Clinical trial NCT05323838: Influence of Co-diagnosis of Chronic Fatigue Syndrome in Patients With Fibromyalgia.
Official title: Influence of Co-diagnosis of Chronic Fatigue Syndrome in Patients With Fibromyalgia on Physical Activity, Quality of Life and Immunoneuroendocrine Response.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibromyalgia
Chronic Fatigue Syndrome
Comorbidities and Coexisting Conditions
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 140
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present investigation is carried out in two experimental groups: patients diagnosed with Fibromyalgia and patients diagnosed with Fibromyalgia and a co-diagnosis of Chronic Fatigue Syndrome, all of them volunteers facilitated through the Fibromyalgia Associations of Badajoz and Cáceres, Extremadura, Spain.

Brief summary: The purpose of this study is to evaluate differences in neuroimmunoendocrine response and quality of live in patients diagnosed with Fibromyalgia, with or without a co-diagnosis of Chronic Fatigue Syndrome.

Detailed description: The limited literature published in concordant relation affects the chronic fatigue syndrome comorbidity in the daily life of fibromyalgia patients leads us to design this study with the main objective of evaluating differences in the quality of life associated with pain and stress, mainly in relation to levels of physical activity, sedentary lifestyle and sleep in patients diagnosed with fibromyalgia, with or without a parallel co-diagnosis of chronic fatigue syndrome.

Eligibility criteria: Inclusion Criteria:

* Fibromyalgia and/or Chronic Fatigue Syndrome diagnosis by rheumatologists or internal medicine professionals.
* Age not less than 40 years old and not more than 65 years old.

Exclusion Criteria:

* Suffering from diagnosed "major depression".
* Suffer diagnosed multiple chemical sensitivity.
* Corticosteroid treatment or anti-cytokine therapies.
* Periodically carry out programmed therapeutic physical activity in the two months prior to the accelerometry tests.

Primary outcomes:
measure: Differences in perceived anxiety using the State-Trait Anxiety Inventory (STAI)
timeFrame: During the intervention, at day 1.
measure: Differences in perceived stress using The Perceived Stress Scale (PSS)
timeFrame: During the intervention, at day 1.
measure: Differences in perceived depression using the Beck's Depression Inventory (BDI)
timeFrame: During the intervention, at day 1.
measure: Differences in perceived pain using the Brief Pain Inventory (BPI)
timeFrame: During the intervention, at day 1.
measure: Differences in perceived pain using the Brief Fatigue Inventory (BFI)
timeFrame: During the intervention, at day 1.
measure: Differences in subjective quality of sleep using The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: During the intervention, at day 1.
measure: Differences in subjective quality of life using The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ)
timeFrame: During the intervention, at day 1.
measure: Differences in perceived anxiety related to Coronavirus Disease (COVID-19) using the Coronavirus Anxiety Scale (CAS)
timeFrame: During the intervention, at day 1.
measure: Differences in fear of Coronavirus Disease (COVID-19) using the Fear COVID-19 Scale (FCV-19S)
timeFrame: During the intervention, at day 1.
measure: Objective differences in physical activity, sedentary lifestyle and sleep using the accelerometer technique (ActiGraph)
timeFrame: Up to 1 week
measure: Determination of immuno-neuroendocrine parameters (cytokines, catecholamines, and stress hormones)
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: University of Extremadura
Study officials:
References:
citation: Adler GK, Geenen R. Hypothalamic-pituitary-adrenal and autonomic nervous system functioning in fibromyalgia. Rheum Dis Clin North Am. 2005 Feb;31(1):187-202, xi. doi: 10.1016/j.rdc.2004.10.002.
citation: Guillen-Riquelme A, Buela-Casal G. [Meta-analysis of group comparison and meta-analysis of reliability generalization of the State-Trait Anxiety Inventory Questionnaire (STAI)]. Rev Esp Salud Publica. 2014 Jan-Feb;88(1):101-12. doi: 10.4321/S1135-57272014000100007. Spanish.
citation: Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.
citation: BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
citation: Poquet N, Lin C. The Brief Pain Inventory (BPI). J Physiother. 2016 Jan;62(1):52. doi: 10.1016/j.jphys.2015.07.001. Epub 2015 Aug 21. No abstract available.
citation: Mendoza TR, Wang XS, Cleeland CS, Morrissey M, Johnson BA, Wendt JK, Huber SL. The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer. 1999 Mar 1;85(5):1186-96. doi: 10.1002/(sici)1097-0142(19990301)85:53.0.co;2-n.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
citation: Darviri C, Alexopoulos EC, Artemiadis AK, Tigani X, Kraniotou C, Darvyri P, Chrousos GP. The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ): a novel tool for assessing self-empowerment through a constellation of daily activities. BMC Public Health. 2014 Sep 24;14:995. doi: 10.1186/1471-2458-14-995.
citation: Freedson P, Bowles HR, Troiano R, Haskell W. Assessment of physical activity using wearable monitors: recommendations for monitor calibration and use in the field. Med Sci Sports Exerc. 2012 Jan;44(1 Suppl 1):S1-4. doi: 10.1249/MSS.0b013e3182399b7e.
citation: Lee SA. Coronavirus Anxiety Scale: A brief mental health screener for COVID-19 related anxiety. Death Stud. 2020;44(7):393-401. doi: 10.1080/07481187.2020.1748481. Epub 2020 Apr 16.
citation: Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.