Fibromyalgia, Cervical LordosisNCT06408675
Loss of Cervical Lordosis in Fibromyalgia Syndrome
An observational study of Fibromyalgia, Cervical Lordosis, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).
Trial summary
Purpose: The causes of chronic and widespread pain in fibromyalgia (FMS) have not been eluciated yet. Previous reports determined that posture control changed, muscle strength decreased, body posture misaligned (maladaptive posture), and functional capacity decreased in FMS patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia, Cervical Lordosis
- What is being tested?
- Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.
- How many people
- 107 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 30 Nov 2018
- How long will I take part?
- 3 Months
- 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
- All sexes
- Adult, Older adult
Study population: A total of 107 patients who applied to the physical therapy and rehabilitation outpatient clinic; . Age range between 18-65 , male-female, Patients diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria
Who may be able to join
- Age range between 18 and 65
- -Patients diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria
Who cannot join
- Patients diagnosed with known systemic (e.g., inflammatory rheumatic diseases, diabetes mellitus and systemic arterial hypertension), metabolic or endocrine diseasesas well as tumoral, neurologic or infectious diseases,
- Patients with a history of trauma and surgery affecting the neck area,
- Patients who received trigger point injection therapy for neck pain within the last 6 months,
- Patients with cervical disc herniation or myelopathy, spondylolisthesis, spondylolysis, cervicothoracic kyphoscoliosis,
- Patients who had been receiving therapy for any psychiatric diagnosis for the last 3 months and antidepressant drug use,
- Patients with history of neuropathic diseases,
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- Patients with a condition affecting neck muscles, such as dystonia,
- Inflammatory muscle disease and myopathy
- Pregnant patients were not included to the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara City Hospital
Ankara, Çankaya, 06800
Emine Esra Bilir
Ankara, Çankaya, 06800
About this study
Official title: Loss of Cervical Lordosis an Association of Fibromyalgia Syndrome
Purpose: The causes of chronic and widespread pain in fibromyalgia (FMS) have not been eluciated yet. Previous reports determined that posture control changed, muscle strength decreased, body posture misaligned (maladaptive posture), and functional capacity decreased in FMS patients. The aim of this study was to investigate the relationship between loss of cervical lordosis, pain, quality of life (QOL) and neck disability in patients with FMS.
Methods: A total of 107 FMS (88 females and 20 males; range of age:18-65) were included to the study. Patients were divided into two groups according to the angle of cervical lordosis measured by the Cobb method, group 1 with a Cobb angle of ≤10°, and group 2 with an angle greater than >10°. Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.
- Conditions
- Fibromyalgia, Cervical Lordosis
- Being tested
- Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.
- Keywords
- Fibromyalgia, cervical lordosis
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.Other
Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.
| Study group | Role | What they receive |
|---|---|---|
| group 1 with a Cobb angle of ≤10° | cervical lordosis cobb angele ≤10° Receives: Other: Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively. | |
| group 2 with an angle greater than >10° | cervical lordosis cobb angele >10° Receives: Other: Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
VAS scale used to measure the severity of pain (0-10 cm). According to this scale, the value 0 means no pain and the value 10 means very severe pain
Measured: day 1,
Secondary outcomes (2)
Quality of Life Scale-Short Form (SF-36)
This scale assesses many aspects of health and consists of 36 questions with 8 subtitles. The assessment is performed considering the last 4 weeks of the patient and the scale is assessed between 0 point and 100 points in which score 100 shows good health state, the score 0 shows poor health state
Measured: day 1.
Neck disability index (NDI)
This form has a total of 10 items, which includes pain severity, personal care, lifting, reading, headache, concentration, work status, driving, sleep and recreation. Scoring for each question ranges from 0 to 5 (0: the best health state and 5: the worst health state). High scores in patients mean serious disability. Total point were scored between 0 (no disability) and 100 (complete disability)
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Mar 2018
- Primary completion1 Aug 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia, Cervical LordosisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 107 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408675
- Sponsor's protocol ID
- B.10.1.TKH.4.34.H.GP.0.01/146
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 14 May 2024
- Results posted
- 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loss of Cervical Lordosis an Association of Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT06408675
- Acronym / sponsor ID
- B.10.1.TKH.4.34.H.GP.0.01/146
- Conditions
- Fibromyalgia, Cervical Lordosis
- Keywords
- Fibromyalgia, cervical lordosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 10 May 2024 (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.
Purpose: The causes of chronic and widespread pain in fibromyalgia (FMS) have not been eluciated yet. Previous reports determined that posture control changed, muscle strength decreased, body posture misaligned (maladaptive posture), and functional capacity decreased in FMS patients. The aim of this study was to investigate the relationship between loss of cervical lordosis, pain, quality of life (QOL) and neck disability in patients with FMS.
Methods: A total of 107 FMS (88 females and 20 males; range of age:18-65) were included to the study. Patients were divided into two groups according to the angle of cervical lordosis measured by the Cobb method, group 1 with a Cobb angle of ≤10°, and group 2 with an angle greater than >10°. Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 with a Cobb angle of ≤10° | – | Other: Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.cervical lordosis cobb angele ≤10° |
| group 2 with an angle greater than >10° | – | Other: Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.cervical lordosis cobb angele >10° |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 107 patients who applied to the physical therapy and rehabilitation outpatient clinic; . Age range between 18-65 , male-female, Patients diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria
Key inclusion criteria (2 listed)
- Age range between 18 and 65
- -Patients diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria
Key exclusion criteria (9 listed)
- Patients diagnosed with known systemic (e.g., inflammatory rheumatic diseases, diabetes mellitus and systemic arterial hypertension), metabolic or endocrine diseasesas well as tumoral, neurologic or infectious diseases,
- Patients with a history of trauma and surgery affecting the neck area,
- Patients who received trigger point injection therapy for neck pain within the last 6 months,
- Patients with cervical disc herniation or myelopathy, spondylolisthesis, spondylolysis, cervicothoracic kyphoscoliosis,
- Patients who had been receiving therapy for any psychiatric diagnosis for the last 3 months and antidepressant drug use,
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 |
|---|---|---|
| Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively.Visual Analog Scale (VAS), QOL (36-Item Short Form Survey (SF-36)), and Neck Disability Index (NDI) were used to assess pain, overall quality of life, functional disability respectively. | Other | group 1 with a Cobb angle of ≤10°, group 2 with an angle greater than >10° |
Primary outcome
Visual analogue scale (VAS)
Time frame: day 1,
VAS scale used to measure the severity of pain (0-10 cm). According to this scale, the value 0 means no pain and the value 10 means very severe pain
2 secondary outcomes
Quality of Life Scale-Short Form (SF-36)
Time frame: day 1.
Neck disability index (NDI)
Time frame: day 1
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 14 May 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, Cervical Lordosis, run by Ankara City Hospital Bilkent at 2 sites 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 2 inclusion and 9 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Visual analogue scale (VAS) (time frame: day 1,). 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 14 May 2024.