Effects of Chiropractic Care on Cytokine Levels in Multiple Sclerosis

NCT04972929 | Completed

• 2 other identifiers: IRB-300007021TRG2020
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

chiropractic; spinal manipulation; multiple sclerosis; cytokines

Outcome Measures

Primary Outcomes (3)

• Serum inflammatory cytokine levels

  Determine changes in serum inflammatory cytokine levels from baseline

  Week 1 (at baseline)

• Serum inflammatory cytokine levels

  Determine changes in serum inflammatory cytokine levels from baseline

  Week 1 (after 1st treatment

• Serum inflammatory cytokine levels

  Determine changes in serum inflammatory cytokine levels from baseline

  Week 4 (after 8th treatment)

Secondary Outcomes (16)

• Fatigue Severity Scale

  Week 1 (at baseline)

• Fatigue Severity Scale

  Week 4 (after 8th treatment)

• Modified Fatigue Impact Scale

  Week 1 (at baseline)

• Modified Fatigue Impact Scale

  Week 4 (after 8th treatment)

• Cognitive Processing Speed

  Week 1 (at baseline)

Study Arms (2)

Spinal Manipulation

EXPERIMENTAL

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

Other: Spinal Manipulation

Sham Spinal Manipulation

SHAM COMPARATOR

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

Interventions

Spinal Manipulation OTHER

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).

Also known as: chiropractic care

Spinal Manipulation

Sham Spinal Manipulation OTHER

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.

Sham Spinal Manipulation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• William R Reed, DC, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: e plan to conduct a randomized pilot parallel-group randomized controlled trial (RCT) with appropriate SM and Sham SM treatment groups.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: July 22, 2021
• Study Start: December 15, 2022
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)