NCT03495687

Brief Summary

The aim of this study is to examine differences between respiratory function in female fibromyalgia patients and healthy controls. The study will also examine differences in spine mobility and pain intensity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2008

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

March 13, 2018

Last Update Submit

April 4, 2018

Conditions

Fibromyalgia

Keywords

Respiratory functionSpinal mobilityChest expansion

Outcome Measures

Primary Outcomes (3)

  • Peak expiratory flow

    maximum airflow achieved during expiration delivered with maximal force starting from the level of maximal lung inflation

    Day 1

  • Chest expansion

    measures the thoracic circumference at the end of forced inspiration minus thoracic circumference at the end of forced expiration with a tape measure in the level of proc. xiphoideus.

    Day 1

  • Spinal mobility

    Measure flexion mobility in the upper thoracic spine (C7-T5) by using the Cervico thoracic ratio method.

    Day 1

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients with diagnosed fibromyalgia and female healthy subjects included as controls.

You may qualify if:

  • Female diagnosed fibromyalgia according to American College of Rheumatology 1990 criteria
  • Age 20-65 years
  • Informed consent

You may not qualify if:

  • trauma in neck-shoulder or thoracic region with prolonged symptoms during the last three month before examination
  • severe illness (neurological e.g Parkinson disease, neuromuscular e.g Multiple sclerosis, respiratory e.g chronic obstructive pulmonary disease, muscle/skeletal disease e.g ankylosing spondylitis)
  • Inability to understand or follow instructions
  • Inability to participate at measurement sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala university

Uppsala, SE-75185, Sweden

Location

MeSH Terms

Conditions

FibromyalgiaRespiratory Aspiration

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Magnus Peterson, MD PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2018

First Posted

April 12, 2018

Study Start

January 1, 2008

Primary Completion

July 31, 2008

Study Completion

December 31, 2008

Last Updated

April 12, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)