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Behavioural Intervention

Progressive Achilles Loading Via Clinician E-support (PACE Trial)

N/A
Waitlist Available
Led By Ruth L Chimenti, PT, PhD
Research Sponsored by Ruth Chimenti
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Pain localized to the Achilles tendon (insertion or midportion)
* AT pain greater than or equal to 3/10 with tendon-loading exercise
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to 4 weeks
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for individuals with Achilles tendon pain, including tendinitis and tendinopathy. It's aimed at helping military personnel who may face delays in accessing healthcare. Participants should be seeking an effective rehabilitation program that can be delivered even in busy or remote settings.
What is being tested?
The study is testing a rehabilitation program consisting of exercise and education to treat Achilles tendon pain. It's a randomized controlled trial, meaning participants are randomly assigned to different treatment groups to compare outcomes.
What are the potential side effects?
Since the interventions involve exercise and education, side effects might include muscle soreness or strain from physical activity. However, these are typically mild and temporary as part of any new exercise regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disability
Pain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Single-visit, Physical Therapist Initiated and Self-Pace RehabilitationExperimental Treatment2 Interventions
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.
Group II: Multi-visit, Physical Therapist Guided RehabilitationActive Control2 Interventions
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.

Find a Location

Who is running the clinical trial?

Ruth ChimentiLead Sponsor
2 Previous Clinical Trials
112 Total Patients Enrolled
United States Department of DefenseFED
916 Previous Clinical Trials
334,565 Total Patients Enrolled
C.R.Darnall Army Medical CenterFED
16 Previous Clinical Trials
5,686 Total Patients Enrolled
Ruth L Chimenti, PT, PhDPrincipal InvestigatorUniversity of Iowa
Matthew Frazier, PT, DPT, MS, ATCStudy DirectorCarl R. Darnall Army Medical Center (CRDAMC), Fort Cavazos
~107 spots leftby Jun 2028