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Craniovertebral AngleNCT06957873

Craniovertebral Angle and Fibromyalgia Severity

An observational study of Craniovertebral Angle and Fibromyalgia Syndrome, run by Ankara Training and Research Hospital at 3 sites in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Forward Head Posture Frequency in Fibromyalgia Patients Assessed by Craniovertebral Angle: Association with Symptom Severity. Forward head posture is more common in patients with fibromyalgia and is a factor that increases symptom severity. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Craniovertebral Angle, Fibromyalgia Syndrome
How many people
134 participants
Where
3 sitesTurkey (Türkiye)
Study dates
1 Apr 2025to 1 Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Our research will be conducted as a prospective study. The case group will consist of male and female patients aged 18-55 years who present to the Physical Medicine and Rehabilitation clinic with widespread pain complaints and are diagnosed with Fibromyalgia (FM) according to ACR 2010 diagnostic criteria. The control group, matched for age and gender distribution, will be selected from patients presenting with mechanical knee pain complaints and no cervical symptoms. Considering the increased likelihood of degenerative changes in the cervical region with advancing age, the investigators limited the upper age limit to 55 years. Demographic data will be collected through face-to-face interviews during examination. During this time, patients will complete the Fibromyalgia Impact Questionnaire (FIQ). The FIQ is a 10-item questionnaire that evaluates the severity of fibromyalgia symptoms.

Who may be able to join

  • Aged 18-55 years
  • Diagnosed with Fibromyalgia (FM) according to The American College of Rheumatology (ACR) 2010 Diagnostic Criteria for Fibromyalgia

Who cannot join

  • History of past or current pathology in the cervical spine, thoracic spine, or upper extremities
  • History of paraspinal or thoracic surgery involving the head, spine, or shoulders within the last six months
  • Structural spinal malformation
  • History of surgical or neurological disorders
  • Cervical trauma or pain treatment within the last 6 months
  • Temporomandibular surgery
  • Psychiatric disorders (e.g., dementia, amnesia, or delirium)
  • Systemic inflammatory rheumatic diseases

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nadide Koca, M.D. contact

+905376843434

nadide.koca@gmail.com

Hakan Genç, PROF. M.D. contact

00905359780666

nadide.koca@gmail.com

Turkey (Türkiye)3 sites, 2 recruiting
  • Ankara Training and Research Hospital Ankara, Altindag, Turkey, 06230

    Ankara, Altindag, 06230

    Nadide Koca, 05376843434, nadide.koca@gmail.com

    Recruiting
  • Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

    Ankara, Altindag, 06230

    Completed
  • University of Health Sciences, Ankara Training and Research Hospital

    Ankara, Altindag, 06230

    Enrolling by invitation

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Relationship Between Craniovertebral Angle and Fibromyalgia Symptom Severity

Forward Head Posture Frequency in Fibromyalgia Patients Assessed by Craniovertebral Angle: Association with Symptom Severity. Forward head posture is more common in patients with fibromyalgia and is a factor that increases symptom severity.

Read the detailed description

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread musculoskeletal pain, muscle stiffness, joint rigidity, insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, depression, and general hypersensitivity.

Fibromyalgia is considered a central sensitivity syndrome. Central sensitization refers to a neuronal signal amplification mechanism within the central nervous system that leads to enhanced pain perception. Consequently, patients with FM exhibit an increased receptive field of pain, allodynia, and hyperalgesia.

Headache and temporomandibular disorders (TMD) are among the most common comorbidities in FM, displaying overlapping clinical and pathophysiological features.

Nociplastic pain is defined by the International Association for the Study of Pain as pain arising from altered nociception despite no clear evidence of actual or threatened tissue damage causing the activation of peripheral nociceptors or evidence for disease or lesion of the somatosensory system causing the pain. The mechanism of nociplastic pain is proposed to involve increased central nervous system sensitization and impaired sensory processing, accompanied by altered pain modulation. Definitive criteria for nociplastic pain have not yet been established. Eight specific disorders associated with central sensitization have been proposed: restless leg syndrome, chronic fatigue syndrome, FM, TMD, migraine or tension-type headache (TTH), irritable bowel syndrome, multiple chemical sensitivities, and whiplash injury.

Central sensitization is classically defined as a consequence of ongoing nociceptive inputs in chronic pain conditions. Its development is reported to be influenced by genetic factors, pain processing disorders in the brain, neuroendocrine and autonomic abnormalities, abnormal cytokines, and immune dysfunction.

As evident, conditions frequently accompanying FM, such as migraine, tension-type headache, chronic fatigue, irritable bowel syndrome, and TMD, share overlapping pathophysiology related to central sensitization.

A bidirectional relationship has been reported between primary headaches and craniocervical postural disorder, defined as Forward Head Posture (FHP). Postural disorders generate nociceptive peripheral stimuli that may lead to sensitization in the trigeminocervical complex.

The trigeminocervical complex (TCC), located in the brainstem, is a common convergence pathway where both trigeminal (dural) and cervical (primarily via the greater occipital nerve) afferent inputs are projected to higher centers in the thalamus and cortex. The TCC serves as the first sensory relay for meningeal and cephalic cutaneous information and forms the pathways for referred pain in primary headaches.

