FibromyalgiaNCT06396949

The Relationship Between Diaphragm Muscle Thickness and Fibromyalgia

An observational study of Fibromyalgia and Anxiety, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Fibromyalgia syndrome is characterized by chronic pain, fatigue, sleep problems and functional symptoms. Fatigue, anxiety and depression disorders, poor quality of life, sleep disorders, decreased concentration, and impaired cognitive functions are non-specific pain-related symptoms. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Fibromyalgia, Anxiety, Depression
What is being tested?: Fibromyalgia study form, Pulmonary function test and Ultrasonographic Diaphragm Thickness Measurement
How many people: 45 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Dec 2023to 30 May 2024
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 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Study population: It will consist of participants with fibromyalgia patients, according to the 2016 ACR (American College of Rheumatology) diagnostic criteria, who apply to the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences Gaziosmanpasa Training and Research Hospital within the study date ranges, meet the inclusion and exclusion criteria and voluntarily agree to participate in the research. Healthy individuals identical in age and gender will be included in the study as a control group. Demographic information (Fibromyalgia study form, consisting of clinical measurement, Fibromyalgia impact questionnaire (FIQ), Beck Anxiety Questionnaire and Beck Depression Questionnaire, Short-Form (SF)-36, ) of all individuals involved in the recruitment will be collected.

Who may be able to join

Patients diagnosed with fibromyalgia according to the 2016 ACR (American College of Rheumatology) diagnostic criteria without any comorbidities (such as liver, kidney failure, DM, rheumatic disease)
Patients who underwent Pulmonary Function Test (PFT)
Patients without pulmonary disease
18 -50 years old women and men

Who cannot join

Congenital spinal, costal and diaphragmatic anomalies neuromuscular disease
Respiratory system diseases that affect lung functions
Patients who cannot cooperate with spirometry.
Having surgery to the chest wall or spine
Those with BMI > 25
Those with liver, kidney failure, DM, rheumatic disease, neurological disease
Individuals < 18 years and > 50 years old

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Deniz Oke
Istanbul, Gaziosmanpasa, 34255

Other trials in Turkey (Türkiye)

About this study

Official title: The Relationship Between Diaphragm Muscle Thickness and Anxiety, Depression and Activities of Daily Living in Fibromyalgia Patients

Various studies have reported decreased chest expansion, maximal ventilatory volume and maximal expiratory pressure in fibromyalgia patients with widespread body pain. Additionally, dyspnea is a symptom associated with respiratory muscle weakness and is associated with general fatigue. In these individuals, lower data are obtained in daily living activities and general health evaluation surveys. We did not find any study in the literature regarding the relationship between diaphragm thickness and fibromyalgia symptoms. In the light of these data, we aimed to evaluate the thickness of the diaphragm, one of the most important inspiratory muscles, in fibromyalgia patients.

Read the detailed description

Demographic information of all individuals included in the study will be collected. Daily living activity will be evaluated with Short Form-36 (SF-36), Fibromyalgia Impact Questionnaire (FIQ), Pittsburgh Sleep Quality Questionnaire (PSQI) and Beck Depression Inventory. In order to evaluate the respiratory function test in both the fibromyalgia and control groups, three consecutive measurements will be taken with a hand spirometer and the arithmetic average of these three measurements will be recorded. In fibromyalgia and control patients, diaphragm thickness was measured at 8-9 degrees on the right anterior axillary line with a 6-14 Mhz linear, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD., P.R. China) in the supine position. It will be measured at the end of inspiration and expiration from the intercostal space. Three measurements will be made and the arithmetic average will be evaluated.

Conditions: Fibromyalgia, Anxiety, Depression, Diaphragm Issues
Being tested: Fibromyalgia study form, Pulmonary function test, Ultrasonographic Diaphragm Thickness Measurement
Keywords: Diaphragm thickness, Activities of daily living
Medical subject headings: Fibromyalgia, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fibromyalgia study formDiagnostic test
Fibromyalgia study form, consisting of clinical measurement, Fibromyalgia impact questionnaire (FIQ), Beck Anxiety Questionnaire and Beck Depression Questionnaire, Short-Form (SF)-36, who applied to the outpatient clinic with fibromyalgia will be filled in detail.
Pulmonary function testDiagnostic test
Also called Spirometry function test
Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders.
The investigators will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.
Ultrasonographic Diaphragm Thickness MeasurementDiagnostic test
Diaphragm thickness (millimeter-mm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (millimeter-mm), end-inspiratory (Total Lung Capacity) (millimeter-mm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken.

Study groups in NCT06396949
Study group	Role	What they receive
Patient group		Volunteer men and women diagnosed with fibromyalgia to ACR (American College of Rheumatology) 2016 criteria between the ages of 18 and 50 who applied to our clinic will be included in our study Receives: Diagnostic Test: Fibromyalgia study form; Diagnostic Test: Pulmonary function test; Diagnostic Test: Ultrasonographic Diaphragm Thickness Measurement
Control group		Healthy,volunteer men and women between the ages of 18-50 who applied to our clinic will be included in our study Receives: Diagnostic Test: Fibromyalgia study form; Diagnostic Test: Pulmonary function test; Diagnostic Test: Ultrasonographic Diaphragm Thickness Measurement

What is being measured

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

Fibromyalgia study form
Fibromyalgia study form, consisting of clinical measurement (2016 ACR (American College of Rheumatology) fibromyalgia diagnostic criteria, Fibromyalgia impact questionnaire (FIQ), Beck Anxiety Questionnaire and Beck Depression Questionnaire, Short-Form (SF)-36), who applied to the outpatient clinic with fibromyalgia will be filled in detail.
Measured: Within 1 month of applying to the outpatient clinic
Pulmonary function test
The investigators will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.
Measured: Within 1 month of applying to the outpatient clinic
Ultrasonographic Diaphragm Thickness Measurement
Diaphragm thickness (millimeter-mm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (millimeter-mm), end-inspiratory (Total Lung Capacity) (millimeter-mm) and thickening rate (%) (thickness TLC / thickness FRC) (percentage) will be evaluated three times and the arithmetic average of these three measurements will be taken.
Measured: Within 1 month of applying to the outpatient clinic
Fibromyalgia diagnostic criteria
2016 revised American College of Rheumatology fibromyalgia diagnostic criteria; A patient satisfies the modified 2016 fibromyalgia criteria if the following three conditions are met:
1. Widespread pain index (WPI) ≥7 and symptom severity scale (SSS) score ≥5, or WPI of 4∼6 and SSS score ≥9. 2. Generalized pain, defined as pain in at least four of five regions, must be present. Jaw, chest, and abdominal pain are excluded from the generalized pain definition. 3. Symptoms have been generally present for at least 3 months. 4. A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses.
Measured: Within 1 month of applying to the outpatient clinic
Fibromyalgia diagnostic criteria-Widespread pain index (WPI)
Ascertainment
1. WPI: note the number of areas in which the patient has had pain over the past week. In how many areas has the patient had pain? Score will be between 0 and 19 (Region 1) (Left upper region); jaw, left shoulder girdle, left upper arm, left lower arm, (Region 2) (Right upper region); jaw, right shoulder girdle, right upper arm, right lower arm, (Region 3) (Left lower region); hip (buttock, trochanter), left upper leg, left lower leg, (Region 4) (Right lower region); hip (buttock, trochanter), right upper leg, right lower leg and (Region 5) (Axial region); neck, upper back, lower back, chest, abdomen
Measured: Within 1 month of applying to the outpatient clinic
Fibromyalgia diagnostic criteria-Symptom severity scale (SSS)
1. SSS score Fatigue Waking unrefreshed Cognitive symptoms For each of the three symptoms above, indicate the level of severity over the past week using the following scale: 0=no problem 1=slight or mild problems, generally mild or intermittent 2=moderate, considerable problems, often present and/or at a moderate level 3=severe: pervasive, continuous, life-disturbing problems The SSS score is the sum of the severity scores of the three symptoms (fatigue, waking unrefreshed, and cognitive symptoms) (0∼9), plus the sum (0∼3) of the number of the following symptoms the patient has been bothered by that occurred during the previous 6 months: 1.Headaches (0∼1) 2. Pain or cramps in lower abdomen (0∼1) 3. Depression (0∼1). The final symptom severity score is between 0 and 12 The fibromyalgia severity scale is the sum of the WPI and SSS
Measured: Within 1 month of applying to the outpatient clinic

