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

220 Participants Needed

Trial Summary

What is the purpose of this trial?

Previous studies showed that some back pain patients (with specific characteristics) present less days with pain when treated with chiropractic maintenance care. A clinical instrument (called MAINTAIN instrument) was developed to identify those patients who would benefit from chiropractic maintenance care. This study will investigate the impact of using the MAINTAIN instrument in clinical practice. This study will help to improve clinical care of patients with back and neck pain by providing them with more individualized care.

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

Research shows that chiropractic maintenance care can reduce the number of days with bothersome low back pain and increase pain-free periods for patients with recurrent and persistent low back pain. This approach involves regular, pre-planned treatments regardless of symptoms, which has been found to be more effective than only treating new episodes of pain. ^{1 2 3 4 5}

Is chiropractic maintenance care generally safe for humans?

Chiropractic maintenance care is generally safe, with most adverse events being mild and temporary. Serious complications are extremely rare. ^{1 2 6 7 8}

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

Chiropractic maintenance care is unique because it involves regular, pre-planned chiropractic sessions to prevent new episodes of back pain and maintain pain-free periods, rather than only treating symptoms when they arise. This approach is considered both secondary and tertiary preventive care, aiming to reduce the frequency and severity of back pain over time. ^{1 2 3 4 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

The Nordic maintenance care program--case management of chiropractic patients with low back pain: a survey of Swedish chiropractors. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Chiropractic maintenance care - what's new? A systematic review of the literature. [2020]

3. England 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. [2021]

4. United States 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. [2019]

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

Chiropractic maintenance care and quality of life of a patient presenting with chronic low back pain. [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

Adverse events following chiropractic care for subjects with neck or low-back pain: do the benefits outweigh the risks? [2022]

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

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

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

The Nordic Maintenance Care Program: when do chiropractors recommend secondary and tertiary preventive care for low back pain? [2022]