Kinesiophobia in Patients With Fibromyalgia Syndrome and Chronic Neck Pain

NCT03778801 | Completed Results

• 1 other identifier: 2018/155
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia; Neck Pain; Healthy

Keywords

kinesiophobia; physical activity; disability

Outcome Measures

Primary Outcomes (7)

• 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

• International Physical Activity Questionnaire Short Form

  This questionnaire 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 MET-minutes/week are proposed to be moderate level. Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week or 7 or more days of any combination of walking, moderate- or vigorous-intensity activities accumulating at least 3000 MET-minutes/week are proposed to be high level. Some activity is reported but not enough to meet categories of moderate or high levels, it is proposed to be low level.

  5-10 minutes

• 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

• Fibromyalgia Impact Questionnaire

  Fibromyalgia Impact Questionnaire 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

• 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

• Visual Analog Scale for the Evaluation of Pain

  For this evaluation, the patient is asked to mark his/her severity of pain on a horizontal 100-mm line with 0 on one end representing no pain and 100 on the other end represent very severe pain. Higher scores indicate higher levels of pain intensity.

  0.5 minutes

• Visual Analog Scale for the Evaluation of Fatigue

  For this evaluation, the patient is asked to mark his/her severity of fatigue on a horizontal 100-mm line with 0 on one end representing no fatigue and 100 on the other end represent very severe fatigue.

  0.5 minutes

Study Arms (3)

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: kinesiophobia

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: kinesiophobia

healthy controls

30 healthy controls without pain or additional disease

Diagnostic Test: kinesiophobia

Interventions

kinesiophobia DIAGNOSTIC_TEST

The investigators 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.

Also known as: physical activity level, pain intensity, disability, fatigue, depression

chronic neck pain; fibromyalgia syndrome; healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients were recruited from a physical medicine and rehabilitation outpatient 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

You may qualify if:

• Participants with a clinical diagnosis of fibromyalgia syndrome Participants with a clinical diagnosis of chronic neck pain Healthy participants Participants with fibromyalgia syndrome and chronic neck pain has had a disease duration more than three months

You may not qualify if:

• Malignant disease Systemic infectious disease Rheumatic disease Operation Pregnancy Psychological or cognitive disorder History of physical therapy within the last three months History of intra-articular or intra-ligamentary injection within the last three months

Sponsors & Collaborators

• Aksaray University Training and Research Hospital: lead

Study Sites (1)

Aksaray University Training and Research Hospital

Aksaray, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Neck Pain; Kinesiophobia; Motor Activity

Interventions

Pain Measurement; Disability Evaluation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

Small sample size, presence of a difference between the fibromyalgia syndrome and control groups in terms of age and gender, and lack of Neck Pain Disability Index evaluation in the fibromyalgia syndrome group.

Results Point of Contact

• Title: Principal Investigator
• Organization: Aksaray University training and Research Hospital

mlk.aykut@gmail.com

905555289493

Study Officials

• Melek A Selçuk

  Aksaray University Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 19, 2018
• Study Start: October 1, 2018
• Primary Completion: December 3, 2018
• Study Completion: December 7, 2018
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2025-01

Locations

TU (1)