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Идёт набор NCT02890485

The Effects of Dry Needling on Patients With Knee Pain

Без фазы С лечением Patellofemoral Pain Syndrome Anterior Knee Pain Syndrome

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: Dry Needling, Sham Dry Needling, Physical Therapy.
Кому может быть актуально
Состояния в реестре: Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome. Базовые параметры: 18 лет — 40 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study is testing the effectiveness of "dry needling" for pain management and on muscle strength and leg function for those with knee pain. Dry needling consists of small, monofilament needles that are administered directly into the tissue and manipulated to make the muscle relax for pain relief. This technique is used to treat dysfunctions in skeletal muscle and connective tissue to help diminish pain, reduce impairments of body structure and restore function.

Подробное описание

This project will evaluate the effects of dry needling on pain, muscle performance, and function in those with patellofemoral pain syndrome (PFPS) of the knee. Variables of interest will include self-reported pain scores, self-reported functional outcome and disability questionnaire scores, and various objective clinical measures including muscle strength, joint range of motion, and movement patterns during basic tasks related to activities of daily living. Patients who are referred to physical therapy with PFPS will be recruited. Patients will be randomly and equally allocated into one of the following groups: 1. Gluteal dry needling (GLUTE) 2. Quadriceps dry needling (QUAD) 3. Sham gluteal dry needling (SHAM GLUTE) 4. Sham quadriceps dry needling (SHAM QUAD) 5. Control group (CONTROL) Groups 1-4 will receive 2 sessions of dry needling or sham dry needling to the gluteal and/or quadricpes muscles on their painful lower limb over 2 consecutive weeks in addition to standard physical therapy. The CONTROL group will only receive standard physical therapy. The sham treatment groups (groups 3-4) will receive a placebo treatment that does not penetrate the skin or muscles. Measurements will be performed at baseline prior to any physical therapy interventions and then at week 3.

Вмешательства

  • Устройство Dry Needling
    Dry needling consists of small, monofilament needles that are administered directly into the tissue and manipulated to make the muscle relax for pain relief. This technique is used to treat dysfunctions in skeletal muscle and connective tissue to help diminish pain, reduce impairments of body structure and restore function. Dry needling will be performed in the gluteal or the quadriceps muscle groups depending upon group randomization.
  • Устройство Sham Dry Needling
    The same overall procedures will be used as in the "true" dry needling groups and applied to the same muscle groups (gluteal or quadriceps) depending upon ground randomization. Sham dry needling will be performed using a commercially available sham needling system commonly.This set-up utilizes a blunt tipped needle. When the sham needle is pressed downward, the barrel of the needle retracts into the handle, giving the appearance of insertion of the needle through the skin. This also creates pres
  • Другое Physical Therapy
    Physical Therapy and exercise as determined by the examining clinician based on the patients specific impairments and functional limitations. All subjects enrolled in this study will receive an initial physical therapy (PT) evaluation and then 2 additional PT sessions a week a part. Interventions and prescribed home exercises will be specific to the patients' primary individual impairments as determined during the initial PT evaluation. These interventions reflect current evidence, but will not

Первичные конечные точки

  • Change from Baseline Anterior Knee Pain Scale (AKPS) score to 3 weeks [Срок оценки: Baseline and Post testing (week 3)]
  • Change from Baseline Numeric Pain Rating Scale (NPRS) score to 3 weeks [Срок оценки: Baseline and Post testing (week 3)]
Вторичные конечные точки (4)
  • Change from Baseline Lateral step-down (LSD) test score to 3 weeks [Срок оценки: Baseline and Post testing (week 3)]
  • Change from Baseline Isometric knee and hip peak torque values to 3 weeks [Срок оценки: Baseline and Post testing (week 3)]
  • Change from Baseline Lower Extremity Functional Scale (LEFS) score to 3 weeks [Срок оценки: Baseline and Post testing (week 3)]
  • Change from Baseline Pressure Pain Threshold to 3 weeks [Срок оценки: Baseline and Post testing (week 3)]

Критерии участия

Критерии включения

  • 18-40 years-of-age
  • Referred for physical therapy
  • Presence of anterior knee pain around the patella during ascending/descending stairs, squatting, and/or running for at least 3 months.

Критерии исключения

  • Unable to provide consent
  • Bilateral patellofemoral pain syndrome
  • Received previous dry needling treatments
  • Pregnancy
  • History of pain less than 3 months
  • Imaging demonstrating the presence of confounding internal abnormality (e.g. chondral defects, ligamentous injury, and/or meniscal pathology),
  • Patellar instability
  • Presence of a neurological condition that would affect movement
  • Contraindications to dry needling techniques (e.g. a history of bleeding disorders, phobia of needles, an active cancer diagnosis, and presence of other systemic illness such as fever or signs of infection)
  • Actively receiving treatment for knee pain outside of the current study protocol while enrolled in the study;
  • received active and supervised PT treatment for knee pain within the last 4 weeks;
  • history of knee surgery less than 6 months ago
  • history of surgical correction of the patellofemoral complex (e.g. MPFL reconstruction, patellar realignment surgery, etc)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • The Ohio State University Wexner Medical Center — Columbus

Идентификаторы

NCT: NCT02890485 · 2016H0003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