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

Achilles Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06374654
• Other study ID #: 2023P003272
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2026

Study information

• Verified date: April 2024
• Source: Brigham and Women's Hospital
• Contact: Christopher P Chiodo, MD
• Phone: 6179837363
• Email: cchiodo[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PROMIS Pain Interference (4a)		Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
Secondary	PROMIS Pain Intensity (3a)		Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
Secondary	PROMIS Depression (4a)		Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
Secondary	Patient Acceptable Symptom State Questionnaire		Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment