ClinicalTrials.gg
CompletedNCT04098731Updated Mar 21, 2022

Evaluation of Respiratory Function in Fibromyalgia

An observational study in Fibromyalgia, Respiratory Alkalosis and Metabolic Acidosis and Chronic Hyperventilation, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-21.

Sponsored by Uppsala University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
90
Ages
20 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 32 studies in Fibromyalgia with a site in Sweden — 2 open to participants now, 5 under way, none of them phase 3. Fibromyalgia · Sweden.

Started
2018
the only one that year
Observational
9 of 32
1 open now
Registered
21st of 32
by date
Lead sponsor
6 of 32
Uppsala University

Among the 32 studies in Fibromyalgia with a site in Sweden, this one is the only one that started in 2018, is one of 9 observational ones, and was the 21st registered.

Fibromyalgia

1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.

Browse Fibromyalgia studies →

Open to participants now

2 of the 32 studies in Fibromyalgia with a site in Sweden are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →

Who these studies take

Of the 160 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 96 (60%) stop at 75 or younger; 14 take children under 18; 35 take healthy volunteers.

This study: 20 Years to 65 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study 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 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.

03

Conditions studied

  • Fibromyalgia
  • Respiratory Alkalosis and Metabolic Acidosis
  • Chronic Hyperventilation

Keywords

  • Fibromyalgia
  • Respiratory function
04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with diagnosed fibromyalgia and healthy subjects included as controls.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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 , 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
90 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  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.

    Time frame: 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).

    Time frame: Day 1

Secondary outcomes

  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.

    Time frame: Day 1

07

Study locations

1 site
  • Nyköping hospital
    Nyköping, Sörmland 61185, Sweden
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2018 to primary completion in Feb 2022, 43 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2019
First posted
Sep 23, 2019
StartActual
Jun 28, 2018
Primary completionActual
Feb 1, 2022
CompletionActual
Feb 1, 2022
Last update
Mar 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04098731
Lead sponsor
Uppsala University
Responsible party
Sponsor
First posted
Sep 23, 2019
Start date
Jun 28, 2018
Primary completion
Feb 1, 2022
Completion
Feb 1, 2022
Last update
Mar 21, 2022

Study contacts

Magnus Peterson, MD PhD
principal investigator · Uppsala University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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