Progressive Achilles Loading Via Clinician E-support

Phase

N/A

Condition

Tendon Injuries

Pain

Sprains

Treatment

Exercise

Education

Clinical Study ID

NCT06736795

202405285

HT94252410536

Ages 18-60
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 ofAchilles 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 anyinjection 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., rheumatoidarthritis, ankylosing spondylitis), endocrine disorder with complications (e.g.,uncontrolled Type I or II diabetes, diabetic peripheral neuropathy), connectivetissue 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 witha webcam or smart phone or completing quizzes and surveys

Study Design

Exercise

August 20, 2025

July 31, 2028

Study Description

The objectives of this non-inferiority trial are to identify a rehabilitation program focused on education and exercise for AT that expands access to care for military personnel and to identify factors that predict responses to rehabilitation. The following aims will test our central hypothesis that a single-visit, PT-initiated rehabilitation program will be as effective in improving pain and reducing disability as a multi-visit, PT-guided rehabilitation program for AT and that within two weeks of initiating exercise treatment, early changes in patient-reported outcomes can identify responders.

Specific Aim 1. Determine the efficacy of a single-visit, PT-initiated rehabilitation program vs. a multi-visit, PT-guided rehabilitation program for AT.

Specific Aim 2. Identify early prognostic factors for individuals who experience the greatest improvement in pain and disability by four weeks.

Study Design. A single-blind, two-arm, parallel phase 2 randomized controlled trial is the study approach. Individuals with AT will be randomized to one of two rehabilitation programs: 1) self-guided intervention initiated with a single visit with a physical therapist (PT) via telehealth followed by modules that the participant can complete asynchronously, or 2) PT-guided intervention (standard of care) with six one-on-one telehealth visits. Study will enroll 160 individuals with AT across two sites (University of Iowa Hospitals & Clinics; Carl R. Darnall Army Medical Center, Fort Cavazos) and obtain baseline variables and immediate response at 2-weeks to characterize the sample. Outcomes will be assessed at 4 weeks (primary endpoint), 8 weeks, 26 weeks, and 1 year.

Connect with a study center

University of Iowa Health Care - Gait Analysis Laboratory
Iowa City, Iowa 52242
United States
Site Not Available
University of Iowa Health Care - Gait Analysis Laboratory
Iowa City 4862034, Iowa 4862182 52242
United States
Active - Recruiting
Carl R. Darnall Army Medical Center (CRDAMC)
Fort Cavazos, Texas 76544
United States
Site Not Available
Carl R. Darnall Army Medical Center (CRDAMC)
Fort Cavazos 7261291, Texas 4736286 76544
United States
Site Not Available

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