Randomized Controlled Trial of Home-based Versus Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Victorian Institute of Sports Assessment self-administered Achilles questionnaire (VISA-A)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Home-based Protocol
Intervention: Home-based Exercise Protocol (Other)
Formal Physical Therapy Protocol
Intervention: Formal Physical Therapy (Other)
Outcomes
Primary Outcomes
Victorian Institute of Sports Assessment self-administered Achilles questionnaire (VISA-A)
Time Frame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
Achilles tendon-specific questionnaire that asks about patient pain, functional status, and activity level.
Secondary Outcomes
- PROMIS Depression (4a)(Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment)
- PROMIS Pain Interference (4a)(Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment)
- PROMIS Pain Intensity (3a)(Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment)
- Patient Acceptable Symptom State Questionnaire(Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment)
Investigators
Christopher Chiodo
MD
Brigham and Women's Hospital