Effects of Chiropractic Care on Cytokine Levels in Multiple Sclerosis

Effects of Chiropractic Care on Pro- and Anti-inflammatory Cytokine Levels in Multiple Sclerosis

CompletedNot a drug-phase studyRelapsing MSNCT04972929

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Spinal Manipulation

Placebo

  • Sham Spinal Manipulation

Results by group

IL-6 Serum Inflammatory Cytokine Levels

From baseline to after 8th treatment at 4 weeks

GroupValueIntervalNumber analysed
Spinal Manipulation/Trigger Point Therapy3.85 pg/mL6.01 (Standard Deviation)11
Sham-spinal Manipulation2.76 pg/mL4.77 (Standard Deviation)10

Spinal Manipulation/Trigger Point Therapy

3.85

Sham-spinal Manipulation

2.76

Mean Difference (Final Values) -0.24 (95% CI -0.78–0.30)

IL-4 Serum Inflammatory Cytokine Levels

From baseline to after 8th treatment at 4 weeks

GroupValueIntervalNumber analysed
Thoracic Spinal Manipulation/Trigger Point Therapy83.85 pg/ML187.51 (Standard Deviation)11
Sham-spinal Manipulation Group73.36 pg/ML198.6 (Standard Deviation)10

Thoracic Spinal Manipulation/Trigger Point Therapy

83.85

Sham-spinal Manipulation Group

73.36

Mean Difference (Final Values) -0.03 (95% CI -4.69–4.62)

IL-10 Serum Inflammatory Cytokine Levels

From baseline to after 8th treatment at 4 weeks

GroupValueIntervalNumber analysed
Thoracic Spinal Manipulation/Trigger Point Therapy12.01 pg/ML25.01 (Standard Deviation)11
Sham-manipulation Group8.82 pg/ML17.14 (Standard Deviation)10

Thoracic Spinal Manipulation/Trigger Point Therapy

12.01

Sham-manipulation Group

8.82

Mean Difference (Final Values) 0.15 (95% CI -1.32–1.85)

IL-2 Serum Inflammatory Cytokine Levels

From baseline to after 8th treatment at 4 weeks

GroupValueIntervalNumber analysed
Thoracic Spinal Manipulation & Trigger Point Therapy0.13 pg/mL0.43 (Standard Deviation)11
Sham Manipulation Group0.01 pg/mL1.12 (Standard Deviation)10

Thoracic Spinal Manipulation & Trigger Point Therapy

0.13

Sham Manipulation Group

0.01

Mean Difference (Final Values) 0.14 (95% CI -1.15–0.64)

TNFalpha Serum Inflammatory Cytokine

baseline to after 8th treatment at 4 weeks

GroupValueIntervalNumber analysed
Thoracic Spinal Manipulation and Trigger Point Therapy7.25 pg/ML5.52 (Standard Deviation)11
Sham Manipulation Group4.81 pg/ML4.83 (Standard Deviation)10

Thoracic Spinal Manipulation and Trigger Point Therapy

7.25

Sham Manipulation Group

4.81

Mean Difference (Final Values) 0.49 (95% CI -0.49–1.46)

IL-B Serum Cytokine Levels

baseline and 8th treatment after 4 weeks

GroupValueIntervalNumber analysed
Thoracic Spinal Maniplation and Trigger Point Therapy3.11 pg/mL3.59 (Standard Deviation)11
Sham Manipulation Group2.15 pg/mL3 (Standard Deviation)10

Thoracic Spinal Maniplation and Trigger Point Therapy

3.11

Sham Manipulation Group

2.15

Mean Difference (Final Values) 0.04 (95% CI -0.30–0.38)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Thoracic Spinal Manipulation/Trigger Point Therapy Group110 (0.0%)0
Sham-spinal Manipulation Group100 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • IL-6 Serum Inflammatory Cytokine Levels

    From baseline to after 8th treatment at 4 weeks

    Immune response

  • IL-4 Serum Inflammatory Cytokine Levels

    From baseline to after 8th treatment at 4 weeks

    Immune response

  • IL-10 Serum Inflammatory Cytokine Levels

    From baseline to after 8th treatment at 4 weeks

    Immune response

  • IL-2 Serum Inflammatory Cytokine Levels

    From baseline to after 8th treatment at 4 weeks

    Immune response

  • TNFalpha Serum Inflammatory Cytokine

    baseline to after 8th treatment at 4 weeks

    Immune response

  • IL-B Serum Cytokine Levels

    baseline and 8th treatment after 4 weeks

    Immune response

Other measures (8)

  • Fatigue Severity Scale (FSS)

    From Baseline to after 8th treatment at 4 weeks

    Fatigue

  • Modified Fatigue Impact Scale

    From baseline to after 8th treatment at 4 weeks

    Thinking and memoryFatigue

  • Cognitive Processing Speed

    From Baseline to after 8th treatment at 4 weeks

    Thinking and memory

  • Total Change in Pain Short-form McGill Pain Questionnaire

    From Baseline to after 8th treatment at 4 weeks

    Pain

  • Total Change in Hospital Anxiety Depression Scale

    From Baseline to after 8th treatment at 4 weeks

    Mood and sleep

  • Insomnia Severity Index

    From Baseline to after 8th treatment at 4 weeks

    Mood and sleep

  • Nine-Hole Peg Test

    From Baseline to after 8th treatment at 4 weeks

    Arm and hand function

  • Timed 25 Foot Walk Test

    From Baseline to after 8th treatment at 4 weeks

    Disability progressionWalking and mobility

Who could take part

Relapsing MS · 18 to 55

Show the full criteria

Inclusion criteria

* Age 18 to 55 years * Physician-confirmed diagnosis of MS within the last 5 years * Expanded Disability Status Scale (EDSS) score below 4 based on Neurostatus-certified examination * Relapse free in the last 30 days * No known cardiovascular, pulmonary, or metabolic disease * Currently on stable FDA-approved disease modifying therapy (eg, interferon beta-1a or beta-1b, natalizumab etc.) * Naïve to chiropractic care * No contraindications to spinal manipulation * Acceptance of informed consent. Exclusion criteria include: * Uncontrolled hypertension (systolic pressure >160 mmHg, diastolic blood pressure >95 mmHg) Any past spinal surgery or recent history of bone fractures * Pregnancy in the last 12 months * Unable to understand English or follow simple instruction.

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Sept 2023

    2. Main results due

      Mar 2025

    3. Finished

      Mar 2025

    4. Results posted

      Jul 2026

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