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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
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.
University of Iowa Health Care - Gait Analysis Laboratory
Iowa City, Iowa, United States
RECRUITINGCarl R. Darnall Army Medical Center (CRDAMC)
Fort Cavazos, Texas, United States
NOT_YET_RECRUITINGTendon 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."
Time frame: 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.
Time frame: From enrollment through 4 weeks
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