Trial Outcomes & Findings for Kinesiophobia in Patients With Fibromyalgia Syndrome and Chronic Neck Pain (NCT NCT03778801)

NCT ID: NCT03778801

Last Updated: 2025-01-31

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

90 participants

Primary outcome timeframe

4-8 minutes

Results posted on

2025-01-31

Participant Flow

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

Participant milestones

Participant milestones
Measure
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 kinesiophobia: 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.
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. kinesiophobia: 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.
Healthy Controls
30 healthy controls without pain or additional disease kinesiophobia: 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.
Overall Study
STARTED
30
30
30
Overall Study
COMPLETED
30
30
30
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Fibromyalgia Syndrome
n=30 Participants
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 kinesiophobia: 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.
Chronic Neck Pain
n=30 Participants
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. kinesiophobia: 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.
Healthy Controls
n=30 Participants
30 healthy controls without pain or additional disease kinesiophobia: 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.
Total
n=90 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=90 Participants
Age, Categorical
Between 18 and 65 years
30 Participants
n=30 Participants
30 Participants
n=30 Participants
30 Participants
n=30 Participants
90 Participants
n=90 Participants
Age, Categorical
>=65 years
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=90 Participants
Age, Continuous
42.96 years
STANDARD_DEVIATION 10.88 • n=30 Participants
38.50 years
STANDARD_DEVIATION 11.65 • n=30 Participants
35.40 years
STANDARD_DEVIATION 9.95 • n=30 Participants
38.91 years
STANDARD_DEVIATION 11.15 • n=90 Participants
Sex: Female, Male
Female
28 Participants
n=30 Participants
27 Participants
n=30 Participants
22 Participants
n=30 Participants
77 Participants
n=90 Participants
Sex: Female, Male
Male
2 Participants
n=30 Participants
3 Participants
n=30 Participants
8 Participants
n=30 Participants
13 Participants
n=90 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Turkey
30 Participants
n=30 Participants
30 Participants
n=30 Participants
30 Participants
n=30 Participants
90 Participants
n=90 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Fibromyalgia Syndrome
n=30 Participants
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 kinesiophobia: 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.
Chronic Neck Pain
n=30 Participants
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. kinesiophobia: 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.
Healthy Controls
n=30 Participants
30 healthy controls without pain or additional disease kinesiophobia: 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.
Tampa Scale of Kinesiophobia
41.70 score on a scale
Standard Deviation 6.30
38.33 score on a scale
Standard Deviation 7.98
30.83 score on a scale
Standard Deviation 8.84

PRIMARY outcome

Timeframe: 5-10 minutes

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.

Outcome measures

Outcome measures
Measure
Fibromyalgia Syndrome
n=30 Participants
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 kinesiophobia: 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.
Chronic Neck Pain
n=30 Participants
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. kinesiophobia: 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.
Healthy Controls
n=30 Participants
30 healthy controls without pain or additional disease kinesiophobia: 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.
International Physical Activity Questionnaire Short Form
low
21 Participants
14 Participants
7 Participants
International Physical Activity Questionnaire Short Form
moderate
7 Participants
11 Participants
16 Participants
International Physical Activity Questionnaire Short Form
high
2 Participants
5 Participants
7 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Fibromyalgia Syndrome
n=30 Participants
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 kinesiophobia: 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.
Chronic Neck Pain
n=30 Participants
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. kinesiophobia: 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.
Healthy Controls
n=30 Participants
30 healthy controls without pain or additional disease kinesiophobia: 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.
Beck Depression Inventory
18.37 score on a scale
Standard Deviation 8.07
12.03 score on a scale
Standard Deviation 7.09
5.44 score on a scale
Standard Deviation 5.68

PRIMARY outcome

Timeframe: 5 minutes

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.

Outcome measures

Outcome measures
Measure
Fibromyalgia Syndrome
n=30 Participants
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 kinesiophobia: 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.
Chronic Neck Pain
n=30 Participants
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. kinesiophobia: 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.
Healthy Controls
n=30 Participants
30 healthy controls without pain or additional disease kinesiophobia: 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.
Fibromyalgia Impact Questionnaire
49.79 score on a scale
Standard Deviation 22.60
44.44 score on a scale
Standard Deviation 15.71
13.79 score on a scale
Standard Deviation 10.17

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Fibromyalgia Syndrome
n=30 Participants
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 kinesiophobia: 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.
Chronic Neck Pain
n=30 Participants
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. kinesiophobia: 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.
Healthy Controls
30 healthy controls without pain or additional disease kinesiophobia: 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.
Neck Pain Disability Index
49.06 score on a scale
Standard Deviation 21.65
6.16 score on a scale
Standard Deviation 10.21

PRIMARY outcome

Timeframe: 0.5 minutes

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.

Outcome measures

Outcome measures
Measure
Fibromyalgia Syndrome
n=30 Participants
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 kinesiophobia: 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.
Chronic Neck Pain
n=30 Participants
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. kinesiophobia: 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.
Healthy Controls
n=30 Participants
30 healthy controls without pain or additional disease kinesiophobia: 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.
Visual Analog Scale for the Evaluation of Pain
75.83 score on a scale
Standard Deviation 27.26
50.33 score on a scale
Standard Deviation 23.85
0 score on a scale
Standard Deviation 0

PRIMARY outcome

Timeframe: 0.5 minutes

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.

Outcome measures

Outcome measures
Measure
Fibromyalgia Syndrome
n=30 Participants
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 kinesiophobia: 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.
Chronic Neck Pain
n=30 Participants
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. kinesiophobia: 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.
Healthy Controls
n=30 Participants
30 healthy controls without pain or additional disease kinesiophobia: 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.
Visual Analog Scale for the Evaluation of Fatigue
74.66 score on a scale
Standard Deviation 28.37
64.33 score on a scale
Standard Deviation 24.59
41.66 score on a scale
Standard Deviation 23.05

Adverse Events

Fibromyalgia Syndrome

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Chronic Neck Pain

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

Aksaray University training and Research Hospital

Phone: 905555289493

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place