Progressive Achilles Loading Via Clinician E-support (PACE)

Ruth Chimenti

Status: Not yet enrolling

Conditions: Achilles Tendon Pain; Achilles Tendinopathy

Treatments: Other: Exercise; Other: Education

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06736795

202405285

HT94252410536 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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 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 inflammatory conditions (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

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

Experimental group

Description:

Participants will complete 7 online modules, which will take 30 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.

Treatment:

Other: Education

Other: Exercise

Multi-visit, Physical Therapist Guided Rehabilitation

Active Comparator group

Description:

Participants will attend 7 telehealth sessions over 8 weeks, which will last 30 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.

Treatment:

Other: Education

Other: Exercise