Comparison of the Effectiveness of Dextrose Prolotherapy and Extracorporeal Shock Wave Therapy (ESWT) in Plantar Fasciitis

Обзор

Plantar fasciitis is a degeneration of the plantar aponeurosis and is the most common cause of heel pain (11-15%). Although seen in both sexes, plantar fasciitis is more common in women, usually unilateral and bilateral in 30% of cases . The most widely accepted view regarding the formation of plantar fasciitis is that it is a degenerative process caused by myxoid degeneration, microtears, collagen necrosis, and angiofibroblastic hyperplasia, resulting from repetitive microtrauma to the plantar fascia, particularly at the calcaneal insertion site. It is not inflammatory . The purpose of this study was to compare the effectiveness of prolotherapy, a regenerative treatment, and ESWT in the treatment of plantar fasciitis.

Подробное описание

Plantar fasciitis is known as the most common cause of heel pain in adults. While its incidence increases between the ages of 40 and 60, it is more common in runners, those who work in positions requiring prolonged standing, overweight individuals, and those with certain biomechanical foot problems. Diagnosis of plantar fasciitis can be easily made through history and physical examination. Conservative methods are the first line of treatment. Local injections and ESWT are used in patients who fail to improve despite conservative treatment. ESWT and Prolotherapy are treatment methods that induce regeneration by creating a controlled inflammation. This prospective study aims to compare the effectiveness of ESWT and Prolotherapy, which have similar mechanisms of action, in the treatment of plantar fasciitis and to identify the more effective method.

Вмешательства

• Процедура Dextrose Prolotherapy
  Participants in this group will receive dextrose prolotherapy twice, at two-week intervals. A 5 mL syringe containing 2.5 mL of 30% dextrose, 2 mL isotonic saline, and 0.5 mL 2% lidocaine (final 15% dextrose solution) will be injected into seven points around the plantar fascia origin under aseptic conditions.
• Устройство Extracorporeal Shock Wave Therapy (ESWT)
  Participants in this group will receive extracorporeal shock wave therapy (ESWT) twice per week for a total of four sessions. The treatment will be applied to the plantar fascia insertion area using a standard clinical shock wave therapy device. Energy level, frequency, and pulse count will be set according to manufacturer recommendations and standard clinical protocols.

Первичные конечные точки

• Change in Heel Pain Intensity (VAS Score) [Срок оценки: Baseline, 6 weeks, 12 weeks]

Вторичные конечные точки (2)

• Change in Foot Function Index (FFI) Total Score [Срок оценки: Baseline, 6 weeks, 12 weeks]
• Change in Roles and Maudsley Score [Срок оценки: Baseline, 6 weeks, 12 weeks]

Критерии участия

Критерии включения

• Diagnosis of plantar fasciitis

Ages 18 to 75 years

Both male and female participants

Heel pain localized to the medial calcaneal tubercle for more than 3 months

Morning first-step pain and pain increasing with daily loading

Willingness to participate and provide written informed consent

Patients presenting to Kanuni Sultan Süleyman Training and Research Hospital

Критерии исключения

Cardiac pacemaker

Type 1 or Type 2 diabetes mellitus

History of inflammatory rheumatic disease

Bleeding disorders

Use of anticoagulant medications other than aspirin

Allergy to dextrose

Previous foot or ankle surgery

Peripheral neuropathy

S1 radiculopathy in the same extremity

Local corticosteroid injection to the plantar fascia within the last 3 months

ESWT applied to the plantar fascia within the last 3 months

Physical therapy applied to the foot/ankle in the last 3 months

Cognitive dysfunction

Active infection at the planned injection site

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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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07233395 · KanuniSSTRH-PF-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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