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FibromyalgiaNCT04098731

Evaluation of Respiratory Function in Fibromyalgia

An observational study of Fibromyalgia and Respiratory Alkalosis and Metabolic Acidosis, 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

This study will evaluate respiratory function in people with fibromyalgia and whether or not breathing patterns in this patient group can be explained by stress, emotional or biomechanical variables. In addition, examine the relationship between physical ability and lactate values. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
How many people
90 participants
Where
1 siteSweden
Study dates
28 Jun 2018to 1 Feb 2022
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
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with diagnosed fibromyalgia and healthy subjects included as controls.

Who may be able to join

  • Male or female with fibromyalgia according to American College of Rheumatology criteria 2010.
  • Age 20 to 65 years
  • Informed consent.

Who cannot join

  • Trauma in neck-shoulder or thoracic region with prolonged symptoms during the last three months 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 in Swedish
  • Use of antidepressant drugs
  • For the healthy controls, any other complaints from the chest wall and neck and shoulder region within three month before examination.
  • N.B Smoking will not be an exclusion criterion.

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Nyköping hospital

    Nyköping, Sörmland, 61185

Other trials in Sweden

About this study

Official title: Evaluation of Respiratory Function in People With Fibromyalgia

This study will evaluate respiratory function in people with fibromyalgia and whether or not breathing patterns in this patient group can be explained by stress, emotional or biomechanical variables. In addition, examine the relationship between physical ability and lactate values.

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 people with fibromyalgia and compare with age-matched controls.

Respiratory function will be examined by spirometry and blood gases. Both static (vital capacity, tidal volume) and dynamic lung volumes (forced vital capacity, forced expiratory volume in 1 second) and the ratio of forced expiratory volume in 1 second and forced vital capacity will be used. Spirometry will be performed in seated position. Respiratory rate will be examined in a sitting position using intensive care equipment with electrodes placed under each clavicle and over the lower ribs on the left side. After five minutes of relaxing, breathing frequency is observed during one minute. A value is noted every ten second and a mean value is calculated. Subjects are not aware of when the observation begin. An arterial blood sample will be taken to determine carbon dioxide, oxygen, saturation, bicarbonate, pH and base excess levels. Other blood samples that will be taken is magnesium in venous blood and lactate in capillary blood. Arterial and venous blood samples will be taken in supine position while capillary samples will be done in seated position. Lactate will be sampled before and directly after a six minutes walking test.

Chest mobility, postural balance, spinal mobility, pain sensitivity test and body mass index will be measured as physical or biomechanical variables. By using a tape measure chest mobility will be measured in a standing position at the xiphoid process and axillary level. Spinal mobility will be measured in a seated position between C7-T5 measuring the difference between upright position and full flexion of the spine. By using an analyzing software program called Cervico thoracic ratio 5.0, postural balance can be calculated based on the same method of measuring spinal mobility described above. Pain sensitivity test will be performed over paraspinal muscles between the level of C7-T7 with a total of 14 locations by using a pressure algometer with the subject lying prone. Measurement of the subject's weight and height will be recorded and the body mass index (BMI) will be calculated.

Heart rate variability and self administered questionnaires (Hospital and anxiety depression scale, Pain catastrophizing scale, Perceived stress scale, Montgomery-Asberg Depression Rating Scale) will be used to assess stress or emotional variables. The Rand 36-item will be used as a quality-of-life measurement. Heart rate variability will be measured during five minutes by a portable ECG device in a sitting position with electrodes placed under each clavicle and over the lower ribs on the left side. Questionnaires are encouraged to be filled in before the visit.

For physical function a standardized six minutes walking test and a chair stand test will take place for measuring endurance and strength.

All measurement will be executed at the same visit. Data about smoking habits, pain duration, analgetic drug use will be registered.

Keywords
Fibromyalgia, Respiratory function
Medical subject headings
Fibromyalgia, Alkalosis, Respiratory, Acidosis, Respiratory Aspiration

What is being measured

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

  1. Forced expiratory volume in percentage (FEV%)

    The forced expiratory volume in percentage will be determined by the ratio of the forced expiratory volume in one second (L/sec) and the forced vital capacity (L). A spirometer is used for these respiratory tests.

    Measured: Day 1

  2. Partial pressure of carbon dioxide

    An arterial (radial) blood gas test will be performed to measure the carbon dioxide partial pressure (kPa).

    Measured: Day 1

Secondary outcomes (1)
  1. Respiratory rate

    Respiratory rate is the number of breaths a person take per minute (number per minute). Respiratory rate will be measured by using intensive care equipment. Electrodes will be placed under each clavicle and over the lower ribs on the left side. The equipment sense the distance between the electrodes i.e the movement of the chest wall. After five minutes of relaxing, respiratory rate is measured during one minute.

    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 posted23 Sep 2019
  2. Study start28 Jun 2018
  3. Primary completion1 Feb 2022
  4. Study completion1 Feb 2022

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
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04098731
Sponsor's protocol ID
uppsala18
Status last verified
Mar 2022
First submitted
20 Aug 2019
Last updated
21 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jonsson K, Pikwer A, Olsson EM, Peterson M. Altered breathing pattern and thoracic mobility in women with fibromyalgia: A case-control study. J Pain. 2025 Oct;35:105508. doi: 10.1016/j.jpain.2025.105508. Epub 2025 Jul 22.

    PubMed 40706939

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia and Respiratory Alkalosis and Metabolic Acidosis, 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 6 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 21 Mar 2022. 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?

Forced expiratory volume in percentage (FEV%) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04098731, which also lists 1 linked publication.

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 21 Mar 2022.

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