Recruiting

Achilles Tendon Pain

Sponsor:

Ruth Chimenti

Code:

NCT06736795

Conditions

Achilles Tendon Pain

Achilles Tendinopathy

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Exercise

Education

Study Details

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.

Conditions

Achilles Tendon Pain

Achilles Tendinopathy

Study ID

NCT06736795

Start date

Aug 20, 2025

Status verified date

Oct, 2025

Completion date

Jul, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single-visit, Physical Therapist Initiated and Self-Pace Rehabilitation

Participants 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.

active comparator: Multi-visit, Physical Therapist Guided Rehabilitation

Participants 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

Exercise

All participants will be instructed in a progressive Achilles tendon loading exercise program.

Education

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.

Primary outcome measure

  • Tendon Pain [ Time Frame: From enrollment to 4 weeks ]
  • Disability [ Time Frame: From enrollment through 4 weeks ]

Central Contacts and Locations

Central contacts

Jessica Danielson, DDS

319-356-1722chimenti-lab@uiowa.edu

Jessica F Danielson, DDS

319-356-1722Jessica-danielson@uiowa.edu

Locations

University of Iowa Health Care - Gait Analysis Laboratory

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Jessica Danielson, DDS

319-335-9791Chimenti-lab@uiowa.edu

Jessica F Danielson, DDS

319-356-1722jessica-danielson@uiowa.edu

Principal Investigator:

Ruth L Chimenti, PT, PhD

More Information

Sponsor

Ruth Chimenti

Last update posted

Oct 7, 2025

Last verified

Oct, 2025

Keywords

  • ultrasound imaging
  • tendon health
  • pain
  • exercise
  • physical therapy
  • education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ruth Chimenti on 2025-10-07.