Achilles TendinopathyNCT06374654
RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy
A study testing Home-based Exercise Protocol and Formal Physical Therapy in people with Achilles Tendinopathy, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Home-based Exercise Protocol and Formal Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 3 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Patients who have had prior foot or ankle surgery
- Individuals that do not speak English
- Bilateral disease
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02130
About this study
Official title: 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.
- Conditions
- Achilles Tendinopathy
- Being tested
- Home-based Exercise Protocol, Formal Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Exercise ProtocolOther
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 TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based Protocol | Experimental | Not described Receives: Other: Home-based Exercise Protocol |
| Formal Physical Therapy Protocol | Experimental | Not described Receives: Other: Formal Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
Secondary outcomes (4)
PROMIS Pain Interference (4a)
Measured: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
PROMIS Pain Intensity (3a)
Measured: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
PROMIS Depression (4a)
Measured: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
Patient Acceptable Symptom State Questionnaire
Measured: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Jul 2025
- Primary completion2 Jul 2027 (estimated)
- Study completion3 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Chiodo, Brigham and Women's Hospital
- Investigators
- Christopher P Chiodo, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374654
- Sponsor's protocol ID
- 2023P003272
- Status last verified
- Nov 2025
- First submitted
- 16 Apr 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Home-based Versus Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT06374654
- Acronym / sponsor ID
- 2023P003272
- Conditions
- Achilles Tendinopathy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 2 Jul 2027 (estimated)
- Study completion
- 3 Jul 2027 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based Protocol | Experimental | Other: Home-based Exercise Protocol |
| Formal Physical Therapy Protocol | Experimental | Other: Formal Physical Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based Exercise ProtocolThe 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 | Home-based Protocol |
| Formal Physical TherapyPatients 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. | Other | Formal Physical Therapy Protocol |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher P Chiodo, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Exercise Protocol and Formal Physical Therapy in people with Achilles Tendinopathy, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.