Progressive Achilles Loading Via Clinician E-support
PACE
2 other identifiers
interventional
160
1 country
2
Brief Summary
This is a randomized controlled trial with individuals who have Achilles tendon pain. This study is designed to identify an effective rehabilitation program for Achilles tendon pain that expands access to care for military personnel and to predict treatment response. Limited or delayed access to healthcare can exacerbate the severity of pain and duration of disability due to AT. This is particularly relevant for individuals deployed to battlefield settings or are being seen in busy military treatment facilities. Therefore, it is crucial to identify efficient and effective treatment pathways that maximize healthcare access and facilitate a rapid and pain-free return to full duty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2024
CompletedFirst Posted
Study publicly available on registry
December 17, 2024
CompletedStudy Start
First participant enrolled
August 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
October 7, 2025
October 1, 2025
2.8 years
December 12, 2024
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Tendon Pain
Participants will report the intensity of movement-evoked pain during single limb heel raises using the Verbal Numeric Rating Scale (NRS, 0 to 10). Where "0" represents "no pain" and "10" indicates "worst pain imaginable."
From enrollment to 4 weeks
Disability
Victorian Institute of Sports Assessment-Achilles (VISA-A) with score range from 0 to 100. A lower score indicates greater symptom severity.
From enrollment through 4 weeks
Study Arms (2)
Single-visit, Physical Therapist Initiated and Self-Pace Rehabilitation
EXPERIMENTALParticipants will complete 6 online modules, which will take 10 to 20 minutes each. The modules can be completed at their own pace over 8 weeks and include: 1. Exercise participation: Participants will receive instruction on how to progress a home exercise program. Participants will also need to complete a home exercise log. 2. Education: Participants will be given homework to do at home in between online module sessions. Online quizzes will help review the educational material.
Multi-visit, Physical Therapist Guided Rehabilitation
ACTIVE COMPARATORParticipants will attend 6 to 7 telehealth sessions over 8 weeks, which will last 30 to 45 minutes each and include: 1. Exercise participation: Instruction from a physical therapist will be provided on how to complete a home exercise program between treatment sessions. Participants will also need to complete a home exercise log. 2. Education: Participants will be given homework and online quizzes to do at home in between treatment sessions. The physical therapist will review the educational material at each visit.
Interventions
All participants will be instructed in a progressive Achilles tendon loading exercise program.
All participants will receive education on Achilles tendinopathy terminology, common symptoms, diagnosis, expected recovery timeline, importance of physical activity, self-management strategies, multiple factors influencing pain, alternative and adjunct treatment options.
Eligibility Criteria
You may qualify if:
- Pain localized to the Achilles tendon (insertion or midportion)
- AT pain greater than or equal to 3/10 with tendon-loading exercise
You may not qualify if:
- Younger than 18 years of age or older than 60 years of age
- BMI \> 45 kg/m2
- Pain primarily due to a differential diagnosis, including paratendonitis, bursitis (retrocalcaneal or subcutaneous), posterior ankle impingement or os trigonum, irritation or neuropathy of the sural nerve, plantaris tendon involvement)
- Presence of a partial Achilles tendon tear or rupture on imaging or a history of Achilles tendon rupture that was verified by surgical or conservative management
- Attended physical therapy for AT in the past 3 months
- History of steroid injection to lower extremity tendons/fascia, ESWT or any injection to the Achilles tendon region in the past 3 months
- History of taking fluoroquinolones in the past 6 months
- History of surgery or invasive procedure for AT on side enrolling for treatment
- Diagnosed systemic conditions affecting the foot and ankle (e.g., rheumatoid arthritis, ankylosing spondylitis), endocrine disorder with complications (e.g., uncontrolled Type I or II diabetes, diabetic peripheral neuropathy), connective tissue disorder (e.g., Marfan's syndrome, Ehlers Danlos), or pregnancy
- At high risk for falls (four step square test \>15 seconds)
- Refusal of randomization or unable or uninterested in completing virtual visits with a webcam or smart phone or completing quizzes and surveys
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruth Chimentilead
- C.R.Darnall Army Medical Centercollaborator
- United States Department of Defensecollaborator
Study Sites (2)
University of Iowa Health Care - Gait Analysis Laboratory
Iowa City, Iowa, 52242, United States
Carl R. Darnall Army Medical Center (CRDAMC)
Fort Cavazos, Texas, 76544, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruth L Chimenti, PT, PhD
University of Iowa
- STUDY DIRECTOR
Matthew Frazier, PT, DPT, MS, ATC
Carl R. Darnall Army Medical Center (CRDAMC), Fort Cavazos
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor, Physical Therapy and Rehabilitation Science
Study Record Dates
First Submitted
December 12, 2024
First Posted
December 17, 2024
Study Start
August 20, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
October 7, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- IPD will be available within 1 year of completing the study and remain available for at least 10 years
- Access Criteria
- A link to the data will be shared upon publication or within 1 year of completing the study, whichever occurs first. The primary outcome data and resources will be freely available to the public via Iowa Research Online repository. The repository is open access and maintained by the Libraries at the University of Iowa for the preservation and sharing of intellectual work of faculty, students, and staff.
Consistent with the Congressionally Directed Medical Research Programs Policy on Sharing Data and Research Resources, we will share the primary outcomes data and research resources, such as the rehabilitation handouts and videos. All data that is necessary to validate research outcomes and publications will be preserved and shared to allow other researchers the ability to reproduce the data and obtain additional findings that can advance the results. To ensure that other users can efficiently and accurately use the dataset, we will provide metadata and associated documentation. Information needed to understand the meaning of variable names and information about coding for missing data will be recorded in data dictionaries and readme files that will subsequently be shared alongside final datasets. Protocols, methods, statistical analyses, and any other relevant documentation