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Central Sensitization and Nociplastic Pain in Pes Planus

CompletedNCT07125781
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Background: Pes planus, commonly known as flatfoot, is a condition characterized by the collapse of the medial longitudinal arch of the foot. While some individuals remain asymptomatic, many experience foot or leg pain, walking difficulties, and functional limitations. In some cases, symptoms persist despite adequate conventional treatment. This suggests that central pain mechanisms, such as central sensitization and nociplastic pain, may contribute to ongoing symptoms. These mechanisms involve changes in the central nervous system that amplify pain perception and can occur even in the absence of active tissue damage. Understanding these mechanisms in pes planus may help guide more targeted and effective treatment strategies. Purpose: The aim of this multicenter cross-sectional study was to determine the prevalence of central sensitization and nociplastic pain in individuals with clinically diagnosed pes planus and to compare the findings with age- and sex-matched healthy controls. Methods: Between November 2024 and May 2025, a total of 107 patients with pes planus and 107 healthy controls were recruited from three medical centers. Participants completed validated Turkish versions of the Visual Analog Scale for pain intensity, the Foot Function Index for functional limitation, the Pain-DETECT questionnaire for nociplastic pain symptoms, the Central Sensitization Inventory for central sensitization, the Hospital Anxiety and Depression Scale for psychological distress, and the Short Form-12 for quality of life. Data were analyzed using comparative statistical tests and multiple linear regression models to identify factors associated with nociplastic pain and central sensitization in the pes planus group.

Study details

Official title
Prevalence of Central Sensitization and Nociplastic Pain in Individuals Diagnosed With Pes Planus: A Multicenter Cross-Sectional Study
Conditions
Sponsor
Bozok University
Start date
2024-11-27
Primary completion
2025-05-31
Sex
All
Age range
from 18 Years to 65 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
Turkey (Türkiye)
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age between 18 and 65 years. * For pes planus group: clinically diagnosed pes planus confirmed by physical medicine and rehabilitation specialists, with persistent lower extremity pain for at least 6 months. * For control group: age- and sex-matched healthy volunteers without current or past foot or leg pain. * Willingness to complete all self-report questionnaires. * Provided written and verbal informed consent. Exclusion Criteria: * History of diabetes mellitus, hypothyroidism, malignancy, vasculitis, neuropathies, or lumbar radiculopathy. * History of lower limb surgery or trauma. * Recent local injection or extracorporeal shockwave therapy. * Any rheumatologic disease affecting pain perception (e.g., rheumatoid arthritis, ankylosing spondylitis). * Severe psychiatric disorder or cognitive impairment interfering with questionnaire completion.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07125781