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Clinical Trials/NCT06957873
NCT06957873RecruitingNot Applicable

Evaluation of the Relationship Between Craniovertebral Angle and Fibromyalgia Symptom Severity

Ankara Training and Research Hospital3 sites in 1 country134 target enrollmentStarted: April 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
134
Locations
3
Primary Endpoint
The craniovertebral angle

Study Overview

Brief 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.

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

Control Group

The 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.

Fibromyalgia Group

Fibromyalgia (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.

Outcomes

Primary Outcomes

The craniovertebral angle

Time Frame: up to 12 weeks

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.

Secondary Outcomes

  • Fibromyalgia Impact Questionnaire(up to 12 weeks)

Investigators

Sponsor
Ankara Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nadide Koca

Physical Medicine & Rehabilitation Specialist

Ankara Training and Research Hospital

Study Sites (3)

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