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Enrolling by Invitation

NCT Number: NCT06374654

RCT of Home-based vs 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.

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Key information

Conditions

Achilles Tendinopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02130, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based Exercise Protocol

Other

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.

Formal Physical Therapy

Other

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.

Primary outcomes

  1. 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

  1. PROMIS Pain Interference (4a)

    Time frame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment

  2. PROMIS Pain Intensity (3a)

    Time frame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment

  3. PROMIS Depression (4a)

    Time frame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment

  4. Patient Acceptable Symptom State Questionnaire

    Time frame: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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