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Набор скоро начнётся NCT06891001

The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, Biomechanics, and Pain Intensity

Без фазы С лечением Gluteus Medius Muscle Strength Lateral Hip Pain Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy

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: Unilateral neutral shoe insert, Bilateral Shoe Insert, Physical Therapy.
Кому может быть актуально
Состояния в реестре: Gluteus Medius Muscle Strength, Lateral Hip Pain, Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy. Базовые параметры: 18 лет — 70 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
США
Следующий шаг
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Обзор

We hypothesize that the addition of a unilateral neutral shoe insert combined with standard physical therapy (PT+SI) will have greater improvements in pain and function at 12 weeks and 6 months compared to physical therapy with sham inserts (PT+Sham) and physical therapy (PT) alone. In addition, we hypothesize that the addition of a neutral shoe insert in the involved limb will immediately improve biomechanics and pain with the single-leg stance test.

Вмешательства

  • Устройство Unilateral neutral shoe insert
    In the treatment group, subjects will undergo the addition of a neutral shoe insert to the involved lower extremity according to manufacturer guidelines at the initial visit. These subjects will also undergo a once-weekly 12-week course of physical therapy according to the established standardized protocol.
  • Устройство Bilateral Shoe Insert
    For subjects placed in the sham group, subjects will undergo the addition of a neutral shoe insert to both lower extremities according to manufacturer guidelines at the initial visit. These subjects will also undergo a once-weekly 12-week course of physical therapy according to the established standardized protocol with guidelines .
  • Другое Physical Therapy
    For subjects placed in the control group, subjects will undergo a once-weekly 12-week course of physical therapy according to the established standardized protocol.

Первичные конечные точки

  • Victorian Institute Sport Assessment - Gluteal Questionnaire [Срок оценки: 12 weeks]
Вторичные конечные точки (5)
  • Visual Analog Scale for Pain [Срок оценки: 12 weeks]
  • Global Rating of Change Scale [Срок оценки: 12 weeks]
  • Isometric Hip Strength [Срок оценки: 12 weeks]
  • Single Leg Stance for Pain [Срок оценки: 12 weeks]
  • Single Leg Stance Biomechanics [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Subjects with a history of unilateral hip pain lasting more than three months.
  • Subjects with a VAS pain score of at least 3/10 localized to the lateral hip.
  • Subjects with pain with palpation to lateral hip.
  • Subjects with pain with either resisted hip abduction in relative adduction testing position and/or single leg stance test

Критерии исключения

  • Subjects wearing custom foot orthoses at the time of recruitment.
  • Subjects who endorse current low back pain ≥ 3 on the NRS or lumbar radiculopathy
  • Subjects with a medical history of spinal or lower limb surgery in the past 6 months.
  • Subjects with a medical history of total joint replacement of hip, knee, or ankle on the symptomatic side
  • Subjects who have had a corticosteroid injection at the hip within the last 12 months;
  • Subjects demonstrating clinical signs and symptoms of intra-articular hip joint pathology with ≥ 3/10 groin pain including imaging confirmed significant labral tearing requiring surgery or osteoarthritis > 2 (mild) on Kellgren-Lawrence score on radiographs.
  • Subjects previously diagnosed with systemic inflammatory conditions; active cancer/malignant tumors; or neurological conditions that would affect gait
  • Subjects who have had physical therapy within the past 3 months for hip pain
  • If subjects are unable to commit to 12 weeks of therapy with one supervised session weekly
  • Subjects who have the intention to perform treatments outside of this study including, but not limited to, dry needling or acupuncture, extracorporeal shockwave, therapeutic ultrasound, a TENEX procedure, medication injection therapies, platelet-rich plasma injections, stem cell injections, and surgery.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Mayo Clinic — Glendale

Идентификаторы

NCT: NCT06891001 · 24-011290

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