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

NCT06374654 | Enrolling By Invitation

• 1 other identifier: 2023P003272
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

• Victorian Institute of Sports Assessment self-administered Achilles questionnaire (VISA-A)

  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 Outcomes (4)

• PROMIS Pain Interference (4a)

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

• PROMIS Pain Intensity (3a)

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

• PROMIS Depression (4a)

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

• Patient Acceptable Symptom State Questionnaire

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

Study Arms (2)

Home-based Protocol

EXPERIMENTAL

Other: Home-based Exercise Protocol

Formal Physical Therapy Protocol

EXPERIMENTAL

Other: Formal Physical Therapy

Interventions

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.

Home-based Protocol

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.

Formal Physical Therapy Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02130, United States

Location

Study Officials

• Christopher P Chiodo, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 18, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 2, 2027
• Study Completion (Estimated): July 3, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)