Brainstem interneurons have been shown to play a key role in pain modulation in migraine, TTH, and cluster headaches. Primary headache has been determined to result from trigeminocervical complex dysfunction. Neurophysiological studies on trigeminal reflexes support the concept of primary brainstem dysfunction and central hyperexcitability of trigeminal sensory pathways in chronic pain syndromes such as FM and TTH.

Similarly, animal studies in FM have identified a hyperalgesic state in the trigeminal region.

Sensitization in the trigeminocervical complex can lead to central sensitization by increasing thalamic and cortical stimulation. Peripheral and central sensitization are characterized by widespread hyperalgesia and allodynia. Consequently, patients with chronic primary headache exhibit a larger pain distribution area not only in the craniocervical region but throughout the entire spine.

The relationship between TCC sensitization and pain disorders has been well-documented in human and animal studies. Significant abnormalities in TCC responses have been observed in patients with trigeminal neuralgia, migraine, cluster headache, chronic tension-type headache, and fibromyalgia, attributed to hyperexcitability of trigeminal pathways.

Similarly, TMD, another comorbidity accompanying FM, frequently co-occurs with primary headaches, and the trigeminal system is reported to be the common pathophysiological mechanism.

Forward Head Posture (FHP) refers to the anterior displacement of the head relative to the trunk through upper cervical extension and lower cervical flexion. A craniovertebral angle (CVA) of 49° or less is defined as FHP.

FHP, characterized by forward head projection and rounded shoulders, is a common consequence of modern lifestyles involving prolonged use of laptops, mobile devices, or driving. It leads to persistent headache and is associated with migraine, TTH, and cervicogenic headaches.

The relationship between TMD and FHP is well-established. Forward head posture leads to TMD.

In the pathophysiology of primary headaches and TMD, which frequently accompany FM, the trigeminocervical complex emerges as a factor increasing central sensitization. FHP is reported to be a postural factor contributing to this. Central sensitization also plays a primary role in FM pathophysiology.

Postural studies in FM have reported increased thoracic kyphosis, lower CVA, and impaired cervical joint position sense.

To our knowledge, there are no studies examining the relationship between craniovertebral angle and disease severity in FM. We hypothesize that FHP may play a significant role in central sensitization in FM patients through the trigeminocervical complex, similar to its role in headaches and TMD. Therefore, we aim to investigate the frequency of FHP in FM patients and its relationship with FM disease severity.

Keywords
Fibromyalgia Syndrome, craniovertebral angle
Medical subject headings
Fibromyalgia

What participants receive

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

Study groups in NCT06957873
Study groupRoleWhat they receive
Fibromyalgia GroupFibromyalgia (FM) is a chronic pain syndrome characterized by widespread musculoskeletal pain, muscle stiffness, joint stiffness, insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, depression, and general sensitivity. Female and male patients between the ages of 18-55 who are diagnosed with FM according to the ACR 2010 diagnostic criteria will constitute the case group.
Control GroupThe control group, matching similar age and gender distribution, will be selected from patients presenting with mechanical knee pain complaints and without neck complaints. Considering the increased likelihood of degenerative changes in the cervical region with advancing age, the investigators limited the upper age limit to 55.

What is being measured

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

  1. The craniovertebral angle

    During the same visit, permission will be obtained from patients for photography, and it will be explained that the photograph will be used solely for scientific research. One lateral photograph will be taken from consenting patients. For this purpose, the patient will be instructed to assume a standing posture and then relax. After the photographs taken with the camera placed at shoulder level are printed, the craniovertebral angle representing the forward head posture will be measured. The craniovertebral angle is the angle between the horizontal line passing through the 7th cervical vertebra and the line connecting the tragus of the ear to the C7 spinous process. The craniovertebral angle value will be calculated as the average value measured 5 times.

    Measured: up to 12 weeks

Secondary outcomes (1)
  1. Fibromyalgia Impact Questionnaire

    The Fibromyalgia Impact Questionnaire (FIQ) consists of 10 items. The first item contains 11 questions related to physical function - each question is rated on a 4-point Likert-type scale. Items 2 and 3 ask the patient to mark the number of days they felt well and the number of days they could not work (including housework) due to fibromyalgia symptoms. Items 4 through 10 are horizontal linear scales marked in increments of 10 on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The highest possible score for each of the 10 items is 10, thus the highest possible score is 100. The average FM patient scores approximately 50 points; severely affected patients typically score ≥70 points.

    Measured: up to 12 weeks

Timeline

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

  1. First posted5 May 2025
  2. Study start1 Apr 2025
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

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
Prospective
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06957873
Sponsor's protocol ID
AnkaraTRH-FTR-NK-06
Status last verified
Sep 2026
First submitted
27 Apr 2025
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Graff-Radford SB, Abbott JJ. Temporomandibular Disorders and Headache. Oral Maxillofac Surg Clin North Am. 2016 Aug;28(3):335-49. doi: 10.1016/j.coms.2016.03.004.

