Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 967 for:    fibromyalgia

Kinesiophobia in Patients With Fibromyalgia Syndrome and Chronic Neck Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03778801
Recruitment Status : Completed
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Melek Aykut Selçuk, Aksaray University Training and Research Hospital

Brief 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.

Condition or disease Intervention/treatment
Fibromyalgia Neck Pain Healthy Diagnostic Test: fibromyalgia syndrome and chronic neck pain

Detailed 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).


Layout table for study information
Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of Kinesiophobia and Physical Activity Levels in Patients With Fibromyalgia Syndrome and Chronic Neck Pain
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : December 3, 2018
Actual Study Completion Date : December 7, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
fibromyalgia syndrome
Thirty patients with a diagnosis of fibromyalgia syndrome according to the 2016 revised American College of Rheumatology Fibromyalgia Syndrome diagnostic criteria and a disease duration of longer than three months
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.
Other Names:
  • physical activity level
  • pain intensity
  • disability
  • fatigue
  • depression

chronic neck pain
30 patients with chronic neck pain lasting for more than three months and didn't meet 2016 revised American College of Rheumatology Fibromyalgia Syndrome diagnostic criteria.
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.
Other Names:
  • physical activity level
  • pain intensity
  • disability
  • fatigue
  • depression

healthy controls
30 healthy controls without pain or additional disease
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.
Other Names:
  • physical activity level
  • pain intensity
  • disability
  • fatigue
  • depression




Primary Outcome Measures :
  1. Tampa Scale of Kinesiophobia [ Time Frame: 4-8 minutes ]
    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.

  2. International Physical Activity Questionnaire Short Form [ Time Frame: 5-10 minutes ]
    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.

  3. Beck Depression Inventory [ Time Frame: 10 minutes ]
    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.

  4. Fibromyalgia Impact Questionnaire [ Time Frame: 5 minutes ]
    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. Neck Pain Disability Index [ Time Frame: 5-8 minutes ]
    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.

  6. Visual Analog Scale for the Evaluation of Pain and Fatigue [ Time Frame: 0.5 minutes ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The patients were recruited from a physical medicine and rehabilitation outpatients clinic of Aksaray University Training and Research Hospital, Aksaray, Turkey. The healthy control group was consisting of doctors, nurses, medical secretaries who work in Aksaray University Training and Research Hospital, and patient care providers that have no pain and additional diseases
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778801


Locations
Layout table for location information
Turkey
Aksaray University Training and Research Hospital
Aksaray, Turkey
Sponsors and Collaborators
Aksaray University Training and Research Hospital
Investigators
Layout table for investigator information
Principal Investigator: Melek A Selçuk Aksaray University Training and Research Hospital
  Study Documents (Full-Text)

Documents provided by Dr. Melek Aykut Selçuk, Aksaray University Training and Research Hospital:
Study Protocol  [PDF] November 16, 2018


Layout table for additonal information
Responsible Party: Dr. Melek Aykut Selçuk, Principal Investigator, Aksaray University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03778801     History of Changes
Other Study ID Numbers: 2018/155
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Melek Aykut Selçuk, Aksaray University Training and Research Hospital:
kinesiophobia
physical activity
disability

Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Neck Pain
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms