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Effects of Chiropractic Care on Cytokine Levels in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT04972929
Recruitment Status : Not yet recruiting
First Posted : July 22, 2021
Last Update Posted : November 1, 2022
Sponsor:
Information provided by (Responsible Party):
William R Reed DC, PhD, University of Alabama at Birmingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Other: Spinal Manipulation Other: Sham Spinal Manipulation Not Applicable

Detailed Description:

Study Design. The investigators plan to conduct a pilot parallel-group randomized controlled trial with appropriate SM and Sham SM treatment groups. Randomization will occur with the sequence being completed prior to enrolling the first participant and with concealed allocation by a member of the team not involved with the outcomes or treatments. The investigators designed the Sham SM treatments to ensure all participants have similar amounts of physical contact and clinician interaction (i.e. contextual environment for placebo-related improvement). The primary and secondary outcomes of the study will be assessed and processed by blinded assessors who are not part of the intervention delivery to reduce any potential bias in collected outcomes.

SM Delivery. Diversified (i.e. crossed bilateral hypothenar contact) chiropractic technique will be administered at levels of identified spinal joint restriction/dysfunction (derived from thoracic spine x-rays, static and motion palpation, and confirmed or provoked localized tenderness in paraspinal soft tissues). Participants in the SM and Sham SM group will be scheduled for 8 office visits (2x/wk) over a period of 4 weeks.

The Sham-SM will be delivered by setting the expansion control knob on an Activator II (Activator Methods®, Phoenix AZ) device to the zero position (off; no thrust) and placed onto the dorsal thumb surface of the clinician (no actual instrument contact with study participant). 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 to the participant.

Primary Outcome Variable. To examine the immediate (1x) and summative impact of SM (8x/4wk) on pro-inflammatory and anti-inflammatory plasma cytokine levels at 20 minutes and 2 hours post-SM (after the first and 8th treatment) and compared to baseline measures.

Secondary Outcome Variables. To examine the summative and secondary impact of 8 chiropractic treatments over 4 weeks on RR-MS-related fatigue (Fatigue Severity Scale, Modified Fatigue Impact Scale), cognitive processing speed (Symbol Digit Modalities Test), pain (short-form McGill Pain Questionnaire), depression (Hospital Anxiety Depression Scale), subjective sleep (Insomnia Severity Index) and upper/lower body motor function (Nine-Hole Peg Test, Timed 25 foot Walk Test). These secondary outcomes will be measured before onset of treatment (baseline) and upon completion of 8 spinal manipulation treatments over the period of 4 weeks) (2 visits per week).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: e plan to conduct a randomized pilot parallel-group randomized controlled trial (RCT) with appropriate SM and Sham SM treatment groups.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The chiropractic clinician will not be blinded in order to deliver the assigned treatment (spinal manipulation or Sham spinal manipulation) but all other assessors and study personnel will be blinded to the group assignment.
Primary Purpose: Treatment
Official Title: Effects of Chiropractic Care on Pro- and Anti-inflammatory Cytokine Levels in Multiple Sclerosis
Estimated Study Start Date : December 15, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spinal Manipulation
The spinal manipulation (SM) group will receive manually delivered SM limited to the thoracic spine.
Other: Spinal Manipulation
Diversified (i.e. crossed bilateral hypothenar contact) chiropractic technique will be administered at levels of identified spinal joint restriction/dysfunction (derived from thoracic spine x-rays, static and motion palpation, and confirmed or provoked localized tenderness in paraspinal soft tissues).
Other Name: chiropractic care

Sham Comparator: Sham Spinal Manipulation
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.
Other: Sham Spinal Manipulation
Sham-SM will be delivered by setting the expansion control knob on an Activator II (Activator Methods®, Phoenix AZ) device to the zero position (off; no thrust) and placed onto the dorsal thumb surface of the clinician (no actual instrument contact with study participant). 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 to the participant.




