Shockwave Therapy for Plantar Fasciitis RCT
Ключові слова
Анотація
Опис
Plantar fasciitis is a common foot problem that affects 3.8 per 1,000 persons in the United States. It is characterized by inflammation of the plantar fascia, a fibrous tissue which connects the calcaneus to the metatarsal heads, and is often seen in individuals who are overweight and/or participate frequently in weight-bearing endurance activities such as running. Pain is typically at its highest during the first steps in the morning, although it can also occur with prolonged weightbearing. Plantar fasciitis can be treated via conservative or surgical measures, although surgery is considered as the last resort. In recent years, extracorporeal shockwave therapy has emerged as an alternative conservative method for treating plantar fasciitis. There are two types -- radial and focused shockwave therapy. Focused therapy creates deeper-penetrating, higher-energy shockwaves, whereas radial therapy produces more superficial shockwaves that can treat a wider area of pathology.
Randomized controlled trials have compared focused and radial shockwave therapy to placebo and other conservative measures in the treatment of chronic plantar fasciitis and overall demonstrated benefit. Only one study has directly compared radial and focused shockwave therapy in this population, although pain was not an outcome of focus in the study. The current study aims to collect patient-reported outcomes on both pain and function following radial vs. focused shockwave therapy vs. control therapy.
Дати
Востаннє перевірено: | 06/30/2020 |
Перший поданий: | 03/10/2020 |
Орієнтовна реєстрація подана: | 03/31/2020 |
Опубліковано вперше: | 04/01/2020 |
Останнє оновлення надіслано: | 07/26/2020 |
Останнє оновлення опубліковано: | 07/27/2020 |
Фактична дата початку навчання: | 03/08/2020 |
Розрахункова дата первинного завершення: | 07/31/2021 |
Розрахункова дата завершення дослідження: | 09/30/2021 |
Стан або захворювання
Втручання / лікування
Procedure: Radial shockwave therapy
Procedure: Focused shockwave therapy
Device: Shockwave therapy device
Other: Home therapy
Фаза
Групи рук
Рука | Втручання / лікування |
---|---|
Active Comparator: Control Patients in the control group will be treated using the home therapy protocol only. | |
Active Comparator: Radial shockwave therapy Patients will receive 4 sessions of radial shockwave therapy. | Procedure: Radial shockwave therapy Target intensity will be within a range of 3.5-5.0 bar at maximum Hz, titrated up to patient tolerance within 100 pulses. Total of 3000 pulses. |
Active Comparator: Focused shockwave therapy Patients will receive 4 sessions of focused shockwave therapy. | Procedure: Focused shockwave therapy Target intensity will be within a range of 0.15-0.25 mJ/mm2 at maximum Hz, titrated up to patient tolerance within 100 pulses. Total of 3000 pulses. |
Критерії прийнятності
Вік, придатний для навчання | 18 Years До 18 Years |
Стать, яка підходить для вивчення | All |
Приймає здорових добровольців | Так |
Критерії | Inclusion Criteria: - Patients presenting with a clinical diagnosis of chronic plantar fasciitis (>3 months) that has been recalcitrant to other treatments - Minimum VAS pain of 40/100 (4/10; morning pain when taking first steps, pain after prolonged walking/standing) - English-speaking Exclusion Criteria: - Cortisone injection within the past 3 months - Platelet-rich plasma injection within the past 6 months - History of previous foot surgery - Bilateral heel pain - Coagulopathies or use of anti-coagulants - Local and systemic neurologic or vascular insufficiencies - Rheumatologic disorders - Systemic inflammatory disorders - Active or chronic infection in the area - Lower extremity bone disorders (e.g., Paget's disease, osteomyelitis) - Calcaneal fractures - Nerve entrapment - Ruptures in tendon - Non-English speaking |
Результат
Заходи первинного результату
1. Visual analog scale pain - morning [Up to 1 year]
2. Visual analog scale pain - after prolonged walking or standing [Up to 1 year]
Заходи вторинного результату
1. PROMIS Physical Function computer adaptive test score [Up to 1 year]
2. Foot and Ankle Outcome Score (FAOS) [Up to 1 year]
3. Treatment satisfaction [Up to 1 year]