Frequency of Restless Legs Syndrome and Its Impact on Sleep Quality in Patients With Pes Planus: A Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- The International Restless Legs Syndrome Study Group Diagnostic Criteria
研究概览
简要总结
Pes planus, also known as flatfoot, is a common foot deformity that can affect the biomechanics of the lower limbs. However, its relationship with neurological conditions has not been studied extensively. Restless Legs Syndrome is a neurological disorder characterized by uncomfortable sensations in the legs and an urge to move them, especially during periods of rest, which can negatively affect sleep quality.
The aim of this multicenter cross-sectional study, conducted at Etlik Zübeyde Hanım Women's Health Training and Research Hospital, Etlik City Hospital in Ankara, and Yozgat City Hospital, is to determine the frequency of Restless Legs Syndrome in patients diagnosed with pes planus and to examine its effects on pain, emotional status, sleep quality, and quality of life. The study included 122 patients aged between 18 and 65 years with clinically diagnosed pes planus, and 120 healthy individuals matched for age and sex. Participants were assessed using the International Restless Legs Syndrome Study Group Diagnostic Criteria and Severity Rating Scale for Restless Legs Syndrome, the Visual Analog Scale and Foot Function Index for pain and foot function, the Hospital Anxiety and Depression Scale for emotional status, the Pittsburgh Sleep Quality Index for sleep quality, and the Short Form-36 Health Survey for quality of life.
详细描述
Pes planus, commonly known as flatfoot, is a frequent foot deformity characterized by a lowered medial longitudinal arch, which can affect lower limb biomechanics and overall posture. While its mechanical effects on the musculoskeletal system have been widely studied, the potential neurological and psychosocial implications of pes planus remain insufficiently explored.
Restless Legs Syndrome (RLS) is a neurological disorder marked by an uncontrollable urge to move the legs, often accompanied by unpleasant sensations. Symptoms typically worsen during rest or inactivity and can lead to significant sleep disturbances and reduced quality of life.
This multicenter cross-sectional observational study was designed to investigate the prevalence of RLS among patients clinically diagnosed with pes planus, and to evaluate the impact of RLS on pain severity, emotional well-being, sleep quality, and overall health-related quality of life.
The study was conducted between December 2024 and July 2025 at three tertiary care centers: Etlik Zübeyde Hanım Women's Health Training and Research Hospital, Etlik City Hospital in Ankara, and Yozgat City Hospital. A total of 242 participants were recruited, including 122 patients with clinically confirmed pes planus and 120 age- and sex-matched healthy controls without foot deformities or leg pain.
Inclusion criteria for patients were age between 18 and 65 years and a clinical diagnosis of pes planus by a physical medicine and rehabilitation specialist, based on physical examination. Exclusion criteria included the presence of systemic diseases such as diabetes mellitus, hypothyroidism, chronic renal failure, neuropathies, rheumatological conditions, history of foot surgery or fractures, and other conditions potentially affecting pain perception or neurological status.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years
- •Clinical diagnosis of pes planus by a physical medicine and rehabilitation specialist (for patient group)
- •Ability to understand and provide written informed consent
- •For control group: healthy individuals matched by age and sex without pes planus or leg pain
排除标准
- •History of diabetes mellitus, hypothyroidism, chronic renal failure, neuropathic disorders, vasculitis, lumbar disc disease
- •Previous foot fracture or surgery
- •Rheumatologic diseases affecting pain perception (e.g., rheumatoid arthritis, ankylosing spondylitis, fibromyalgia)
- •Significant circulatory disorders in lower extremities
- •Undergoing chemotherapy or radiotherapy
- •Cognitive impairment preventing questionnaire completion
结局指标
主要结局
The International Restless Legs Syndrome Study Group Diagnostic Criteria
时间窗: At baseline
Restless Legs Syndrome will be diagnosed using the International Restless Legs Syndrome Study Group Diagnostic Criteria, which consist of five essential clinical criteria. All criteria must be met for diagnosis. These include: (1) an urge to move the legs; (2) symptoms that begin or worsen during rest or inactivity; (3) symptoms relieved by movement; (4) symptoms worse in the evening or at night; and (5) symptoms not solely accounted for by another medical or behavioral condition.This tool, originally developed in 1995 and revised in 2014, includes five essential diagnostic criteria and is based solely on clinical history. All criteria must be met for a diagnosis of restless legs syndrome
The International Restless Legs Syndrome Study Group Criteria Severity Rating Scale
时间窗: At baseline
The severity of Restless Legs Syndrome symptoms will be assessed using the International Restless Legs Syndrome Study Group Severity Rating Scale. This is a validated 10-item questionnaire that evaluates symptom intensity, frequency, sleep disruption, and the psychosocial impact of Restless Legs Syndrome. Each item is scored from 0 to 4, with total scores ranging from 0 to 40. Severity is categorized as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40). The scale has been validated for use in Turkish populations.Total severity score (range 0-40) and severity category distribution (mild/moderate/severe/very severe).
The Pittsburg Sleep Quality Index
时间窗: At baseline
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, a 24-item self-reported questionnaire that evaluates sleep quality and disturbances over the past month. Scores range from 0 to 21, with higher scores indicating poorer sleep quality. A total score of 5 or above is used to define poor sleep quality. The index has been validated in Turkish populations.Total Pittsburgh Sleep Quality Index score and proportion of participants classified as poor sleepers (score ≥5)
次要结局
- The Foot Function Index(At baseline)
- The Hospital Anxiety and Depression Scale(At baseline)
- SF-36(At baseline)
研究者
Gulseren Demir Karakilic
Assistant Professor, Principal Investigator
Bozok University