participants showing a good response to the initial care and classified as not a candidate or a good candidate for maintenance care will be given home exercise recommendations. Return for further manual treatment will be recommended if they have a relapse or exacerbation of symptoms (symptom-guided care). * Participants classified as having a good response to the initial care and very good candidates for maintenance care, will have visits with tapering manual treatments and home exercise recommendations. They will then be recommended maintenance care with pre-planned visits at 4-12 week intervals (aiming at increasing the interval as soon as possible).

Group II: Standard Chiropractic Care Active Control 1 Intervention

All participating patients will receive pragmatic chiropractic care for the initial 3 weeks (6 visits) and home exercise recommendations. In the Standard chiropractic care group, participating patients will receive a standard (pragmatic) chiropractic care in which treatment will be provided based on the clinician's judgement and home exercise recommendations. This may or may not include maintenance care depending on the clinicians' standard operating procedures. All treatments provided will be recorded. Return for further treatment will be recommended if they have a relapse or exacerbation of symptoms (symptom-based).

Chiropractic maintenance care is already approved in European Union, United States for the following indications:

Approved in European Union as Chiropractic maintenance care for:

• Recurrent and persistent low back pain
• Neck pain

Approved in United States as Chiropractic maintenance care for:

• Chronic low back pain
• Recurrent spinal pain

Who Is Running the Clinical Trial?

Canadian Memorial Chiropractic College

Lead Sponsor

Trials

22

Recruited

2,800+

Parker University

Collaborator

Trials

13

Recruited

2,000+

Karolinska Institutet

Collaborator

Trials

1,510

Recruited

32,450,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Maintenance Care in chiropractic is defined as a preventive approach for patients with previous pain episodes who have responded well to initial treatment, and it is utilized by about 30% of Scandinavian chiropractic patients.

While there is some evidence suggesting that Maintenance Care may reduce the number of days with low back pain compared to patients who only seek care as needed, the overall results on pain and disability are mixed, and no studies have assessed its cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chiropractic maintenance care - what's new? A systematic review of the literature. Iben, A., Lise, H., Charlotte, LY.[2020]

A survey of 59 Swedish chiropractors revealed a general consensus on managing low back pain (LBP), particularly in deciding when to refer patients for second opinions or consider maintenance care.

Chiropractors tended to agree that patients with quick recovery and a history of recurring LBP should be considered for maintenance care, indicating a structured approach to ongoing treatment after initial recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nordic maintenance care program--case management of chiropractic patients with low back pain: a survey of Swedish chiropractors. Axén, I., Rosenbaum, A., Eklund, A., et al.[2021]

A significant majority (98%) of Swedish chiropractors believe that chiropractic care can help prevent future relapses of low back pain, indicating a strong confidence in its efficacy for long-term management.

When recommending maintenance care, chiropractors prioritize the frequency of past low back pain episodes, with over 70% considering it 'very important', and they suggest that substantial improvement (75% or more) is necessary before considering tertiary preventive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nordic Maintenance Care Program: when do chiropractors recommend secondary and tertiary preventive care for low back pain? Axén, I., Jensen, IB., Eklund, A., et al.[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]

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]

Patients receiving maintenance chiropractic care (MC) experienced fewer days with bothersome low back pain and more stable pain trajectories compared to those receiving treatment only during new episodes, particularly benefiting the dysfunctional subgroup.

The dysfunctional subgroup reported an increase of 9.8 weeks in total pain-free periods between episodes when receiving MC, indicating that this approach may enhance the overall management of recurrent and persistent low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nordic maintenance care program: maintenance care reduces the number of days with pain in acute episodes and increases the length of pain free periods for dysfunctional patients with recurrent and persistent low back pain - a secondary analysis of a pragmatic randomized controlled trial. Eklund, A., Hagberg, J., Jensen, I., et al.[2021]

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 328 patients with recurrent or persistent non-specific low back pain, Maintenance Care (MC) significantly reduced the total number of days with bothersome pain compared to symptom-guided treatment, with a mean reduction of 12.8 days over 52 weeks.

MC required more treatments (1.7 additional sessions on average) but did not result in any serious adverse events, suggesting it is a safe and effective option for patients who respond well to initial chiropractic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nordic Maintenance Care program: Effectiveness of chiropractic maintenance care versus symptom-guided treatment for recurrent and persistent low back pain-A pragmatic randomized controlled trial. Eklund, A., Jensen, I., Lohela-Karlsson, M., et al.[2019]

A 26-year-old female with chronic low back pain showed significant improvement in quality of life after 9 months of chiropractic maintenance care, with SF-36 scores increasing from low baseline values to near or above normal levels.

The patient reported a substantial reduction in pain, as indicated by a decrease in Visual Analog Scale scores from 8 to 1.5, alongside a reduction in the number of detected vertebral subluxations, suggesting enhanced spinal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chiropractic maintenance care and quality of life of a patient presenting with chronic low back pain. Wenban, AB., Nielsen, MK.[2015]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7171853/

maintenance care reduces the number of days with pain ...

A recent study showed that chiropractic patients had fewer days with bothersome (activity-limiting) low back pain (LBP) when receiving care at regular pre- ...

2.

chiromt.biomedcentral.com

chiromt.biomedcentral.com/articles/10.1186/s12998-019-0283-6

Chiropractic maintenance care - what's new? A systematic ...

A significant difference with 13 days less with bothersome pain over 12 months was noted in the group randomized to follow-up sessions scheduled ...

3.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0203029

Effectiveness of chiropractic maintenance care versus ...

MC was more effective than symptom-guided treatment in reducing the total number of days over 52 weeks with bothersome non-specific LBP but it resulted in a ...

4.

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 ...

5.

chiro-trust.org

chiro-trust.org/advanced/chiropractic-care-clinical-outcomesthe-value-maintenance-care/

Chiropractic Care Clinical OutcomesThe Value of ...

The maintenance group had a faster reduction in days with bothersome low back pain and reached a lower steady state earlier. Maintenance ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8667562/

Visit Frequency and Outcomes for Patients Using Ongoing ...

Unconditional (time-only) models showed patients on average had mild pain and function and significant, but slight improvements in these over the 3-month ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6135505/

The Nordic Maintenance Care program

The aim of this trial was to investigate the effectiveness of MC on pain trajectories for patients with recurrent or persistent LBP.

8.

chiro.org

chiro.org/Conditions/Chiropractic_Maintenance_Care_Whats_New.shtml

What's New? A Systematic Review of the Literature

Four studies investigating the effect of chiropractic Maintenance Care were identified, with disparate results on pain and disability of neck and back pain.