26 Participants Needed

Chiropractic Care for Multiple Sclerosis

WR
CR
Overseen ByCarla R Lima, MS
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
Must be taking: Disease modifying therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Multiple sclerosis (MS) is an inflammatory autoimmune disease associated with an imbalance between pro- and anti-inflammatory markers (cytokines) resulting in a demyelinating and neurodegenerative disease. There is early evidence that spinal manipulation (chiropractic care) is better than control in influencing immune (cytokine) activity in asymptomatic participants, but few studies have been completed in participants with chronic inflammatory conditions, such as MS. The purpose of this project is to examine the immediate (after a single thoracic spinal manipulation treatment) and summative impact (after 8 thoracic spinal manipulation treatments occurring over 4 weeks) on pro-inflammatory (interleukin (IL) IL-1ß, IL-2, IL-6, Tumor necrosis factor-alpha) and anti-inflammatory (IL-4, IL-10) plasma cytokines 20 minutes and 2 hours after thoracic spinal manipulation in participants diagnosed with neuroinflammatory relapsing-remitting MS (RR-MS). Spinal manipulation treatment will be limited to the thoracic spine. Secondary outcomes will include determining the impact of 8 thoracic spinal manipulations on fatigue, cognitive processing speed, pain, depression, sleep, and motor function through questionnaires and performance of various in assessments such as the timed 25 foot walk test.

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 data supports the effectiveness of the treatment Chiropractic Care for Multiple Sclerosis?

There is evidence that thoracic spine manipulation, a component of chiropractic care, is effective in treating neck pain, which suggests it may help with pain management in other conditions. However, the effectiveness of spinal manipulation specifically for multiple sclerosis is not directly supported by the available research.12345

Is chiropractic care generally safe for humans?

Chiropractic care, including spinal manipulation, is generally considered safe for humans, with most adverse events being mild and temporary. Serious complications are very rare, but they can occur, so it's important to be aware of the risks.678910

How is spinal manipulation different from other treatments for multiple sclerosis?

Spinal manipulation, often used by chiropractors, is unique because it involves adjusting the spine to correct alignment and relieve nerve pressure, which is different from typical drug treatments for multiple sclerosis that focus on managing symptoms or modifying the disease. This hands-on approach is more commonly used for back and neck pain, and its effectiveness for multiple sclerosis is still uncertain.1241112

Research Team

WR

William R Reed, DC, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

I am between 18 and 55 years old.
You have not received chiropractic care before.
Acceptance of informed consent.
See 6 more

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.
See 1 more

Treatment Details

Interventions

  • Sham Spinal Manipulation
  • Spinal Manipulation
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Spinal ManipulationExperimental Treatment1 Intervention
The spinal manipulation (SM) group will receive manually delivered SM limited to the thoracic spine.
Group II: Sham Spinal ManipulationPlacebo Group1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Findings from Research

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.
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.
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.
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]

References

Spinal manipulation or mobilization for radiculopathy: a systematic review. [2018]
Acute paraplegia after chiropraxis. [2021]
The effect of direction specific thoracic spine manipulation on the cervical spine: a randomized controlled trial. [2023]
Epidemiology: spinal manipulation utilization. [2018]
The effect of thoracic spine manipulation on pain and disability in patients with non-specific neck pain: a systematic review. [2019]
Adverse events following chiropractic care for subjects with neck or low-back pain: do the benefits outweigh the risks? [2022]
Chiropractic manipulation: reasons for concern? [2022]
Prospective investigations into the safety of spinal manipulation. [2019]
Compensation claims for chiropractic in Denmark and Norway 2004-2012. [2018]
A retrospective analysis of the incidence of severe adverse events among recipients of chiropractic spinal manipulative therapy. [2023]
[Thoracic intervertebral disk displacement: a rare differential diagnosis of segmental irritation--guidelines for use of chiropractic therapy]. [2011]
Use of spinal manipulation in a rheumatoid patient presenting with acute thoracic pain: a case report. [2020]