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临床试验/NCT07378917
NCT07378917已完成不适用

Evaluation of Metatarsophalangeal Joint Alignment in Mild and Moderate Hallux Abducto Valgus Through Orthotic Intervention

University of Valencia1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年11月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Radiographic Valgus Angle Correction

研究概览

简要总结

This study aims to evaluate the effectiveness of an external corrector in realigning the first metatarsophalangeal joint in patients with mild to moderate Hallux Abducto Valgus, according to the Manchester scale. Changes in valgus angle will be assessed through radiographs, along with pain, comfort and adherence, comparing results with a control group.

详细描述

Introduction and Rationale Hallux Abducto Valgus (HAV) is the most common forefoot deformity, often associated with pain and functional limitations. Its development is multifactorial, and although surgical and conservative treatments exist, evidence regarding the real effectiveness of corrective orthopedic devices in early stages is scarce. This study seeks to provide scientific rigor to a device frequently recommended in clinical practice by evaluating its ability to correct alignment and improve symptoms.

Main and Secondary Objectives The primary objective is to assess the effectiveness of the corrector in realigning the first toe by measuring the valgus angle radiographically at three time points: without the corrector, immediately after application, and after 3 months. Secondary objectives include evaluating pain (VAS), comfort, adherence, device fit, changes in plantar pressure (static and dynamic), patient satisfaction, and differences compared to the control group.

Study Design and Population This is an experimental study involving a group of 35 subjects diagnosed with mild or moderate HAV according to the Manchester scale, recruited at the Aquilesia podiatry clinic (Vila-real, Castelló). Recruitment will be carried out through local media, social networks, and referrals from healthcare professionals. Informed consent, anonymity, and compliance with data protection regulations will be ensured.

Intervention and Measurements The intervention consists of applying an external hallux alignment corrector. Three radiographic measurements of the metatarsophalangeal angle will be taken: baseline, after corrector placement, and at 3 months. Additional data will include pain, comfort, adherence and device adjustment. Standardized scales (VAS, satisfaction questionnaires) and Excel-based data recording will be used.

Data Processing and Analysis Data will be collected by a podiatrist and anonymized before analysis. Intra- and intergroup differences will be evaluated using appropriate statistical tests, considering variables such as sex, age, and degree of deformity. The study aims to determine whether the corrector produces significant improvements in alignment and other clinical parameters, providing evidence for its usefulness in podiatric practice.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sex: Male or female Age: 18 to 80 years Cooperative subject, informed of the need and duration of follow-up visits, ensuring full compliance with the protocol/study, and having signed informed consent No previous surgery on the foot and/or ankle Mild and/or moderate Hallux Valgus (Manchester Scale)

排除标准

  • Patient with severe arteriopathy Patient with severe edema Patient with sensory neuropathy Patients who have used additional pharmacological treatments (analgesics/anti-inflammatories) during the entire study period Severe Hallux Valgus (Manchester Scale) Any systemic disease affecting the musculoskeletal system Rheumatoid arthritis involving the first metatarsophalangeal joint Instability of the first metatarsophalangeal joint History of previous foot and/or ankle surgery Hyperpronated foot with FPI >10 Severe pathological genu varum or valgum Pregnant women or suspected pregnancy

研究组 & 干预措施

Orthosis

Experimental

The study group will consist of 35 adult subjects, both men and women, diagnosed with mild to moderate Hallux Abducto Valgus (HAV) according to the Manchester scale.

干预措施: Hallux Valgus Orthosis (Device)

结局指标

主要结局

Radiographic Valgus Angle Correction

时间窗: 3 months

Measurement of the hallux valgus angle on digital radiographs at baseline and after 3 months of orthosis use, to determine the degree of realignment of the first metatarsophalangeal joint.

次要结局

  • Pain Assessment (VAS)(3 months)
  • Comfort and Satisfaction(3 months)
  • Device Fit and Adjustment(1day)
  • Orthosis Condition After Use(3 months)
  • Adherence to Treatment(3 months)
  • Purchase Decision(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

CARMEN GARCÍA GOMARIZ

Associate Professor of Infirmary

University of Valencia

研究点 (1)

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