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

Mass General Brigham

Status: Invitation-only

Conditions: Achilles Tendinopathy

Treatments: Other: Formal Physical Therapy; Other: Home-based Exercise Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06374654

2023P003272

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Home-based Protocol

Experimental group

Treatment:

Other: Home-based Exercise Protocol

Formal Physical Therapy Protocol

Experimental group

Treatment:

Other: Formal Physical Therapy