Primary Outcome Measures :
  1. Serum inflammatory cytokine levels [ Time Frame: Week 1 (at baseline) ]
    Determine changes in serum inflammatory cytokine levels from baseline

  2. Serum inflammatory cytokine levels [ Time Frame: Week 1 (after 1st treatment ]
    Determine changes in serum inflammatory cytokine levels from baseline

  3. Serum inflammatory cytokine levels [ Time Frame: Week 4 (after 8th treatment) ]
    Determine changes in serum inflammatory cytokine levels from baseline


Secondary Outcome Measures :
  1. Fatigue Severity Scale [ Time Frame: Week 1 (at baseline) ]
    Determine changes in fatigue from baseline. It is a 9 item scale determining fatigue severity and its effect on a person's activities

  2. Fatigue Severity Scale [ Time Frame: Week 4 (after 8th treatment) ]
    Determine changes in fatigue from baseline. It is a 9 item scale determining fatigue severity and its effect on a person's activities

  3. Modified Fatigue Impact Scale [ Time Frame: Week 1 (at baseline) ]
    Determine changes in fatigue and tiredness from baseline. It is a 21 item scale that provides a more in-depth look at the impact of fatigue and lack of energy might have on mental alertness and daily activities.

  4. Modified Fatigue Impact Scale [ Time Frame: Week 4 (after 8th treatment) ]
    Determine changes in fatigue and tiredness from baseline. It is a 21 item scale that provides a more in-depth look at the impact of fatigue and lack of energy might have on mental alertness and daily activities.

  5. Cognitive Processing Speed [ Time Frame: Week 1 (at baseline) ]
    Determine changes in cognitive (rapid) processing speed from baseline. Assesses the time it takes to complete a mental task and is related to the speed at which a person can understand and react to a set of information that they receive.

  6. Cognitive Processing Speed [ Time Frame: Week 4 (after 8th treatment) ]
    Determine changes in cognitive (rapid) processing speed from baseline. Assesses the time it takes to complete a mental task and is related to the speed at which a person can understand and react to a set of information that they receive.

  7. Short-form McGill Pain Questionnaire [ Time Frame: Week 1 (at baseline) ]
    Determine changes in pain from baseline. There are 2 subscales with 11 words (sensory dimension) and 4 words (Affective dimension) with selections of none, mild, moderate and severe along with a visual analog scale and present pain intensity description.

  8. Short-form McGill Pain Questionnaire [ Time Frame: Week 4 (after 8th treatment) ]
    Determine changes in pain from baseline. There are 2 subscales with 11 words (sensory dimension) and 4 words (Affective dimension) with selections of none, mild, moderate and severe along with a visual analog scale and present pain intensity description.

  9. Hospital Anxiety Depression Scale [ Time Frame: Week 1 (at baseline) ]
    Determine changes in anxiety/depression from baseline. This is a 14 item instrument that you respond to inquires related about you have felt during the last week.

  10. Hospital Anxiety Depression Scale [ Time Frame: Week 4 (after 8th treatment) ]
    Determine changes in anxiety/depression from baseline. This is a 14 item instrument that you respond to inquires related about you have felt during the last week.

  11. Insomnia Severity Index [ Time Frame: (Week 1 (at baseline) ]
    Determine changes in sleep quality from baseline. This is a 7 item instrument to assess components of nighttime and daytime insomnia

  12. Insomnia Severity Index [ Time Frame: Week 4 (after 8th treatment) ]
    Determine changes in sleep quality from baseline. This is a 7 item instrument to assess components of nighttime and daytime insomnia

  13. Nine-Hole Peg Test [ Time Frame: Week 1 (at baseline) ]
    Determine changes in upper limb coordination from baseline. This is a standardized timed assessment to assess finger dexterity in which 9 wooden pegs are placed into predrilled holes in a block of wood.

  14. Nine-Hole Peg Test [ Time Frame: Week 4 (after 8th treatment) ]
    Determine changes in upper limb coordination from baseline. This is a standardized timed assessment to assess finger dexterity in which 9 wooden pegs are placed into predrilled holes in a block of wood.

  15. Timed 25 foot Walk Test [ Time Frame: Week 1 (at baseline) ]
    Determine changes in lower limb mobility from baseline. Evaluates leg function and quantitative mobility in a timed 25 foot walk.

  16. Timed 25 foot Walk Test [ Time Frame: Week 4 (after 8th treatment) ]
    Determine changes in lower limb mobility from baseline. Evaluates leg function and quantitative mobility in a timed 25 foot walk.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04972929


Contacts
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Contact: William R Reed, DC, PhD 2059343261 WREED@UAB.EDU
Contact: Carla R Lima, MS 2059341588 clima@uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: William R Reed, DC, PhD University of Alabama at Birmingham
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Responsible Party: William R Reed DC, PhD, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04972929    
Other Study ID Numbers: 300007021
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by William R Reed DC, PhD, University of Alabama at Birmingham:
chiropractic
spinal manipulation
multiple sclerosis
cytokines
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases