Clinical trial NCT06396949: The Relationship Between Diaphragm Muscle Thickness and Fibromyalgia
Official title: The Relationship Between Diaphragm Muscle Thickness and Anxiety, Depression and Activities of Daily Living in Fibromyalgia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Anxiety
Depression
Diaphragm Issues
Keywords: Diaphragm thickness
Activities of daily living
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fibromyalgia study form
timeFrame: Within 1 month of applying to the outpatient clinic
measure: Pulmonary function test
timeFrame: Within 1 month of applying to the outpatient clinic
measure: Ultrasonographic Diaphragm Thickness Measurement
timeFrame: Within 1 month of applying to the outpatient clinic
measure: Fibromyalgia diagnostic criteria
timeFrame: Within 1 month of applying to the outpatient clinic
measure: Fibromyalgia diagnostic criteria-Widespread pain index (WPI)
timeFrame: Within 1 month of applying to the outpatient clinic
measure: Fibromyalgia diagnostic criteria-Symptom severity scale (SSS)
timeFrame: Within 1 month of applying to the outpatient clinic
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire
timeFrame: Within 1 month of applying to the outpatient clinic
measure: Beck Anxiety Inventory
timeFrame: Within 1 month of applying to the outpatient clinic
measure: Beck Depression Inventory
timeFrame: Within 1 month of applying to the outpatient clinic
measure: Short Form- 36 (SF-36)
timeFrame: Within 1 month of applying to the outpatient clinic
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Deniz Oke
state: Gaziosmanpasa
Study officials:
affiliation: Kirklareli University Faculty of Health Sciences
name: Betul Ciftci, MD,Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.