FibromyalgiaNCT03757702
Trunk Position Sense, Postural Stability and Spinal Posture in Fibromyalgia
An observational study of Fibromyalgia and Postural Lordosis, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate trunk position sense, postural stability and spine posture in fibromyalgia patients and healthy women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Postural Lordosis, Postural Kyphosis
- What is being tested?
- Evaluation
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2018to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy women and Fibromyalgia patient
Who may be able to join
- being women
- having FMS
- being volunteer
Who cannot join
- have neurologic, infectious, endocrine, and other severe psychological disorders
- malignancy,
- being pregnant
- any condition interfering with evaluation (advanced cardiac respiratory or orthopedic problems)
- spinal deformities such as scoliosis, spine surgery
- inflammatory rheumatic diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University
Ankara, 06010
About this study
Official title: Investigation of Trunk Position Sense, Postural Stability and Posture in Fibromyalgia Patients and Healthy Women
This study aims to investigate trunk position sense, postural stability and spine posture in fibromyalgia patients and healthy women.
- Conditions
- Fibromyalgia, Postural Lordosis, Postural Kyphosis, Proprioception, Postural Stability, Balance
- Being tested
- Evaluation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
Trunk position sense will be evaluated with a digital inclinometer. Trunk reposition test will be used in evaluation.The postural stability will be evaluated with a special balance device in eyes opened and closed position. Ellipse area (mm2) and perimeter (mm) parameters will be recorded.The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer.
| Study group | Role | What they receive |
|---|---|---|
| Fibromiyalgia group | women with FMS between 18-65 years of age and being volunteered. Receives: Other: Evaluation | |
| Healthy group | healthy women and being volunteereed Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Position Sense
Trunk position sense will be evaluated with a digital inclinometer.
Measured: 20 days
Secondary outcomes (2)
Postural Stability
The postural stability will be evaluated with a special balance device in eyes opened and closed position.
Measured: 20 days
Spinal Posture
.The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start10 Jul 2018
- Primary completion30 Nov 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Özge Çoban, Study chair, Research Assitant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757702
- Sponsor's protocol ID
- 43
- Status last verified
- Nov 2018
- First submitted
- 26 Nov 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Trunk Position Sense, Postural Stability and Posture in Fibromyalgia Patients and Healthy Women
- ClinicalTrials.gov ID
- NCT03757702
- Acronym / sponsor ID
- 43
- Conditions
- Fibromyalgia, Postural Lordosis, Postural Kyphosis, Proprioception, Postural Stability, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate trunk position sense, postural stability and spine posture in fibromyalgia patients and healthy women.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromiyalgia group | – | Other: Evaluationwomen with FMS between 18-65 years of age and being volunteered. |
| Healthy group | – | Other: Evaluationhealthy women and being volunteereed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy women and Fibromyalgia patient
Key inclusion criteria (3 listed)
- being women
- having FMS
- being volunteer
Key exclusion criteria (6 listed)
- have neurologic, infectious, endocrine, and other severe psychological disorders
- malignancy,
- being pregnant
- any condition interfering with evaluation (advanced cardiac respiratory or orthopedic problems)
- spinal deformities such as scoliosis, spine surgery
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 |
|---|---|---|
| EvaluationTrunk position sense will be evaluated with a digital inclinometer. Trunk reposition test will be used in evaluation.The postural stability will be evaluated with a special balance device in eyes opened and closed position. Ellipse area (mm2) and perimeter (mm) parameters will be recorded.The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer. | Other | Fibromiyalgia group, Healthy group |
Primary outcome
Joint Position Sense
Time frame: 20 days
Trunk position sense will be evaluated with a digital inclinometer.
2 secondary outcomes
Postural Stability
Time frame: 20 days
Spinal Posture
Time frame: 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Özge Çoban study chair
Research Assitant
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 Postural Lordosis, run by Ankara Yildirim Beyazıt University 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 3 inclusion and 6 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 23 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Joint Position Sense (time frame: 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2019; AzTrials last refreshed its copy on 30 Oct 2026.