Secondary outcomes (4)

Fibromyalgia Impact Questionnaire
The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. The FIQ is composed of 10 items. The first item contains 11 questions related to physical functioning - each question is rated on a 4 point Likert type scale. Items 2 and 3 ask the patient to mark the number of days they felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression. The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.
Measured: Within 1 month of applying to the outpatient clinic
Beck Anxiety Inventory
The BAI is a rating scale used to evaluate the severity of anxiety symptoms. The scale was developed by Aaron T Beck, MD.The BAI contains 21 self-report items. The items reflect symptoms of anxiety, including: numbness or tingling, feeling hot, wobbliness in legs, ability to relax, fear of the worst happening, dizziness or lightheadedness, pounding or racing heart, unsteadiness, feeling terrified, feeling nervous, feeling of choking, hands trembling, feeling shaky, fear of losing control, difficulty breathing, fear of dying, feeling scared, indigestion or abdominal discomfort, faintness, face flushing, and sweating. Each item allows the patient four choices from no symptom to severe symptom. For each item, the patient is asked to report how he or she has felt during the past week. The items are scored as 0, 1, 2, or 3. The score range is 0-63. A total score of 0-7 is considered minimal range, 8-15 is mild, 16-25 is moderate, and 26-63 is severe.
Measured: Within 1 month of applying to the outpatient clinic
Beck Depression Inventory
The Beck Depression Inventory (BDI) is a 21-item, self-rated scale that evaluates key symptoms of depression including mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, crying, irritability, social withdrawal, indecisiveness, body image change, work difficulty, insomnia, fatigability, loss of appetite, weight loss, somatic preoccupation, and loss of libido. Individual scale items are scored on a 4-point continuum (0=least, 3=most), with a total summed score range of 0-63. Higher scores indicate greater depressive severity
Measured: Within 1 month of applying to the outpatient clinic
Short Form- 36 (SF-36)
The SF-36 is a health status profile originally designed to measure health status of patients and outcomes of patients.The 36 questions on the SF-36 are meant to reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social function, emotional role, and mental health. The categories of physical role and emotional role reflect performance at the activity and participation levels.To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Measured: Within 1 month of applying to the outpatient clinic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202330 May 2024

First posted2 May 2024
Study start15 Dec 2023
Primary completion30 May 2024
Study completion30 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)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: Prospective
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06396949
Sponsor's protocol ID: 97
Status last verified: Jan 2025
First submitted: 11 Jan 2024
Last updated: 28 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
PubMed 20461783
Sarzi-Puttini P, Giorgi V, Atzeni F, Gorla R, Kosek E, Choy EH, Bazzichi L, Hauser W, Ablin JN, Aloush V, Buskila D, Amital H, Da Silva JAP, Perrot S, Morlion B, Polati E, Schweiger V, Coaccioli S, Varrassi G, Di Franco M, Torta R, Oien Forseth KM, Mannerkorpi K, Salaffi F, Di Carlo M, Cassisi G, Batticciotto A. Fibromyalgia position paper. Clin Exp Rheumatol. 2021 May-Jun;39 Suppl 130(3):186-193. doi: 10.55563/clinexprheumatol/i19pig. Epub 2021 May 13.
PubMed 34001303
Alciati A, Nucera V, Masala IF, Giallanza M, La Corte L, Giorgi V, Sarzi-Puttini P, Atzeni F. One year in review 2021: fibromyalgia. Clin Exp Rheumatol. 2021 May-Jun;39 Suppl 130(3):3-12. doi: 10.55563/clinexprheumatol/gz4i3i. Epub 2021 May 13.
PubMed 34001307
Ortiz-Rubio A, Torres-Sanchez I, Cabrera-Martos I, Lopez-Lopez L, Rodriguez-Torres J, Granados-Santiago M, Valenza MC. Respiratory disturbances in fibromyalgia: A systematic review and meta-analysis of case control studies. Expert Rev Respir Med. 2021 Sep;15(9):1217-1227. doi: 10.1080/17476348.2021.1918547. Epub 2021 Apr 26.
PubMed 33857393
Tomas-Carus P, Biehl-Printes C, Del Pozo-Cruz J, Parraca JA, Folgado H, Perez-Sousa MA. Effects of respiratory muscle training on respiratory efficiency and health-related quality of life in sedentary women with fibromyalgia: a randomised controlled trial. Clin Exp Rheumatol. 2022 Jun;40(6):1119-1126. doi: 10.55563/clinexprheumatol/0v55nh. Epub 2022 Jun 22.
PubMed 35748715
Noda Y, Sekiguchi K, Kohara N, Kanda F, Toda T. Ultrasonographic diaphragm thickness correlates with compound muscle action potential amplitude and forced vital capacity. Muscle Nerve. 2016 Apr;53(4):522-7. doi: 10.1002/mus.24902. Epub 2015 Oct 10.
PubMed 26357011

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Relationship Between Diaphragm Muscle Thickness and Anxiety, Depression and Activities of Daily Living in Fibromyalgia Patients
ClinicalTrials.gov ID: NCT06396949
Acronym / sponsor ID: 97
Conditions: Fibromyalgia, Anxiety, Depression, Diaphragm Issues
Keywords: Diaphragm thickness, Activities of daily living
Study type: Observational
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Gaziosmanpasa Research and Education HospitalOther government
Study start: 15 Dec 2023 (actual)
Primary completion: 30 May 2024 (actual)
Study completion: 30 May 2024 (actual)
First posted: 2 May 2024 (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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Patient group	–	Diagnostic Test: Fibromyalgia study form, Diagnostic Test: Pulmonary function test, Diagnostic Test: Ultrasonographic Diaphragm Thickness MeasurementVolunteer men and women diagnosed with fibromyalgia to ACR (American College of Rheumatology) 2016 criteria between the ages of 18 and 50 who applied to our clinic will be included in our study
Control group	–	Diagnostic Test: Fibromyalgia study form, Diagnostic Test: Pulmonary function test, Diagnostic Test: Ultrasonographic Diaphragm Thickness MeasurementHealthy,volunteer men and women between the ages of 18-50 who applied to our clinic will be included in our study

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: It will consist of participants with fibromyalgia patients, according to the 2016 ACR (American College of Rheumatology) diagnostic criteria, who apply to the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences Gaziosmanpasa Training and Research Hospital within the study date ranges, meet the inclusion and exclusion criteria and voluntarily agree to participate in the research. Healthy individuals identical in age and gender will be included in the study as a control group. Demographic information (Fibromyalgia study form, consisting of clinical measurement, Fibromyalgia impact questionnaire (FIQ), Beck Anxiety Questionnaire and Beck Depression Questionnaire, Short-Form (SF)-36, ) of all individuals involved in the recruitment will be collected.

Key inclusion criteria (4 listed)

Patients diagnosed with fibromyalgia according to the 2016 ACR (American College of Rheumatology) diagnostic criteria without any comorbidities (such as liver, kidney failure, DM, rheumatic disease)
Patients who underwent Pulmonary Function Test (PFT)
Patients without pulmonary disease
18 -50 years old women and men

Key exclusion criteria (7 listed)

Congenital spinal, costal and diaphragmatic anomalies neuromuscular disease
Respiratory system diseases that affect lung functions
Patients who cannot cooperate with spirometry.
Having surgery to the chest wall or spine
Those with BMI > 25

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fibromyalgia study formFibromyalgia study form, consisting of clinical measurement, Fibromyalgia impact questionnaire (FIQ), Beck Anxiety Questionnaire and Beck Depression Questionnaire, Short-Form (SF)-36, who applied to the outpatient clinic with fibromyalgia will be filled in detail.	Diagnostic test	Control group, Patient group
Pulmonary function testAlso: Spirometry function testPulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders. The investigators will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.	Diagnostic test	Control group, Patient group
Ultrasonographic Diaphragm Thickness MeasurementDiaphragm thickness (millimeter-mm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (millimeter-mm), end-inspiratory (Total Lung Capacity) (millimeter-mm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken.	Diagnostic test	Control group, Patient group

Primary outcome

Fibromyalgia study form
Time frame: Within 1 month of applying to the outpatient clinic
Fibromyalgia study form, consisting of clinical measurement (2016 ACR (American College of Rheumatology) fibromyalgia diagnostic criteria, Fibromyalgia impact questionnaire (FIQ), Beck Anxiety Questionnaire and Beck Depression Questionnaire, Short-Form (SF)-36), who applied to the outpatient clinic with fibromyalgia will be filled in detail.
Pulmonary function test
Time frame: Within 1 month of applying to the outpatient clinic
The investigators will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.
Ultrasonographic Diaphragm Thickness Measurement
Time frame: Within 1 month of applying to the outpatient clinic
Diaphragm thickness (millimeter-mm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (millimeter-mm), end-inspiratory (Total Lung Capacity) (millimeter-mm) and thickening rate (%) (thickness TLC / thickness FRC) (percentage) will be evaluated three times and the arithmetic average of these three measurements will be taken.
Fibromyalgia diagnostic criteria
Time frame: Within 1 month of applying to the outpatient clinic
2016 revised American College of Rheumatology fibromyalgia diagnostic criteria; A patient satisfies the modified 2016 fibromyalgia criteria if the following three conditions are met: 1. Widespread pain index (WPI) ≥7 and symptom severity scale (SSS) score ≥5, or WPI of 4∼6 and SSS score ≥9. 2. Generalized pain, defined as pain in at least four of five regions, must be present. Jaw, chest, and abdominal pain are excluded from the generalized pain definition. 3. Symptoms have been generally present for at least 3 months. 4. A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses.
Fibromyalgia diagnostic criteria-Widespread pain index (WPI)
Time frame: Within 1 month of applying to the outpatient clinic
Ascertainment 1. WPI: note the number of areas in which the patient has had pain over the past week. In how many areas has the patient had pain? Score will be between 0 and 19 (Region 1) (Left upper region); jaw, left shoulder girdle, left upper arm, left lower arm, (Region 2) (Right upper region); jaw, right shoulder girdle, right upper arm, right lower arm, (Region 3) (Left lower region); hip (buttock, trochanter), left upper leg, left lower leg, (Region 4) (Right lower region); hip (buttock, trochanter), right upper leg, right lower leg and (Region 5) (Axial region); neck, upper back, lower back, chest, abdomen
Fibromyalgia diagnostic criteria-Symptom severity scale (SSS)
Time frame: Within 1 month of applying to the outpatient clinic
2. SSS score Fatigue Waking unrefreshed Cognitive symptoms For each of the three symptoms above, indicate the level of severity over the past week using the following scale: 0=no problem 1=slight or mild problems, generally mild or intermittent 2=moderate, considerable problems, often present and/or at a moderate level 3=severe: pervasive, continuous, life-disturbing problems The SSS score is the sum of the severity scores of the three symptoms (fatigue, waking unrefreshed, and cognitive symptoms) (0∼9), plus the sum (0∼3) of the number of the following symptoms the patient has been bothered by that occurred during the previous 6 months: 1.Headaches (0∼1) 2. Pain or cramps in lower abdomen (0∼1) 3. Depression (0∼1). The final symptom severity score is between 0 and 12 The fibromyalgia severity scale is the sum of the WPI and SSS

