Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease
Fibromyalgia

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Peak Expiratory Flow and Thoracic Mobility in People With Fibromyalgia. A Cross Sectional Study.
Actual Study Start Date : January 1, 2008
Actual Primary Completion Date : July 31, 2008
Actual Study Completion Date : December 31, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia




Primary Outcome Measures :
  1. Peak expiratory flow [ Time Frame: Day 1 ]
    maximum airflow achieved during expiration delivered with maximal force starting from the level of maximal lung inflation

  2. 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.

  3. Spinal mobility [ Time Frame: Day 1 ]
    Measure flexion mobility in the upper thoracic spine (C7-T5) by using the Cervico thoracic ratio method.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Female patients with diagnosed fibromyalgia and female healthy subjects included as controls.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495687


Locations
Layout table for location information
Sweden
Uppsala university
Uppsala, Sweden, SE-75185
Sponsors and Collaborators
Uppsala University
Sormland County Council, Sweden
Investigators
Layout table for investigator information
Principal Investigator: Magnus Peterson, MD PhD Uppsala University
Layout table for additonal information
Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03495687    
Other Study ID Numbers: uppsala17
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uppsala University:
Respiratory function
Spinal mobility
Chest expansion
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases