Kinesiophobia in Patients With Fibromyalgia Syndrome and Chronic Neck Pain

Healthy Clinical Trial

Official title:

Evaluation of Kinesiophobia and Physical Activity Levels in Patients With Fibromyalgia Syndrome and Chronic Neck Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778801
• Other study ID #: 2018/155
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: December 7, 2018

Study information

• Verified date: December 2018
• Source: Aksaray University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Kinesiophobia which is described as fear of movement reduces physical activity levels and increases the risk of chronic pain. We consider that kinesiophobia levels were higher in patients with fibromyalgia syndrome and chronic neck pain so that physical activity levels were lower in this patients groups. Because there are not enough studies, we aimed to evaluate kinesiophobia and physical activity levels in this patients.

Description:

Objective: To evaluate pain, kinesiophobia, physical activity, depression, disease severity, and fatigue in patients with fibromyalgia syndrome or chronic neck pain and healthy controls.

Design: Cross-sectional study. Setting: Tertiary Health Care Center, Aksaray, Turkey Participants: 30 patients with fibromyalgia syndrome (Group 1), 30 patients with chronic neck pain (Group 2), and 30 healthy individuals (Group 3) were included.

Main Outcome Measures: Outcome measures were Visual Analogue Scale (VAS)-pain and fatigue, Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), International Physical Activity Questionnaire (IPAQ) Short Form, Fibromyalgia Impact Questionnaire (FIQ), Neck Pain Disability Index (NPDI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 7, 2018
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

disease duration more than three years for patient groups no pain and additional disease for healthy controls

Exclusion Criteria:

malignancy systemic infectious and rheumatic diseases history of operation having received physical therapy or intra-articular or intra-ligamentary injection within the last three months previous diagnosis of a psychological or cognitive disorder history of pregnancy

Related Conditions & MeSH terms

• Fibromyalgia
• Healthy
• Myofascial Pain Syndromes
• Neck Pain

Intervention

Diagnostic Test:
• fibromyalgia syndrome and chronic neck pain
We assessed pain intensity, kinesiophobia, fatigue, depression, physical activity level and disability in patients with fibromyalgia syndrome and chronic neck pain, and healthy individuals in this cross-sectional study.

Locations

Country	Name	City	State
Turkey	Aksaray University Training and Research Hospital	Aksaray

Sponsors (1)

Lead Sponsor	Collaborator
Aksaray University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tampa Scale of Kinesiophobia	Based on a four-point Likert type, this scale contains 17 items that evaluate fear and anxiety related to physical activity. A total score of greater than 37 is accepted as statistically significant and interpreted as a high level of kinesiophobia. minimal and maximal scores could be between 17-68 points. higher scores indicate higher levels of kinesiophobia.	4-8 minutes
Primary	International Physical Activity Questionnaire Short Form	It consists of seven items that measure the duration of the participants' physical activity, walking and sitting within the last seven days in the metabolic equivalent (MET)-min/week unit. 3 or more days of vigorous activity of at least 20 minutes per day or 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day or 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 metabolic equivalent (MET)-minutes/week are proposed to be moderate level. Vigorous-intensity activity on at least 3 days and accumulating at least 1500 metabolic equivalent (MET)-minutes/week or 7 or more days of any combination of walking, moderate- or vigorous-intensity activities accumulating at least 3000 metabolic equivalent (MET)-minutes/week are proposed to be high level. Some activity is reported but not enough to meet categories of moderate or high levels.	5-10 minutes
Primary	Beck Depression Inventory	This is a 21-item questionnaire that investigates the characteristic attitudes and symptoms of depression. A score of 10 or higher indicates depression. Minimal and maximal scores can be 0-63 points. Higher scores indicate higher levels of depression.	10 minutes
Primary	Fibromyalgia Impact Questionnaire	It aims to evaluate the arthritis symptoms and functional status of patients with fibromyalgia syndrome through 21 questions that inquire about physical functions, work-related situations, depression, anxiety, waking up tired, pain, stiffness, and fatigue. Higher scores indicate greater impact of fibromyalgia on functioning. Final score should range from 0 to 80.	5 minutes
Primary	Neck Pain Disability Index	This index consists of 20 questions that assess severity of neck pain and the extent to which the pain affects the social, professional and daily activities of patients.Final score should range from 0 to 100. Higher scores indicate greater levels of disability.	5-8 minutes
Primary	Visual Analog Scale for the Evaluation of Pain and Fatigue	For this evaluation, the patient is asked to mark his/her severity of pain and fatigue on a horizontal 10-cm line with number 0 on one end representing "no pain or no fatigue" and number 10 on the other end indicating "very severe pain or very severe fatigue". Higher scores indicate higher levels of pain intensity or fatigue.	0.5 minutes