FibromyalgiaNCT03778801

Kinesiophobia in Patients With Fibromyalgia Syndrome and Chronic Neck Pain

An observational study of Fibromyalgia and Neck Pain, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Fibromyalgia, Neck Pain, Healthy
What is being tested?: kinesiophobia
How many people: 90 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Oct 2018to 7 Dec 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Aksaray University Training and Research Hospital
Aksaray

Other trials in Turkey (Türkiye)

About this study

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

Read the 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).

Conditions: Fibromyalgia, Neck Pain, Healthy
Being tested: kinesiophobia
Keywords: kinesiophobia, physical activity, disability
Medical subject headings: Fibromyalgia, Neck Pain, Kinesiophobia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

kinesiophobiaDiagnostic test
Also called physical activity level, pain intensity, disability, fatigue
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.

Study groups in NCT03778801
Study group	Role	What they receive
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 Receives: 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. Receives: Diagnostic Test: kinesiophobia
healthy controls		30 healthy controls without pain or additional disease Receives: Diagnostic Test: kinesiophobia

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0.5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20187 Dec 2018

First posted19 Dec 2018
Study start1 Oct 2018
Primary completion3 Dec 2018
Study completion7 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03778801
Sponsor's protocol ID: 2018/155
Status last verified: Jan 2025
First submitted: 16 Dec 2018
Last updated: 31 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Recruiting
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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Kinesiophobia and Physical Activity Levels in Patients With Fibromyalgia Syndrome and Chronic Neck Pain
ClinicalTrials.gov ID: NCT03778801
Acronym / sponsor ID: 2018/155
Conditions: Fibromyalgia, Neck Pain, Healthy
Keywords: kinesiophobia, physical activity, disability
Study type: Observational
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Aksaray University Training and Research HospitalUniversity, hospital or other
Study start: 1 Oct 2018 (actual)
Primary completion: 3 Dec 2018 (actual)
Study completion: 7 Dec 2018 (actual)
First posted: 19 Dec 2018 (actual)
Results: Posted 31 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 3

Arm	Type	Receives
fibromyalgia syndrome	–	Diagnostic Test: kinesiophobiaThirty 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
chronic neck pain	–	Diagnostic Test: kinesiophobia30 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.
healthy controls	–	Diagnostic Test: kinesiophobia30 healthy controls without pain or additional disease

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
kinesiophobiaAlso: physical activity level, pain intensity, disability, fatigueThe 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.	Diagnostic test	chronic neck pain, fibromyalgia syndrome, healthy controls

Primary outcome

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.
International Physical Activity Questionnaire Short Form
Time frame: 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.
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.
Fibromyalgia Impact Questionnaire
Time frame: 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.
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.
Visual Analog Scale for the Evaluation of Pain
Time frame: 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.
Visual Analog Scale for the Evaluation of Fatigue
Time frame: 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.

Results and safety

Results posted to the registry on 31 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fibromyalgia Syndrome	30	30
Chronic Neck Pain	30	30
Healthy Controls	30	30

Primary outcome: Tampa Scale of Kinesiophobia

Time frame: 4-8 minutes. Mean (Standard Deviation). Unit: score on a scale

Measure	Fibromyalgia Syndrome n = 30	Chronic Neck Pain n = 30	Healthy Controls n = 30
Value	41.70 (6.30)	38.33 (7.98)	30.83 (8.84)

Primary outcome: International Physical Activity Questionnaire Short Form

Time frame: 5-10 minutes. Count of participants. Unit: Participants

Measure	Fibromyalgia Syndrome n = 30	Chronic Neck Pain n = 30	Healthy Controls n = 30
low	21	14	7
moderate	7	11	16
high	2	5	7

Primary outcome: Beck Depression Inventory

Time frame: 10 minutes. Mean (Standard Deviation). Unit: score on a scale

Measure	Fibromyalgia Syndrome n = 30	Chronic Neck Pain n = 30	Healthy Controls n = 30
Value	18.37 (8.07)	12.03 (7.09)	5.44 (5.68)

Primary outcome: Fibromyalgia Impact Questionnaire

Time frame: 5 minutes. Mean (Standard Deviation). Unit: score on a scale

Measure	Fibromyalgia Syndrome n = 30	Chronic Neck Pain n = 30	Healthy Controls n = 30
Value	49.79 (22.60)	44.44 (15.71)	13.79 (10.17)

Adverse events

Time frame: Adverse Events were not monitored/assessed. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Fibromyalgia Syndrome	0 of 0	0 of 0
Chronic Neck Pain	0 of 0	0 of 0
Healthy Controls	0 of 0	0 of 0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melek A Selçuk principal investigator

Aksaray University Training and Research Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia and Neck Pain, run by Aksaray University Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tampa Scale of Kinesiophobia (time frame: 4-8 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03778801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.