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NCT03778801

Kinesiophobia in Patients With Fibromyalgia Syndrome and Chronic Neck Pain

Completed Results posted Last updated 31 January 2025
What this trial tests

trial testing kinesiophobia in Fibromyalgia in 90 participants. Completed in 7 December 2018.

Timeline
1 October 2018
Primary endpoint
3 December 2018
7 December 2018

Quick facts

Lead sponsorAksaray University Training and Research Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment90
Start date1 October 2018
Primary completion3 December 2018
Estimated completion7 December 2018
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Aksaray University Training and Research Hospital

Who can join

Adults 18 to 65, any sex, with Fibromyalgia or Neck Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Tampa Scale of Kinesiophobia Primary · 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.

GroupValue95% CI
Fibromyalgia Syndrome41.70± 6.30
Chronic Neck Pain38.33± 7.98
Healthy Controls30.83± 8.84
International Physical Activity Questionnaire Short Form Primary · 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 da

GroupValue95% CI
Fibromyalgia Syndrome21
Chronic Neck Pain14
Healthy Controls7
Fibromyalgia Syndrome7
Chronic Neck Pain11
Healthy Controls16
Fibromyalgia Syndrome2
Chronic Neck Pain5
Healthy Controls7
Beck Depression Inventory Primary · 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.

GroupValue95% CI
Fibromyalgia Syndrome18.37± 8.07
Chronic Neck Pain12.03± 7.09
Healthy Controls5.44± 5.68
Fibromyalgia Impact Questionnaire Primary · 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.

GroupValue95% CI
Fibromyalgia Syndrome49.79± 22.60
Chronic Neck Pain44.44± 15.71
Healthy Controls13.79± 10.17
Neck Pain Disability Index Primary · 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.

GroupValue95% CI
Chronic Neck Pain49.06± 21.65
Healthy Controls6.16± 10.21
Visual Analog Scale for the Evaluation of Pain Primary · 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.

GroupValue95% CI
Fibromyalgia Syndrome75.83± 27.26
Chronic Neck Pain50.33± 23.85
Healthy Controls0± 0
Visual Analog Scale for the Evaluation of Fatigue Primary · 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.

GroupValue95% CI
Fibromyalgia Syndrome74.66± 28.37
Chronic Neck Pain64.33± 24.59
Healthy Controls41.66± 23.05

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of kinesiophobia

Trials testing the same drug.

Other recruiting trials for Fibromyalgia

Currently open trials in the same condition.

Other Aksaray University Training and Research Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03778801.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing