Restless Legs Syndrome and Sleep Quality in Pes Planus (FLAT-RLS)

Bozok University

Status: Completed

Conditions: Pes Planus; Quality of Life; Sleep Quality; Depression; Restless Legs Syndrome; Pain

Study type: Observational

Funder types: Other

Identifiers

NCT07117591

2024/21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 242 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

242 participants in 2 patient groups

Patient group

Description:

Participants in this group were clinically diagnosed with pes planus (flatfoot) by a physical medicine and rehabilitation specialist, based on physical examination findings. Individuals were aged between 18 and 65 years and presented with lower extremity pain. No intervention was applied. This group was evaluated using standardized questionnaires to assess the presence and severity of Restless Legs Syndrome, pain levels, emotional status, sleep quality, and quality of life.

the Control group

Description:

This group included healthy volunteers between the ages of 18 and 65 who had no clinical signs of pes planus or lower extremity pain. Participants were matched to the patient group by age and sex. No medical or rehabilitative intervention was applied. They were evaluated using the same standardized tools to assess the presence of Restless Legs Syndrome, emotional status, sleep quality, and quality of life, for comparison with the patient group.