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Behavioural Intervention
Chiropractic Care for Multiple Sclerosis
N/A
Recruiting
Led By William R Reed, DC, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 to 55 years
No known cardiovascular, pulmonary, or metabolic disease
Must not have
Any past spinal surgery or recent history of bone fractures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4 (after 8th treatment)
Summary
This trial will test the effects of spinal manipulation on pro- and anti-inflammatory markers in people with MS.
Who is the study for?
This trial is for adults aged 18-55 with a recent diagnosis of relapsing-remitting Multiple Sclerosis (MS), who are stable on FDA-approved MS medications, and have not had an MS flare-up in the past month. They should be new to chiropractic care, free from major diseases or conditions that affect the heart, lungs, or metabolism, and must not have had spinal surgery or bone fractures recently.
What is being tested?
The study tests if chiropractic care can influence immune markers in people with MS. Participants will receive either real spinal manipulation treatments or sham (fake) ones over four weeks to see how their cytokine levels change immediately after treatment and cumulatively.
What are the potential side effects?
While specific side effects aren't listed for this trial, typical risks of spinal manipulation may include temporary discomfort at the site of adjustment, headaches, fatigue, and rarely more serious complications like herniated disks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
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I do not have any known heart, lung, or metabolic diseases.
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I can safely undergo spinal manipulation.
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My disability score is below 4, indicating I can walk without aid or rest for 500m.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had spinal surgery or recent bone fractures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4 (after 8th treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4 (after 8th treatment)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Serum inflammatory cytokine levels
Secondary study objectives
Cognitive Processing Speed
Fatigue Severity Scale
Hospital Anxiety Depression Scale
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Spinal ManipulationExperimental Treatment1 Intervention
The spinal manipulation (SM) group will receive manually delivered SM limited to the thoracic spine.
Group II: Sham Spinal ManipulationPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,360 Total Patients Enrolled
38 Trials studying Multiple Sclerosis
45,339 Patients Enrolled for Multiple Sclerosis
William R Reed, DC, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 55 years old.You have not received chiropractic care before.Your blood pressure is very high and not controlled with medication.I have not had a relapse in the last 30 days.I am on a stable, FDA-approved treatment for my condition.I do not have any known heart, lung, or metabolic diseases.I can safely undergo spinal manipulation.I was diagnosed with MS in the last 5 years.My disability score is below 4, indicating I can walk without aid or rest for 500m.I have had spinal surgery or recent bone fractures.You were pregnant in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Spinal Manipulation
- Group 2: Sham Spinal Manipulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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