Chiropractic Care for Multiple Sclerosis

Overseen By Carla R Lima, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must be taking: Disease modifying therapy

Disqualifiers: Uncontrolled hypertension, Spinal surgery, Pregnancy, others

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

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how chiropractic care might affect people with multiple sclerosis (MS), particularly those with relapsing-remitting symptoms. Researchers aim to determine if spinal manipulation, a type of chiropractic treatment, can alter levels of certain proteins linked to inflammation. Participants will receive either actual spinal manipulation or a sham treatment (placebo spinal manipulation) to compare effects. Ideal candidates for this trial have been diagnosed with MS in the last five years, have not experienced a relapse in the past month, and are new to chiropractic care. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in chiropractic care for MS.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you are on stable FDA-approved disease modifying therapy for MS.

What prior data suggests that this spinal manipulation is safe for individuals with multiple sclerosis?

Research has shown that spinal manipulation is generally safe for people with various health conditions. One study found it effective and safe for chronic spine pain, with no serious side effects. Another study, which used Medicare data, compared chiropractic care to other treatments and found it well-tolerated by older adults.

For people with multiple sclerosis (MS), research found that chiropractic care helped reduce symptoms like fatigue and pain without major side effects. While more research is needed, especially for MS, current evidence suggests spinal manipulation is a safe option for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for multiple sclerosis (MS) focus on managing symptoms or slowing disease progression through medications like interferons or monoclonal antibodies. However, spinal manipulation is unique because it offers a non-drug approach that may help alleviate symptoms by targeting the alignment and function of the spine. Researchers are excited about this technique because it could provide an alternative or complementary option with fewer side effects than traditional medications. Additionally, the hands-on nature of spinal manipulation may improve mobility and offer relief from some MS symptoms, potentially enhancing the quality of life for patients.

What evidence suggests that spinal manipulation might be an effective treatment for multiple sclerosis?

Research has shown that spinal manipulation, one of the treatments studied in this trial, might help manage multiple sclerosis (MS) by affecting the immune system. Specifically, evidence indicates that chiropractic care can influence cytokines, proteins involved in inflammation. Some studies found that spinal manipulation can be as effective as other treatments for long-term spinal pain, common in people with MS. Additionally, chiropractic care has been linked to improvements in fatigue, pain, and muscle spasms for those with MS. While more research is needed for firm conclusions, these findings suggest spinal manipulation may offer benefits in managing MS symptoms. Participants in this trial may receive either spinal manipulation or sham spinal manipulation, which serves as a control. ^{1 2 4 6 7}

Who Is on the Research Team?

William R Reed, DC, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults aged 18-55 with a recent diagnosis of relapsing-remitting Multiple Sclerosis (MS), who are stable on FDA-approved MS medications, and have not had an MS flare-up in the past month. They should be new to chiropractic care, free from major diseases or conditions that affect the heart, lungs, or metabolism, and must not have had spinal surgery or bone fractures recently.

Inclusion Criteria

You have not received chiropractic care before.

Acceptance of informed consent.

I have not had a relapse in the last 30 days.

Exclusion Criteria

Your blood pressure is very high and not controlled with medication.

Unable to understand English or follow simple instruction.

I have had spinal surgery or recent bone fractures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 thoracic spinal manipulation treatments over 4 weeks

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in cytokine levels and secondary outcomes after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham Spinal Manipulation
• Spinal Manipulation

Trial Overview

The study tests if chiropractic care can influence immune markers in people with MS. Participants will receive either real spinal manipulation treatments or sham (fake) ones over four weeks to see how their cytokine levels change immediately after treatment and cumulatively.

How Is the Trial Designed?

Group I: Spinal Manipulation Experimental Treatment 1 Intervention

The spinal manipulation (SM) group will receive manually delivered SM limited to the thoracic spine.

Group II: Sham Spinal Manipulation Placebo Group 1 Intervention

Sham-spinal manipulation will be delivered by setting the expansion control knob on an Activator II (Activator Methods®) device to the zero position (off; no thrust) and placed onto the dorsal thumb surface of the clinician. At a setting of zero, no excursion of the Activator II stylus occurs, despite the device delivering an audible clicking sound, with no biomechanical force being imparted.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

Spinal manipulation has moderate quality evidence supporting its effectiveness in treating acute lumbar radiculopathy, indicating it can be a beneficial intervention for this specific condition.

For chronic lumbar and cervical spine-related extremity symptoms, the evidence is low or very low, and there is currently no evidence supporting spinal manipulation for thoracic radiculopathy, highlighting the need for further high-quality research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal manipulation or mobilization for radiculopathy: a systematic review. Leininger, B., Bronfort, G., Evans, R., et al.[2018]

Spinal manipulation, a common chiropractic treatment for musculoskeletal pain, involves high-velocity thrusts aimed at correcting spinal alignment, but its effectiveness remains uncertain based on randomized clinical trials.

