Набор скоро начнётся NCT07043439

Comparison of the Immediate Effects of Mobilization and Manipulation Versus Sham Manipulation on Plantar Pressure in Patients With Hallux Valgus

Без фазы С лечением Hallux Valgus Foot Deformities Musculoskeletal Manipulations Plantar Pressure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Mobilization, High-Velocity Low-Amplitude (HVLA) Manipulation, Sham Manipulation.
Кому может быть актуально: Состояния в реестре: Hallux Valgus, Foot Deformities, Musculoskeletal Manipulations, Plantar Pressure. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The aim of this study is to examine the immediate effects of mobilization and manipulation versus sham manipulation on plantar pressure, quality of life, and pain in patients with hallux valgus. Participants will be assessed using a sociodemographic data form, the Manchester-Oxford Foot Questionnaire (MOXFQ), the Manchester Scale, goniometric measurements, the Multidimensional Nil Hallux Valgus Scale, the SF-36 Health Survey, the Numeric Pain Rating Scale (NPRS), and plantar pressure analysis via a pedobarographic device. The study will be conducted on a total of 60 feet, with 30 feet assigned to the manipulation group and 30 feet to the sham manipulation group.

Подробное описание

This is a single-center interventional study to be conducted at Diagenics R\&D Technology Health Import and Export Co. Ltd., aiming to explore the biomechanical impact of manual therapy techniques in individuals with hallux valgus. The study focuses on the immediate effects of first metatarsal mobilization and high-velocity, low-amplitude (HVLA) chiropractic manipulation, compared to a sham procedure, on plantar pressure distribution.

In the intervention group, participants will receive both grade 3 mobilization and HVLA manipulation targeted at the first metatarsophalangeal joint. The procedures will be carried out by a physiotherapist with the participant in a prone position and the foot held in neutral alignment.

The control group will receive a sham manipulation applied under identical positioning and handling conditions, but without therapeutic force or joint cavitation. This approach is designed to mimic the procedure while avoiding any real biomechanical impact. To eliminate ethical concerns regarding withholding effective treatment, participants in the control group will be offered the actual intervention after all immediate post-intervention data are collected.

All interventions and assessments will be conducted on a single day. Pre- and post-intervention plantar pressure data will be captured using a pedobarographic system. Pain intensity, joint angles, and other self-reported outcomes will be recorded using validated tools, but their details are provided in the corresponding modules.

The study's novelty lies in its integration of pedobarography for objective quantification of plantar pressure changes following isolated manual interventions, which may offer new insight into the acute mechanical responses of the foot in hallux valgus cases.

Вмешательства

Другое Mobilization
Participants receiving this intervention will undergo Grade 3 joint mobilization targeting the first metatarsophalangeal (1st MTP) joint. The technique will be administered by a licensed physiotherapist with the participant lying in the prone position and the foot in a neutral position. Mobilization will be performed according to the Maitland concept, which defines Grade 3 as large-amplitude, rhythmic oscillatory movements applied within the range of motion but up to the limit of tissue resista
Другое High-Velocity Low-Amplitude (HVLA) Manipulation
This intervention will involve the application of a high-velocity, low-amplitude (HVLA) thrust manipulation to the first metatarsophalangeal (1st MTP) joint. A licensed physiotherapist will perform the procedure with the participant positioned prone and the foot placed in a neutral alignment. The therapist will stabilize the 1st metatarsal bone with one hand and apply a quick, controlled thrust to the proximal phalanx of the hallux in a dorsal direction using the other hand. The technique will
Другое Sham Manipulation
Participants in the control group will receive a sham (placebo) intervention designed to mimic the real treatment in setup and duration, without applying any therapeutic mechanical stimulus. The sham procedure will be conducted by the same physiotherapist with participants lying prone and their foot in a neutral position. The physiotherapist will place their hands around the 1st MTP joint as if a manipulation were to be performed and will maintain static contact for the same duration as in the

Первичные конечные точки

Pedobarographic Analysis [Срок оценки: Baseline and immediately after the intervention (within the same session)]
Goniometric Measurement of 1st MTP Joint Range of Motion [Срок оценки: Baseline and immediately after the intervention (within the same session)]

Вторичные конечные точки (5)

Numeric Pain Rating Scale (NPRS) [Срок оценки: Baseline and immediately after the intervention (within the same session)]
Manchester-Oxford Foot Questionnaire (MOXFQ) [Срок оценки: Baseline and immediately after the intervention]
Manchester Scale for Hallux Valgus Severity [Срок оценки: Baseline and immediately after the intervention]
Multidimensional Nil Hallux Valgus Scale [Срок оценки: Baseline and immediately after the intervention]
SF-36 Short Form Health Survey [Срок оценки: Baseline and immediately after the intervention]

Критерии участия

Критерии включения

Be over 18 years of age
Volunteer to participate in the study
Have hallux valgus (those with a hallux valgus angle greater than 15 and a Manchester Scale score of B or higher)