    PubMed 27475510
  • Abanoz Y, Gulen Abanoz Y, Gunduz A, Karadeniz D, Erdemir Kiziltan M. Long latency trigemino-cervical reflex in restless legs syndrome. Int J Neurosci. 2024 Aug;134(8):924-930. doi: 10.1080/00207454.2022.2158826. Epub 2022 Dec 28.

    PubMed 36533413
  • Deodato M, Granato A, Del Frate J, Martini M, Manganotti P. Differences in musculoskeletal dysfunctions and in postural alterations between chronic migraine and chronic tension type headache: A cross-sectional study. J Bodyw Mov Ther. 2024 Jan;37:404-411. doi: 10.1016/j.jbmt.2023.11.011. Epub 2023 Nov 17.

    PubMed 38432837
  • Nazeri M, Zarei MR, Pourzare AR, Ghahreh-Chahi HR, Abareghi F, Shabani M. Evidence of Altered Trigeminal Nociception in an Animal Model of Fibromyalgia. Pain Med. 2018 Feb 1;19(2):328-335. doi: 10.1093/pm/pnx114.

    PubMed 28505350
  • Wodehouse T, Bahra A, Mehta V. Changes in peripheral and central sensitization in patients undergoing occipital nerve stimulation. Br J Pain. 2020 Nov;14(4):250-255. doi: 10.1177/2049463719860548. Epub 2019 Jul 29.

    PubMed 33194189
  • Caponnetto V, Deodato M, Robotti M, Koutsokera M, Pozzilli V, Galati C, Nocera G, De Matteis E, De Vanna G, Fellini E, Halili G, Martinelli D, Nalli G, Serratore S, Tramacere I, Martelletti P, Raggi A; European Headache Federation School of Advanced Studies (EHF-SAS). Comorbidities of primary headache disorders: a literature review with meta-analysis. J Headache Pain. 2021 Jul 14;22(1):71. doi: 10.1186/s10194-021-01281-z.

    PubMed 34261435
  • Liang Z, Galea O, Thomas L, Jull G, Treleaven J. Cervical musculoskeletal impairments in migraine and tension type headache: A systematic review and meta-analysis. Musculoskelet Sci Pract. 2019 Jul;42:67-83. doi: 10.1016/j.msksp.2019.04.007. Epub 2019 Apr 25.

    PubMed 31054485
  • Ji RR, Nackley A, Huh Y, Terrando N, Maixner W. Neuroinflammation and Central Sensitization in Chronic and Widespread Pain. Anesthesiology. 2018 Aug;129(2):343-366. doi: 10.1097/ALN.0000000000002130.

    PubMed 29462012
  • Yoo YM, Kim KH. Current understanding of nociplastic pain. Korean J Pain. 2024 Apr 1;37(2):107-118. doi: 10.3344/kjp.23326. Epub 2024 Mar 20.

    PubMed 38504389
  • Yakkaphan P, Smith JG, Chana P, Tan HL, Ravindranath PT, Lambru G, Renton T. Temporomandibular Disorders and Fibromyalgia Prevalence: A Systematic Review and Meta-Analysis. J Oral Facial Pain Headache. 2023 Nov 17;37(3):177-193. doi: 10.11607/ofph.3260.

    PubMed 37975782
  • Lee W, Shin HJ, Min IK, Kim CS, Kim KM, Heo K, Chu MK. Shared comorbidity of depression, migraine, insomnia, and fibromyalgia in a population-based sample. J Affect Disord. 2024 Jun 1;354:619-626. doi: 10.1016/j.jad.2024.03.077. Epub 2024 Mar 15.

    PubMed 38494140
  • Siracusa R, Paola RD, Cuzzocrea S, Impellizzeri D. Fibromyalgia: Pathogenesis, Mechanisms, Diagnosis and Treatment Options Update. Int J Mol Sci. 2021 Apr 9;22(8):3891. doi: 10.3390/ijms22083891.

    PubMed 33918736
  • de Tommaso M, Vecchio E, Nolano M. The puzzle of fibromyalgia between central sensitization syndrome and small fiber neuropathy: a narrative review on neurophysiological and morphological evidence. Neurol Sci. 2022 Mar;43(3):1667-1684. doi: 10.1007/s10072-021-05806-x. Epub 2022 Jan 14.

    PubMed 35028777
  • Oton T, Carmona L, Rivera J. Patient-journey of fibromyalgia patients: A scoping review. Reumatol Clin (Engl Ed). 2024 Feb;20(2):96-103. doi: 10.1016/j.reumae.2023.07.005.

    PubMed 38395498

Questions about this trial

What is this clinical trial studying?

An observational study of Craniovertebral Angle and Fibromyalgia Syndrome, run by Ankara Training and Research Hospital at 3 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 8 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Nadide Koca, M.D. (+905376843434, nadide.koca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The craniovertebral angle (time frame: up to 12 weeks). 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 NCT06957873, which also lists 14 linked publications.

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 9 Sep 2026.

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