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临床试验/NCT06957873
NCT06957873招募中不适用

Evaluation of the Relationship Between Craniovertebral Angle and Fibromyalgia Symptom Severity

Ankara Training and Research Hospital3 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2025年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
134
试验地点
3
主要终点
The craniovertebral angle

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

结局指标

主要结局

The craniovertebral angle

时间窗: 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.

次要结局

  • Fibromyalgia Impact Questionnaire(up to 12 weeks)

研究者

发起方
Ankara Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadide Koca

Physical Medicine & Rehabilitation Specialist

Ankara Training and Research Hospital

研究点 (3)

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