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.
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
- Conditions the study is for
- Fibromyalgia, Respiratory Alkalosis and Metabolic Acidosis, Chronic Hyperventilation
- 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.
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.
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
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)
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.
- First posted23 Sep 2019
- Study start28 Jun 2018
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magnus Peterson, MD PhD, Principal investigator, Uppsala University
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respiratory Function in People With Fibromyalgia
- ClinicalTrials.gov ID
- NCT04098731
- Acronym / sponsor ID
- uppsala18
- Keywords
- Fibromyalgia, Respiratory function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 23 Sep 2019 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed fibromyalgia and healthy subjects included as controls.
Key inclusion criteria (3 listed)
- Male or female with fibromyalgia according to American College of Rheumatology criteria 2010.
- Age 20 to 65 years
- Informed consent.
Key exclusion criteria (6 listed)
- 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.
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
Forced expiratory volume in percentage (FEV%)
Time frame: Day 1
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.
Partial pressure of carbon dioxide
Time frame: Day 1
An arterial (radial) blood gas test will be performed to measure the carbon dioxide partial pressure (kPa).
1 secondary outcome
Respiratory rate
Time frame: Day 1
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 21 Mar 2022.
- Derived from this study: PubMed 40706939Jonsson 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.
Related trials for Fibromyalgia
Not yet recruitingObservational study
Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome
Fibromyalgia Syndrome
Active, not recruiting
Comparing Instrument-Assisted Soft Tissue Mobilization and Muscle Energy Technique for Myofascial Pain Syndrome in Women
Myofascial Pain Syndrome
Not yet recruitingObservational study
Daily Cognitive Failures and Medication Adherence in Fibromyalgia
Fibromyalgia
Not yet recruiting
Toward Biomarker-Guided Fibromyalgia Treatment With Non-Invasive Vagus Nerve Stimulation
Fibromyalgia
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
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 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.