Clinical trial NCT04972929: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: chiropractic
spinal manipulation
multiple sclerosis
cytokines
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: e plan to conduct a randomized pilot parallel-group randomized controlled trial (RCT) with appropriate SM and Sham SM treatment groups.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Serum inflammatory cytokine levels
timeFrame: Week 1 (at baseline)
measure: Serum inflammatory cytokine levels
timeFrame: Week 1 (after 1st treatment
measure: Serum inflammatory cytokine levels
timeFrame: Week 4 (after 8th treatment)
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: Week 1 (at baseline)
measure: Fatigue Severity Scale
timeFrame: Week 4 (after 8th treatment)
measure: Modified Fatigue Impact Scale
timeFrame: Week 1 (at baseline)
measure: Modified Fatigue Impact Scale
timeFrame: Week 4 (after 8th treatment)
measure: Cognitive Processing Speed
timeFrame: Week 1 (at baseline)
measure: Cognitive Processing Speed
timeFrame: Week 4 (after 8th treatment)
measure: Short-form McGill Pain Questionnaire
timeFrame: Week 1 (at baseline)
measure: Short-form McGill Pain Questionnaire
timeFrame: Week 4 (after 8th treatment)
measure: Hospital Anxiety Depression Scale
timeFrame: Week 1 (at baseline)
measure: Hospital Anxiety Depression Scale
timeFrame: Week 4 (after 8th treatment)
measure: Insomnia Severity Index
timeFrame: (Week 1 (at baseline)
measure: Insomnia Severity Index
timeFrame: Week 4 (after 8th treatment)
measure: Nine-Hole Peg Test
timeFrame: Week 1 (at baseline)
measure: Nine-Hole Peg Test
timeFrame: Week 4 (after 8th treatment)
measure: Timed 25 foot Walk Test
timeFrame: Week 1 (at baseline)
measure: Timed 25 foot Walk Test
timeFrame: Week 4 (after 8th treatment)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: William R Reed, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References: