Progressive Achilles Loading Via Clinician E-support
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorRuth Chimenti
About this trial
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
This trial does not accept healthy volunteersQualifiers
Pain localized to the Achilles tendon (insertion or midportion)
AT pain greater than or equal to 3/10 with tendon-loading exercise
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Other interventionAll participants will be instructed in a progressive Achilles tendon loading exercise program.
Education
Other interventionAll 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Single-visit, Physical Therapist Initiated and Self-Pace RehabilitationExperimental treatment 2 interventions
Group B: Multi-visit, Physical Therapist Guided RehabilitationActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Tendon 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 weeks2
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ruth Chimenti
Lead sponsor
University of Iowa
Sponsor institution
C.R.Darnall Army Medical Center
Collaborator
United States Department of Defense
Collaborator
Source ClinicalTrials.gov