4 secondary outcomes

Fibromyalgia Impact Questionnaire
Time frame: Within 1 month of applying to the outpatient clinic
Beck Anxiety Inventory
Time frame: Within 1 month of applying to the outpatient clinic
Beck Depression Inventory
Time frame: Within 1 month of applying to the outpatient clinic
Short Form- 36 (SF-36)
Time frame: Within 1 month of applying to the outpatient clinic

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 28 Jan 2025.
Results publication: PubMed 20461783Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
Results publication: PubMed 34001303Sarzi-Puttini P, Giorgi V, Atzeni F, Gorla R, Kosek E, Choy EH, Bazzichi L, Hauser W, Ablin JN, Aloush V, Buskila D, Amital H, Da Silva JAP, Perrot S, Morlion B, Polati E, Schweiger V, Coaccioli S, Varrassi G, Di Franco M, Torta R, Oien Forseth KM, Mannerkorpi K, Salaffi F, Di Carlo M, Cassisi G, Batticciotto A. Fibromyalgia position paper. Clin Exp Rheumatol. 2021 May-Jun;39 Suppl 130(3):186-193. doi: 10.55563/clinexprheumatol/i19pig. Epub 2021 May 13.
Results publication: PubMed 34001307Alciati A, Nucera V, Masala IF, Giallanza M, La Corte L, Giorgi V, Sarzi-Puttini P, Atzeni F. One year in review 2021: fibromyalgia. Clin Exp Rheumatol. 2021 May-Jun;39 Suppl 130(3):3-12. doi: 10.55563/clinexprheumatol/gz4i3i. Epub 2021 May 13.
Results publication: PubMed 33857393Ortiz-Rubio A, Torres-Sanchez I, Cabrera-Martos I, Lopez-Lopez L, Rodriguez-Torres J, Granados-Santiago M, Valenza MC. Respiratory disturbances in fibromyalgia: A systematic review and meta-analysis of case control studies. Expert Rev Respir Med. 2021 Sep;15(9):1217-1227. doi: 10.1080/17476348.2021.1918547. Epub 2021 Apr 26.
Results publication: PubMed 35748715Tomas-Carus P, Biehl-Printes C, Del Pozo-Cruz J, Parraca JA, Folgado H, Perez-Sousa MA. Effects of respiratory muscle training on respiratory efficiency and health-related quality of life in sedentary women with fibromyalgia: a randomised controlled trial. Clin Exp Rheumatol. 2022 Jun;40(6):1119-1126. doi: 10.55563/clinexprheumatol/0v55nh. Epub 2022 Jun 22.
Results publication: PubMed 26357011Noda Y, Sekiguchi K, Kohara N, Kanda F, Toda T. Ultrasonographic diaphragm thickness correlates with compound muscle action potential amplitude and forced vital capacity. Muscle Nerve. 2016 Apr;53(4):522-7. doi: 10.1002/mus.24902. Epub 2015 Oct 10.
Individual participant dataSharing planned: No

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Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome

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.

Betul Ciftci, MD,Associate Professor principal investigator

Kirklareli University Faculty of Health Sciences

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 Anxiety, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).

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 4 inclusion and 7 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 28 Jan 2025. 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 Turkey (Türkiye). 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?

Fibromyalgia study form (time frame: Within 1 month of applying to the outpatient clinic). The study lists 6 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 NCT06396949, which also lists 6 linked publications.

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 28 Jan 2025.