Progressive Achilles-loading program with remote clinician support
Progressive Achilles Loading Via Clinician E-support (PACE)
NA · University of Iowa · NCT06736795
This trial tests whether a single telehealth visit plus self-guided exercise and education works as well as multiple telehealth physical therapy visits for adults with Achilles tendon pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Iowa (other) |
| Locations | 2 sites (Iowa City, Iowa and 1 other locations) |
| Trial ID | NCT06736795 on ClinicalTrials.gov |
What this trial studies
This single-blind, two-arm randomized non-inferiority trial compares a one-time PT-initiated telehealth visit plus asynchronous exercise and education modules to a standard PT-guided program of six telehealth visits. The study will enroll 160 adults with Achilles tendinopathy across two sites (University of Iowa and Carl R. Darnall Army Medical Center). Primary outcomes are changes in pain and disability, with a secondary aim to identify early patient-reported changes within two weeks that predict four-week improvements. Interventions are focused on progressive tendon-loading exercises and patient education delivered remotely.
Who should consider this trial
Good fit: Adults aged 18–60 with localized Achilles tendon pain of at least 3/10 during tendon-loading exercise who have not had recent PT, injections, or contraindicated treatments and who can participate in telehealth are ideal candidates.
Not a fit: People with partial tendon tears, a history of Achilles rupture, recent injections or shockwave therapy, recent PT for Achilles, certain differential diagnoses (e.g., bursitis, sural nerve neuropathy, plantaris involvement), very high BMI, or ages outside 18–60 are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could expand access to rehabilitation, shorten time to recovery, and help more people—including deployed military personnel—return to full duty faster.
How similar studies have performed: Exercise and education are established treatments for Achilles tendinopathy, but randomized trials directly comparing single-visit, PT-initiated remote programs to multi-visit PT care are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pain localized to the Achilles tendon (insertion or midportion) * AT pain greater than or equal to 3/10 with tendon-loading exercise Exclusion Criteria: * 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
Where this trial is running
Iowa City, Iowa and 1 other locations
- University of Iowa Health Care - Gait Analysis Laboratory — Iowa City, Iowa, United States (RECRUITING)
- Carl R. Darnall Army Medical Center (CRDAMC) — Fort Cavazos, Texas, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Ruth L Chimenti, PT, PhD — University of Iowa
- Study coordinator: Jessica Danielson, DDS
- Email: chimenti-lab@uiowa.edu
- Phone: 319-356-1722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Achilles Tendon Pain, Achilles Tendinopathy, ultrasound imaging, tendon health, pain, exercise, physical therapy, education