ME/CFS, Hypermobility and Craniocervical Obstructions

May 21, 2020 updated by: Bragee Clinics

Hypermobility and Obstructions in the Craniocervical Region Among Patients With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11526
        • Bragee Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

190 women 39 men Mean duration 9 years

Description

Inclusion Criteria:

Patients at a multidisciplinary specialist clinic accepting to participate

Exclusion Criteria:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of cervical obstruction and other MRI findings
Time Frame: 1990-2020
Findings as disc bulging, disc hernias, chiari malformations
1990-2020
Prevalence of hypermobility
Time Frame: 1990-2020
Measured as Beighton score and other signs of Ehlers Danlos syndrome (EDS) variations
1990-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bragee Clinics

Collaborators

Karolinska Institutet

Investigators

  • Study Director: Björn Bragée, MD, Bragee Clinics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Meret2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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