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Breathing and Chest Wall Mobility in People With Fibromyalgia.

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. Identifier: NCT03495687
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sormland County Council, Sweden
Information provided by (Responsible Party):
Uppsala University

Tracking Information
First Submitted Date March 13, 2018
First Posted Date April 12, 2018
Last Update Posted Date April 12, 2018
Actual Study Start Date January 1, 2008
Actual Primary Completion Date July 31, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2018)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Breathing and Chest Wall Mobility in People With Fibromyalgia.
Official Title Peak Expiratory Flow and Thoracic Mobility in People With Fibromyalgia. A Cross Sectional Study.
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Female patients with diagnosed fibromyalgia and female healthy subjects included as controls.
Condition Fibromyalgia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 4, 2018)
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2008
Actual Primary Completion Date July 31, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: Female
Ages 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
Administrative Information
NCT Number NCT03495687
Other Study ID Numbers uppsala17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Uppsala University
Study Sponsor Uppsala University
Collaborators Sormland County Council, Sweden
Principal Investigator: Magnus Peterson, MD PhD Uppsala University
PRS Account Uppsala University
Verification Date April 2018