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Effects of Chiropractic Care on Cytokine Levels in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Manipulation
Sham Spinal Manipulation
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring chiropractic, spinal manipulation, multiple sclerosis, cytokines

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Spinal Manipulation

Sham Spinal Manipulation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Serum inflammatory cytokine levels
Determine changes in serum inflammatory cytokine levels from baseline
Serum inflammatory cytokine levels
Determine changes in serum inflammatory cytokine levels from baseline
Serum inflammatory cytokine levels
Determine changes in serum inflammatory cytokine levels from baseline

Secondary Outcome Measures

Fatigue Severity Scale
Determine changes in fatigue from baseline. It is a 9 item scale determining fatigue severity and its effect on a person's activities
Fatigue Severity Scale
Determine changes in fatigue from baseline. It is a 9 item scale determining fatigue severity and its effect on a person's activities
Modified Fatigue Impact Scale
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.
Modified Fatigue Impact Scale
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.
Cognitive Processing Speed
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.
Cognitive Processing Speed
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.
Short-form McGill Pain Questionnaire
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.
Short-form McGill Pain Questionnaire
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.
Hospital Anxiety Depression Scale
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.
Hospital Anxiety Depression Scale
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.
Insomnia Severity Index
Determine changes in sleep quality from baseline. This is a 7 item instrument to assess components of nighttime and daytime insomnia
Insomnia Severity Index
Determine changes in sleep quality from baseline. This is a 7 item instrument to assess components of nighttime and daytime insomnia
Nine-Hole Peg Test
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.
Nine-Hole Peg Test
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.
Timed 25 foot Walk Test
Determine changes in lower limb mobility from baseline. Evaluates leg function and quantitative mobility in a timed 25 foot walk.
Timed 25 foot Walk Test
Determine changes in lower limb mobility from baseline. Evaluates leg function and quantitative mobility in a timed 25 foot walk.

Full Information

First Posted
April 27, 2021
Last Updated
December 15, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04972929
Brief Title
Effects of Chiropractic Care on Cytokine Levels in Multiple Sclerosis
Official Title
Effects of Chiropractic Care on Pro- and Anti-inflammatory Cytokine Levels in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
chiropractic, spinal manipulation, multiple sclerosis, cytokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
e plan to conduct a randomized pilot parallel-group randomized controlled trial (RCT) with appropriate SM and Sham SM treatment groups.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal Manipulation
Arm Type
Experimental
Arm Description
The spinal manipulation (SM) group will receive manually delivered SM limited to the thoracic spine.
Arm Title
Sham Spinal Manipulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Spinal Manipulation
Other Intervention Name(s)
chiropractic care
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Sham Spinal Manipulation
Intervention Description
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 Measure Information:
Title
Serum inflammatory cytokine levels
Description
Determine changes in serum inflammatory cytokine levels from baseline
Time Frame
Week 1 (at baseline)
Title
Serum inflammatory cytokine levels
Description
Determine changes in serum inflammatory cytokine levels from baseline
Time Frame
Week 1 (after 1st treatment
Title
Serum inflammatory cytokine levels
Description
Determine changes in serum inflammatory cytokine levels from baseline
Time Frame
Week 4 (after 8th treatment)
Secondary Outcome Measure Information:
Title
Fatigue Severity Scale
Description
Determine changes in fatigue from baseline. It is a 9 item scale determining fatigue severity and its effect on a person's activities
Time Frame
Week 1 (at baseline)
Title
Fatigue Severity Scale
Description
Determine changes in fatigue from baseline. It is a 9 item scale determining fatigue severity and its effect on a person's activities
Time Frame
Week 4 (after 8th treatment)
Title
Modified Fatigue Impact Scale
Description
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.
Time Frame
Week 1 (at baseline)
Title
Modified Fatigue Impact Scale
Description
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.
Time Frame
Week 4 (after 8th treatment)
Title
Cognitive Processing Speed
Description
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.
Time Frame
Week 1 (at baseline)
Title
Cognitive Processing Speed
Description
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.
Time Frame
Week 4 (after 8th treatment)
Title
Short-form McGill Pain Questionnaire
Description
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.
Time Frame
Week 1 (at baseline)
Title
Short-form McGill Pain Questionnaire
Description
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.
Time Frame
Week 4 (after 8th treatment)
Title
Hospital Anxiety Depression Scale
Description
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.
Time Frame
Week 1 (at baseline)
Title
Hospital Anxiety Depression Scale
Description
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.
Time Frame
Week 4 (after 8th treatment)
Title
Insomnia Severity Index
Description
Determine changes in sleep quality from baseline. This is a 7 item instrument to assess components of nighttime and daytime insomnia
Time Frame
(Week 1 (at baseline)
Title
Insomnia Severity Index
Description
Determine changes in sleep quality from baseline. This is a 7 item instrument to assess components of nighttime and daytime insomnia
Time Frame
Week 4 (after 8th treatment)
Title
Nine-Hole Peg Test
Description
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.
Time Frame
Week 1 (at baseline)
Title
Nine-Hole Peg Test
Description
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.
Time Frame
Week 4 (after 8th treatment)
Title
Timed 25 foot Walk Test
Description
Determine changes in lower limb mobility from baseline. Evaluates leg function and quantitative mobility in a timed 25 foot walk.
Time Frame
Week 1 (at baseline)
Title
Timed 25 foot Walk Test
Description
Determine changes in lower limb mobility from baseline. Evaluates leg function and quantitative mobility in a timed 25 foot walk.
Time Frame
Week 4 (after 8th treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William R Reed, DC, PhD
Phone
2059343261
Email
WREED@UAB.EDU
First Name & Middle Initial & Last Name or Official Title & Degree
Carla R Lima, MS
Phone
2059341588
Email
clima@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William R Reed, DC, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William R Reed
Phone
205-934-3261
Email
WREED@UAB.EDU

12. IPD Sharing Statement

Learn more about this trial

Effects of Chiropractic Care on Cytokine Levels in Multiple Sclerosis

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