A case study of a 45-year-old woman who experienced complete paraplegia after a chiropractic maneuver highlights potential risks, including vascular injury, even in the absence of spinal cord compression, suggesting that the risk/benefit ratio should be carefully considered for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute paraplegia after chiropraxis. Lopez-Gonzalez, A., Peris-Celda, M.[2021]

In a study of 69 patients with cervical spine pain, both matched and unmatched thoracic spine manipulations led to improvements in pain and disability, indicating that the direction of manipulation may not significantly impact outcomes.

The results suggest that specific directional manipulation of hypomobile thoracic segments is not necessary for effective treatment of neck pain, highlighting the need for further research on various treatment factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of direction specific thoracic spine manipulation on the cervical spine: a randomized controlled trial. Karas, S., Olson Hunt, MJ., Temes, B., et al.[2023]

A systematic review of 75 studies on spinal manipulation revealed that it is primarily used for treating back and neck pain, with high patient satisfaction reported, especially in North America, Europe, and Australia.

Chiropractors, osteopaths, and physical therapists are the main providers of spinal manipulation, and while it's more common in adults, children may receive it for non-musculoskeletal issues more frequently than adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiology: spinal manipulation utilization. Hurwitz, EL.[2018]

A case report highlights that thoracic disc herniations can present with non-specific back pain and may not always result in neurological deficits, suggesting the need for thorough diagnostic evaluation, including MRI, in persistent cases.

The report emphasizes the importance of cautious chiropractic manipulation, recommending testing maneuvers and considering contraindications, especially in patients with structural lesions or neurological deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Thoracic intervertebral disk displacement: a rare differential diagnosis of segmental irritation--guidelines for use of chiropractic therapy]. Kestlmeier, R., Reinisch, M., Trappe, AE.[2011]

Three serious neurological adverse events were reported in patients following chiropractic manipulation, including a vertebro-basilar stroke, neuropraxic injury of radial nerves, and a cervical epidural hematoma.

These cases suggest a potential causal relationship between chiropractic treatment and serious neurological complications, highlighting the need for a risk alert system to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chiropractic manipulation: reasons for concern? Gouveia, LO., Castanho, P., Ferreira, JJ., et al.[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 960,140 chiropractic spinal manipulative therapy (SMT) sessions involving 54,846 patients, only two severe adverse events (rib fractures) were reported, resulting in an incidence of 0.21 per 100,000 sessions, which is significantly lower than the hypothesized rate of <1 per 100,000.

No severe adverse events related to serious conditions like stroke or cauda equina syndrome were observed, indicating that severe complications from SMT are very rare and suggesting a favorable safety profile for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective analysis of the incidence of severe adverse events among recipients of chiropractic spinal manipulative therapy. Chu, EC., Trager, RJ., Lee, LY., et al.[2023]

A systematic review of 10 randomized controlled trials involving 677 patients found that thoracic spine manipulation (TSM) can provide therapeutic benefits for some individuals with non-specific neck pain, although its effectiveness compared to control treatments is not clearly established.

While TSM showed significant reductions in pain and disability in some studies, there is insufficient evidence to conclude that it is more effective than other interventions like cervical spine manipulation or electrotherapy, suggesting it may be best used in combination with other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of thoracic spine manipulation on pain and disability in patients with non-specific neck pain: a systematic review. Huisman, PA., Speksnijder, CM., de Wijer, A.[2019]

A patient with rheumatoid arthritis and acute thoracic pain improved significantly after receiving a specific spinal manipulation technique, despite initially being unresponsive to generalized manipulative treatments.

This case emphasizes the importance of clinical experience and patient preferences in managing conditions with limited research, suggesting that tailored interventions can be effective even in patients with comorbidities like rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of spinal manipulation in a rheumatoid patient presenting with acute thoracic pain: a case report. Chung, CL., Mior, SA.[2020]

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]

Citations

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Spinal manipulation treatment will be limited to the thoracic spine. Secondary outcomes will include determining the impact of 8 thoracic spinal manipulations ...

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The present study provides strong evidence that massage therapy could alleviate fatigue, pain, and spasms in MS patients, while reflexology plays a positive ...

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In summary, SMT may be as effective as other recommended therapies for the management of non-specific and chronic primary spine pain, including standard medical ...

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sciencedirect.com

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Chiropractic care has shown efficacy in the treatment of chronic spinal pain. Chiropractic care may represent a viable treatment option for the MS patient ...

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journal.parker.edu/article/94424-the-exploration-of-potential-spinal-manipulation-effects

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There is some evidence showing spinal manipulation and chiropractic care can impact both HRV and spinal thermography. One study showed ...

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The evidence supports the use of SMT as an effective and safe intervention for reducing pain, improving CROM, and decreasing disability in patients with ANP.