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ME/CFS, Hypermobility and Craniocervical Obstructions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399330
Recruitment Status : Completed
First Posted : May 22, 2020
Last Update Posted : May 26, 2020
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Bragee Clinics

Brief Summary:
A retrospective study on clinical and radiological findings in ME/CFS

Condition or disease
Chronic Fatigue Syndrome

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Study Type : Observational
Actual Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Hypermobility and Obstructions in the Craniocervical Region Among Patients With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prevalence of cervical obstruction and other MRI findings [ Time Frame: 1990-2020 ]
    Findings as disc bulging, disc hernias, chiari malformations

  2. Prevalence of hypermobility [ Time Frame: 1990-2020 ]
    Measured as Beighton score and other signs of Ehlers Danlos syndrome (EDS) variations



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
190 women 39 men Mean duration 9 years
Criteria

Inclusion Criteria:

Patients at a multidisciplinary specialist clinic accepting to participate

Exclusion Criteria:

none


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): NCT04399330


Locations
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Sweden
Bragee Clinics
Stockholm, Sweden, 11526
Sponsors and Collaborators
Bragee Clinics
Karolinska Institutet
Investigators
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Study Director: Björn Bragée, MD Bragee Clinics
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Responsible Party: Bragee Clinics
ClinicalTrials.gov Identifier: NCT04399330    
Other Study ID Numbers: Meret2019
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Syndrome
Fatigue
Disease
Pathologic Processes
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases