Fatigue Levels in Fibromyalgia Syndrome

NCT04827550 | Completed

• 1 other identifier: 2017-KAEK-189_2021.03.10_18
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue; Fibromyalgia

Keywords

Fibromyalgia Syndrome; Physical Activity; kinesiophobia

Outcome Measures

Primary Outcomes (1)

• fatigue

  The Fibromyalgia Impact Questionnaire (FIQ) is used to assess the patient's functionality and determine the severity of the disease. The scale consists of 10 items and each item is 10 points. Therefore, the total maximum score is 100 points. Increasing scores indicate higher disease activity and lower functional status

  Baseline (0 day)

Secondary Outcomes (1)

• Kinesiophobia

  Baseline (0 day)

Other Outcomes (2)

• Physical Activity Levels

  Baseline (0 day)

• functionality

  Baseline (0 day)

Study Arms (2)

STUDY GROUP

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

Other: STUDY

CONTROL GROUP

90 healthy volunteers

Other: STUDY

Interventions

STUDY OTHER

Fibromyalgia Patient

CONTROL GROUP; STUDY GROUP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Our study consists of 180 female participants aged between 18 and 65 years who applied to the physical therapy and rehabilitation outpatient clinic.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yerkoy State Hospital: lead

Study Sites (1)

Yerkoy State Hospital

Yerköy, Yozgat, 66900, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 20658235 BACKGROUND

• 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.

  PMID: 16273800 BACKGROUND

• 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.

  PMID: 15943960 BACKGROUND

• 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.

  PMID: 2803071 BACKGROUND

• 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.

  PMID: 21058606 BACKGROUND

• 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.

  PMID: 22018588 BACKGROUND

MeSH Terms

Conditions

Fatigue; Fibromyalgia; Motor Activity; Kinesiophobia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Basak CigdemKaracay, Spesialist

  Yerkoy State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 1, 2021
• Study Start: February 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

TU (1)