FibromyalgiaNCT03495687
Breathing and Chest Wall Mobility in People With Fibromyalgia.
An observational study of Fibromyalgia, run by Uppsala University at 1 site in Sweden.
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.
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.
Peak expiratory flow
maximum airflow achieved during expiration delivered with maximal force starting from the level of maximal lung inflation
Measured: 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.
Measured: Day 1
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.
- First posted12 Apr 2018
- Study start1 Jan 2008
- Primary completion31 Jul 2008
- Study completion31 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Sormland County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Magnus Peterson, MD PhD, Principal investigator, Uppsala University
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peak Expiratory Flow and Thoracic Mobility in People With Fibromyalgia. A Cross Sectional Study.
- ClinicalTrials.gov ID
- NCT03495687
- Acronym / sponsor ID
- uppsala17
- Conditions
- Fibromyalgia
- Keywords
- Respiratory function, Spinal mobility, Chest expansion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Sormland County Council, Sweden
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Jul 2008 (actual)
- Study completion
- 31 Dec 2008 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with diagnosed fibromyalgia and female healthy subjects included as controls.
Key inclusion criteria (3 listed)
- Female diagnosed fibromyalgia according to American College of Rheumatology 1990 criteria
- Age 20-65 years
- Informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peak expiratory flow
Time frame: Day 1
maximum airflow achieved during expiration delivered with maximal force starting from the level of maximal lung inflation
Chest expansion
Time frame: Day 1
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.
Spinal mobility
Time frame: Day 1
Measure flexion mobility in the upper thoracic spine (C7-T5) by using the Cervico thoracic ratio method.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Peterson, MD PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
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.