RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home-based Exercise Protocol, Formal Physical Therapy.
- Who it may be relevant to
- Registry conditions: Achilles Tendinopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Trial of Home-based Versus Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy
Overview
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.
Interventions
- Other 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. - Other 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
Primary outcome measures
- 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]
Secondary outcome measures (4)
- PROMIS Pain Interference (4a) [Time frame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment]
- PROMIS Pain Intensity (3a) [Time frame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment]
- PROMIS Depression (4a) [Time frame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment]
- Patient Acceptable Symptom State Questionnaire [Time frame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Identifiers
NCT: NCT06374654 · 2023P003272