Clinical trial NCT06374654: RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy
Official title: Randomized Controlled Trial of Home-based Versus Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Achilles Tendinopathy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Victorian Institute of Sports Assessment self-administered Achilles questionnaire (VISA-A)
timeFrame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
Secondary outcomes:
measure: PROMIS Pain Interference (4a)
timeFrame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
measure: PROMIS Pain Intensity (3a)
timeFrame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
measure: PROMIS Depression (4a)
timeFrame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
measure: Patient Acceptable Symptom State Questionnaire
timeFrame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Christopher P Chiodo, MD
role: PRINCIPAL_INVESTIGATOR
References: