Pulsed Radiofrequency Versus 5% Dextrose Injection in Chronic Plantar Fasciitis
Comparison of Ultrasound-Guided Pulsed Radiofrequency and 5% Dextrose Injection in Patients With Chronic Plantar Fasciitis: A Randomized Controlled Trial
Обзор исследования
Статус
Подробное описание
Plantar fasciitis is one of the most common causes of chronic heel pain in adults. It may impair walking pattern, daily activities, social life, and work-related functioning. Although conservative treatments are commonly used as first-line therapy, symptoms may become chronic in a considerable proportion of patients.
Dextrose injection is a regenerative injection treatment used in chronic musculoskeletal pain conditions. It is thought to stimulate local tissue healing responses through controlled inflammatory and proliferative mechanisms. Pulsed radiofrequency is a minimally invasive, non-neurodestructive radiofrequency technique used for pain control. Both pulsed radiofrequency and dextrose injection are used in clinical practice for resistant chronic plantar fasciitis; however, comparative data between these two approaches are limited.
This study will be conducted as a prospective, two-center, two-arm, parallel-group randomized controlled trial in the Physical Medicine and Rehabilitation clinics of Ankara Bilkent City Hospital and Adana City Hospital. Participants with chronic plantar fasciitis will be randomized in a 1:1 ratio using the sealed-envelope method. The investigator responsible for randomization will know the allocation, while the outcomes assessor will be blinded to treatment allocation. Blinding of the interventionists will not be possible due to the nature of the procedures.
Participants in the pulsed radiofrequency group will receive ultrasound-guided pulsed radiofrequency treatment at baseline. Participants in the 5% dextrose group will receive ultrasound-guided 5% dextrose injection around the medial calcaneal insertion of the plantar fascia using the peppering technique, with 0.1-0.2 mL administered at each entry point. Dextrose injections will be performed in three sessions at 3-week intervals.
All participants will receive a home-based plantar fascia stretching exercise program. Exercises will be demonstrated by a physiotherapist, and participants will be instructed to perform the exercises twice daily for 12 weeks. Participants will be monitored for possible adverse events or complications for at least 30 minutes after the procedure. Clinical outcomes will be assessed at baseline, 3 weeks, 6 weeks, and 12 weeks.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Esra Ülgen Kıratlıoğlu, MD
- Номер телефона: +905079614194
- Электронная почта: esraulgen@gmail.com
Места учебы
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Ankara, Турция (Туркие)
- Рекрутинг
- Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
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Контакт:
- Esra Ülgen Kıratlıoğlu
- Номер телефона: +905079614194
- Электронная почта: esraulgen@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Diagnosis of chronic plantar fasciitis based on medical history and physical examination
- Heel pain resistant to conservative treatment for at least 12 weeks
- Age between 18 and 70 years
- Willingness to participate in the study and provide written informed consent
Exclusion Criteria:
- Congenital or acquired disease that may impair or prevent foot function, such as rheumatoid arthritis, hemiplegia, congenital foot deformity, traumatic foot or leg amputation, or fracture sequelae
- Local infection or skin disease at the treatment site
- Bleeding disorder or use of anticoagulant medication within the last week
- Disease causing mental dysfunction, such as uncontrolled Parkinson disease or Alzheimer disease
- Previous surgery for plantar fasciitis
- Refusal to participate in the study or inability to provide informed consent
- Failure to attend follow-up visits after treatment
- Request to withdraw from the study
- Pregnancy or suspected pregnancy
- Presence of a cardiac pacemaker
- History of epilepsy
- Active or previous malignancy
- Rheumatologic disease
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Ultrasound-Guided Pulsed Radiofrequency Treatment
Participants in this group will receive ultrasound-guided pulsed radiofrequency treatment at baseline.
Clinical follow-up assessments will be performed at 3 weeks, 6 weeks, and 12 weeks.
All participants will also receive a home-based plantar fascia stretching exercise program.
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Ultrasound-guided pulsed radiofrequency treatment will be applied for chronic plantar fasciitis.
Participants will be monitored for at least 30 minutes after the procedure for possible adverse events or complications.
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Активный компаратор: Ultrasound-Guided 5% Dextrose Injection
Ultrasound-guided pulsed radiofrequency treatment will be applied for chronic plantar fasciitis.
Participants will be monitored for at least 30 minutes after the procedure for possible adverse events or complications.
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Ultrasound-guided 5% dextrose injection will be applied around the medial calcaneal insertion of the plantar fascia using the peppering technique, with 0.1-0.2
mL administered at each entry point.
The treatment will consist of three sessions performed at 3-week intervals.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Heel Pain Intensity Assessed by Numeric Rating Scale
Временное ограничение: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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Heel pain intensity will be assessed using the Numeric Rating Scale.
Resting pain, pain during plantar fascia stretching, and pain with pressure will be evaluated on an 11-point scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Activity-Related Pain Assessed by the Roles and Maudsley Score
Временное ограничение: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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Activity-related heel pain and functional status will be assessed using the Roles and Maudsley Score.
The score ranges from 1 to 4, with lower scores indicating better clinical status and higher scores indicating worse pain and functional limitation.
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Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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Change in Foot Function Assessed by the Foot Function Index
Временное ограничение: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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Foot-related pain, disability, and activity limitation will be assessed using the Foot Function Index.
The scale includes pain, disability, and activity limitation subscales.
Scores are converted to a 0-100 scale, with higher scores indicating greater pain, disability, and activity limitation.
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Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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Change in Ankle-Hindfoot Function Assessed by the American Orthopaedic Foot and Ankle Society Score
Временное ограничение: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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Ankle-hindfoot function will be assessed using the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score.
The score evaluates pain, function, and alignment.
The total score ranges from 0 to 100, with higher scores indicating better ankle-hindfoot function.
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Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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Change in Health-Related Quality of Life Assessed by the Nottingham Health Profile
Временное ограничение: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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Health-related quality of life will be assessed using the Nottingham Health Profile.
The questionnaire includes six domains: energy level, pain, emotional reactions, sleep, social isolation, and physical activity.
The total score ranges from 0 to 600, with higher scores indicating worse perceived health status.
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Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- E2-26-14591
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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