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FibromyalgiaNCT03495687

Breathing and Chest Wall Mobility in People With Fibromyalgia.

An observational study of Fibromyalgia, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fibromyalgia
How many people
82 participants
Where
1 siteSweden
Study dates
1 Jan 2008to 31 Dec 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Uppsala university

    Uppsala, SE-75185

Other trials in Sweden

About this study

Official title: Peak Expiratory Flow and Thoracic Mobility in People With Fibromyalgia. A Cross Sectional Study.

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.

Read the detailed description

Fibromyalgia is characterized by persistent widespread pain and affects approximately 1-3% of the general population. Fibromyalgia is a multifactorial syndrome and much research has been done and several interesting facts discovered. Still, the etiology is unknown. The autonomic nervous system may be the cause of several symptoms of this condition and a pattern of abnormal autonomous functions has been described . Besides the autonomous nerve system the respiratory system has also potential to impact various body organs mainly by altered blood gas chemistry. Deviant respiratory function in local pain condition as in cervical and lumbar spine has been reported. Respiratory function in generalized pain as in people with fibromyalgia has not been given much consideration.

This project is an observational cross sectional study with the purpose to examine respiratory function in a group of females with fibromyalgia and compare with age-matched controls. Peak expiratory flow (PEF), Chest mobility, spinal mobility and pain palpation where measured at the same visit. Data about smoking habits was registered and in patients also the duration of pain. Measurement of the subject's weight and height were recorded and the body mass index (BMI) was calculated. For evaluation of forced exhalation, a Wright peak expiratory flow meter was used. PEF was measured three times and the best result was recorded. Spinal mobility was measured by using the Cervico-thoracic ratio (CTR) method. The CTR measure was done in a sitting position with the subject instructed to sit in an upright posture and look straight in front of them. The spinous process of the seventh cervical vertebra (C7) was palpated as the referent point and a mark was made on the vertex followed by marks for each motion segment between C7 to the fifth thoracic vertebra (T5) by using a CTR measuring strip. Then the subjects were told to flex the chin and the trunk forward as much as possible. Again, the distance between C7 and T5 was measured and the difference between measurements in upright position and maximum flexed position was calculated in mm for each segment to a total sum for all segments from C7-T5. A tape measure was used to measure the mobility of the thorax at maximum inhalation and exhalation at the level of proc. Xiphoideus. Every measurement was performed three times and the best measurement was recorded. Manual palpation for pain was done over the upper thoracic spine in the same area as the spinal mobility was measured, with subjects lying prone on an examination table. A total of 20 locations were palpated from C7 to T5. First left side facets, and then left side costotransverse joints in the same segmental level. The same procedure was then used for the right side. Palpation was done with a force of approximately 4kg/sq cm (equating to blanching of the thumb or fingernail). After each point was palpated the subject estimated perceived pain on a visual analogue scale.

A ratio was also constructed by PEF (l / min) / chest expansion (cm) called expiratory-inspiratory ratio.

Conditions
Fibromyalgia
Keywords
Respiratory function, Spinal mobility, Chest expansion
Medical subject headings
Fibromyalgia, Respiratory Aspiration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak expiratory flow

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

    Measured: Day 1

  2. 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.

    Measured: Day 1

  3. Spinal mobility

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

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2018
  2. Study start1 Jan 2008
  3. Primary completion31 Jul 2008
  4. Study completion31 Dec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03495687
Sponsor's protocol ID
uppsala17
Status last verified
Apr 2018
First submitted
13 Mar 2018
Last updated
12 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak expiratory flow (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.

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