The Relationship Between Diaphragm Muscle Thickness and Fibromyalgia

NCT ID: NCT06396949

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-15

Study Completion Date

2024-05-30

Brief Summary

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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.

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.

Detailed Description

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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

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Fibromyalgia Anxiety Depression Diaphragm Issues

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Fibromyalgia study form

Intervention Type DIAGNOSTIC_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 test

Intervention Type DIAGNOSTIC_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 Measurement

Intervention Type DIAGNOSTIC_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.

Control group

Healthy,volunteer men and women between the ages of 18-50 who applied to our clinic will be included in our study

Fibromyalgia study form

Intervention Type DIAGNOSTIC_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 test

Intervention Type DIAGNOSTIC_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 Measurement

Intervention Type DIAGNOSTIC_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.

Interventions

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Fibromyalgia study form

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.

Intervention Type DIAGNOSTIC_TEST

Pulmonary 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.

Intervention Type DIAGNOSTIC_TEST

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) will be evaluated three times and the arithmetic average of these three measurements will be taken.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Spirometry function test

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Betul Ciftci, MD,Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Kirklareli University Faculty of Health Sciences

Locations

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Deniz Oke

Istanbul, Gaziosmanpasa, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 20461783 (View on PubMed)

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.

Reference Type RESULT
PMID: 34001303 (View on PubMed)

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.

Reference Type RESULT
PMID: 34001307 (View on PubMed)

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.

Reference Type RESULT
PMID: 33857393 (View on PubMed)

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.

Reference Type RESULT
PMID: 35748715 (View on PubMed)

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.

Reference Type RESULT
PMID: 26357011 (View on PubMed)

Other Identifiers

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97

Identifier Type: -

Identifier Source: org_study_id

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