Fatigue Levels in Fibromyalgia Syndrome

NCT ID: NCT04827550

Last Updated: 2022-07-13

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

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-09-01

Brief Summary

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Ninety (90) woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included. The Fibromyalgia Impact Questionnaire (FIQ) is used to assess the patient's functionality and determine the severity of the disease. The Fatigue Severity Scale (FSS) assessed the level and severity of fatigue. The short form of the International Physical Activity Questionnaire (IPAQ-SF) used to asess physical activity levels.The kinesiophobia level was assessed by using the Tampa Scale for Kinesiophobia.

Detailed Description

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Our study consists of 180 female participants aged between 18 and 65 years who applied to the physical therapy and rehabilitation outpatient clinic between April 2021 and August 2021. This case-control study was conducted according to the Declaration of Helsinki. Participants gave written voluntary consent and enrolled in this case-control study.

Ninety (90) woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included. Fibromyalgia Impact Questionnaire, Tampa Kinesiophobia Scale, Fatigue Severity Scale and The short form of İnternational Physical Activity Questionnaire (IPAQ-SF) were completed. All scales were filled in face to face for the participants. In addition, demographic data (age, gender, height, weight, marital status, education level) and duration of fibromyalgia diagnosis were recorded.

Exclusion criteria for both groups; The presence of health problems that affect the level of physical activity ( Cardiac or pulmonary insufficiency, limb amputation, recent surgery history) and cognitive impairment that prevents answer questions

Conditions

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Fatigue Fibromyalgia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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STUDY GROUP

diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria

STUDY

Intervention Type OTHER

Fibromyalgia Patient

CONTROL GROUP

90 healthy volunteers

STUDY

Intervention Type OTHER

Fibromyalgia Patient

Interventions

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STUDY

Fibromyalgia Patient

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ninety (90) woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria
* Ninety (90) healthy volunteers

Exclusion Criteria

* The presence of health problems that affect the level of physical activity ( Cardiac or pulmonary insufficiency, limb amputation, recent surgery history)
* Cognitive impairment that prevents answer questions
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yerkoy State Hospital

OTHER

Sponsor Role lead

Responsible Party

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Başak Çiğdem Karaçay

specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Basak CigdemKaracay, Spesialist

Role: PRINCIPAL_INVESTIGATOR

Yerkoy State Hospital

Locations

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Yerkoy State Hospital

Yerköy, Yozgat, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Gencay-Can A, Can SS. Validation of the Turkish version of the fatigue severity scale in patients with fibromyalgia. Rheumatol Int. 2012 Jan;32(1):27-31. doi: 10.1007/s00296-010-1558-3. Epub 2010 Jul 24.

Reference Type BACKGROUND
PMID: 20658235 (View on PubMed)

Bennett R. The Fibromyalgia Impact Questionnaire (FIQ): a review of its development, current version, operating characteristics and uses. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S154-62.

Reference Type BACKGROUND
PMID: 16273800 (View on PubMed)

Burwinkle T, Robinson JP, Turk DC. Fear of movement: factor structure of the tampa scale of kinesiophobia in patients with fibromyalgia syndrome. J Pain. 2005 Jun;6(6):384-91. doi: 10.1016/j.jpain.2005.01.355.

Reference Type BACKGROUND
PMID: 15943960 (View on PubMed)

Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.

Reference Type BACKGROUND
PMID: 2803071 (View on PubMed)

Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.

Reference Type BACKGROUND
PMID: 21058606 (View on PubMed)

Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.

Reference Type BACKGROUND
PMID: 22018588 (View on PubMed)

Other Identifiers

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2017-KAEK-189_2021.03.10_18

Identifier Type: -

Identifier Source: org_study_id

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