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

November 19, 2025 updated by: Christopher Chiodo, Brigham and Women's Hospital

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

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home-based Protocol
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.
Experimental: Formal Physical Therapy Protocol
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 methods used by the physical therapist. Physical therapists who participate in the care of patients in this study will treat each patient using any and all methods that their professional experience deems clinically necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
PROMIS Pain Interference (4a)
Time Frame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
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
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
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
Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Christopher P Chiodo, MD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

July 2, 2027

Study Completion (Estimated)

July 3, 2027

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P003272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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