Depression, Pain, Pes Planus, Quality of Life, Restless Legs Syndrome, Sleep Quality
Conditions
Keywords
Pes Planus, Restless Legs Syndrome, Sleep Disturbance, Foot Pain, Anxiety, Depression, Quality of Life, Foot Function
Brief summary
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.
Detailed description
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. Data collection included demographic information (age, sex, body mass index, educational status, smoking and alcohol use) and clinical variables (duration and severity of leg pain). The presence and severity of RLS were assessed using the International Restless Legs Syndrome Study Group Diagnostic Criteria and Severity Rating Scale, which are internationally recognized tools for diagnosis and quantification of symptom severity. Pain intensity and foot function were measured using the Visual Analog Scale and the Foot Function Index, respectively. Emotional status was evaluated by the Hospital Anxiety and Depression Scale. Sleep quality was assessed with the Pittsburgh Sleep Quality Index, and overall quality of life was measured by the Short Form-36 Health Survey. All assessments were performed by trained evaluators following a standardized protocol to ensure consistency across study sites. Data were collected through patient interviews, questionnaires, and clinical examinations. The primary objective was to determine the frequency of Restless Legs Syndrome among pes planus patients compared to healthy controls. Secondary objectives included evaluating the relationship between RLS severity and pain intensity, emotional status, sleep quality, and quality of life. This study aims to shed light on the complex interaction between biomechanical foot deformities and neurological symptoms, with the goal of informing comprehensive, multidisciplinary treatment approaches for patients with pes planus.
Interventions
None listed
Sponsors
Ankara Etlik City Hospital
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Bozok University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The International Restless Legs Syndrome Study Group Diagnostic Criteria | 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 | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Foot Function Index | At baseline | Foot function will be evaluated using the Foot Function Index, a 23-item questionnaire assessing three subdomains: pain, disability, and activity limitation. Each item is scored on a scale to quantify the impact of foot problems on daily activities. The total score reflects overall foot function impairment, with higher scores indicating greater dysfunction. The Turkish version of this scale has been validated for reliability and validity.Total Foot Function Index score and scores of subdomains (pain, disability, activity limitation) |
| The Hospital Anxiety and Depression Scale | At baseline | Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale, a 14-item self-report questionnaire consisting of two subscales: anxiety and depression. Each subscale includes 7 items scored to evaluate symptom severity. Scores of 8 or above on each subscale indicate clinically significant anxiety or depression. The scale has been validated in Turkish populations. Subscale scores for anxiety and depression; number and percentage of participants scoring 8 or above on each subscale |
| SF-36 | At baseline | Quality of life will be measured using the Short Form-36 (SF-36) Health Survey, a 36-item self-administered questionnaire assessing eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Each subscale is scored from 0 to 100, with higher scores indicating better perceived health status. The Turkish version of the SF-36 has been validated and is widely used in clinical research. Scores on each of the eight SF-36 subscales and composite physical and mental health scores |
Countries
Turkey (Türkiye)
Outcome results
None listed