RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy

Официальное название

Randomized Controlled Trial of Home-based Versus Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy

Обзор

The goal of this prospective randomized controlled trial is to compare the effectiveness of a home-based exercise protocol to formal physical therapy in patients who have been diagnosed with Achilles tendinopathy. The null hypothesis is that there will be no difference in the treatment outcomes between patients with Achilles tendinopathy who participate in a home-based program versus patients with Achilles tendinopathy who undergo formal physical therapy. Participants will be randomized to a 12-week home-based or formal physical therapy protocol and asked to complete brief outcomes surveys at their initial visit, and at 6 weeks, 12 weeks, 6 months, and 1 year after their initial visit.

Вмешательства

• Другое Home-based Exercise Protocol
  The home-based eccentric exercise protocol is a do-as-tolerated variation on the protocol described by Alfredson et al. in 1998. The protocol includes doing a series of heel raises, twice daily. No equipment is necessary. Patients will be given handouts and video links that depict and describe the exercises and their prescribed frequency.
• Другое Formal Physical Therapy
  Patients will be given a prescription for physical therapy consisting of 1-2 sessions per week for 6 weeks, with a renewal for another 6 weeks to be executed at the physical therapists' discretion. If an in-person visit is necessary for the renewal, or is requested by the physical therapist, the patient will be seen again in the office. Each patient will be given a release form to provide to his or her physical therapist. The release form will request a written record of all the treatment method

Первичные конечные точки

• Victorian Institute of Sports Assessment self-administered Achilles questionnaire (VISA-A) [Срок оценки: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment]

Вторичные конечные точки (4)

• PROMIS Pain Interference (4a) [Срок оценки: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment]
• PROMIS Pain Intensity (3a) [Срок оценки: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment]
• PROMIS Depression (4a) [Срок оценки: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment]
• Patient Acceptable Symptom State Questionnaire [Срок оценки: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment]

Критерии участия

Критерии включения

• Must be 18 years of age
• Must have a new diagnosis of Achilles tendinopathy that has presented with pain, thickening and tenderness at the mid substance of the Achilles tendon
• Symptoms present for at least 6 weeks

Критерии исключения

• Patients with insertional Achilles pain or tenderness or concomitant plantar foot pain
• Patients who have had prior treatment with home eccentric stretching or physical therapy
• Patients who have prior diagnosis and treatment for Achilles tendinopathy
• Patients with history of injection (corticosteroid or sclerosing agents) to the Achilles tendon
• Patients with inflammatory arthritis
• Recent fluoroquinolone antibiotics (these agents are known to alter Achilles tendon physiology)
• Patients who have had prior foot or ankle surgery
• Individuals that do not speak English
• Bilateral disease
• Pregnant women

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT06374654 · 2023P003272

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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