Achilles Tendon PainPACENCT06736795
Progressive Achilles Loading Via Clinician E-support
A study testing Exercise and Education in people with Achilles Tendon Pain and Achilles Tendinopathy, run by Ruth Chimenti at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Achilles Tendon Pain, Achilles Tendinopathy
- What is being tested?
- Exercise and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Aug 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pain localized to the Achilles tendon (insertion or midportion)
- AT pain greater than or equal to 3/10 with tendon-loading exercise
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Carl R. Darnall Army Medical Center (CRDAMC)
Fort Cavazos, Texas, 76544
Matthew Frazier, PT, DPT, MS, ATC, 254-286-7898, mathew.j.frazier.civ@health.mil
Jessica Danielson, DDS, 319-356-1722, chimenti-lab@uiowa.edu
- Recruiting
University of Iowa Health Care - Gait Analysis Laboratory
Iowa City, Iowa, 52242
Jessica Danielson, DDS, 319-335-9791, Chimenti-lab@uiowa.edu
Jessica F Danielson, DDS, 319-356-1722, jessica-danielson@uiowa.edu
About this study
Official title: Progressive Achilles Loading Via Clinician E-support (PACE)
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.
Read the detailed 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.
- Conditions
- Achilles Tendon Pain, Achilles Tendinopathy
- Being tested
- Exercise, Education
- Keywords
- ultrasound imaging, tendon health, pain, exercise, physical therapy, education
- Medical subject headings
- Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
All participants will be instructed in a progressive Achilles tendon loading exercise program.
EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-visit, Physical Therapist Initiated and Self-Pace Rehabilitation | Experimental | 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. Receives: Other: Exercise; Other: Education |
| Multi-visit, Physical Therapist Guided Rehabilitation | Active comparator | 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. Receives: Other: Exercise; Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
Measured: From enrollment through 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start20 Aug 2025
- Primary completionJun 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Achilles Tendon PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruth Chimenti
- Sponsor type
- University, hospital or other
- Collaborators
- C.R.Darnall Army Medical Center, United States Department of Defense
- Responsible party
- Sponsor-investigator, Ruth Chimenti, University of Iowa
- Investigators
- Ruth L Chimenti, PT, PhD, Principal investigator, University of IowaMatthew Frazier, PT, DPT, MS, ATC, Study director, Carl R. Darnall Army Medical Center (CRDAMC), Fort Cavazos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736795
- Sponsor's protocol ID
- 202405285
- Other IDs
- HT94252410536
- Acronym
- PACE
- Status last verified
- Oct 2025
- First submitted
- 12 Dec 2024
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Consistent with the Congressionally Directed Medical Research Programs Policy on Sharing Data and Research Resources, we will share the primary outcomes data and research resources, such as the rehabilitation handouts and videos. All data that is necessary to validate research outcomes and publications will be preserved and shared to allow other researchers the ability to reproduce the data and obtain additional findings that can advance the results. To ensure that other users can efficiently and accurately use the dataset, we will provide metadata and associated documentation. Information needed to understand the meaning of variable names and information about coding for missing data will be recorded in data dictionaries and readme files that will subsequently be shared alongside final datasets. Protocols, methods, statistical analyses, and any other relevant documentation
Publications
Wong MAKM, Frazier M, Jensen R, Fleagle T, Van Gorp B, Hall N, Ten Eyck P, Wendt L, Pacha M, Danielson J, Hall M, Wilken J, Chimenti RL. Progressive Achilles Loading via Clinician e-Support (PACE): Protocol for a Dual-Site Randomized Controlled Trial. JMIR Res Protoc. 2026 Apr 7;15:e90955. doi: 10.2196/90955.
PubMed 41945770
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Achilles Loading Via Clinician E-support (PACE)
- ClinicalTrials.gov ID
- NCT06736795
- Acronym / sponsor ID
- PACE / 202405285
- Conditions
- Achilles Tendon Pain, Achilles Tendinopathy
- Keywords
- ultrasound imaging, tendon health, pain, exercise, physical therapy, education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ruth ChimentiUniversity, hospital or other
- Collaborators
- C.R.Darnall Army Medical Center, United States Department of Defense
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-visit, Physical Therapist Initiated and Self-Pace Rehabilitation | Experimental | Other: Exercise, Other: EducationParticipants 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. |
| Multi-visit, Physical Therapist Guided Rehabilitation | Active comparator | Other: Exercise, Other: EducationParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pain localized to the Achilles tendon (insertion or midportion)
- AT pain greater than or equal to 3/10 with tendon-loading exercise
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAll participants will be instructed in a progressive Achilles tendon loading exercise program. | Other | Multi-visit, Physical Therapist Guided Rehabilitation, Single-visit, Physical Therapist Initiated and Self-Pace Rehabilitation |
| EducationAll 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. | Other | Multi-visit, Physical Therapist Guided Rehabilitation, Single-visit, Physical Therapist Initiated and Self-Pace Rehabilitation |
Primary outcome
Tendon Pain
Time frame: From enrollment to 4 weeks
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."
Disability
Time frame: From enrollment through 4 weeks
Victorian Institute of Sports Assessment-Achilles (VISA-A) with score range from 0 to 100. A lower score indicates greater symptom severity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Derived from this study: PubMed 41945770Wong MAKM, Frazier M, Jensen R, Fleagle T, Van Gorp B, Hall N, Ten Eyck P, Wendt L, Pacha M, Danielson J, Hall M, Wilken J, Chimenti RL. Progressive Achilles Loading via Clinician e-Support (PACE): Protocol for a Dual-Site Randomized Controlled Trial. JMIR Res Protoc. 2026 Apr 7;15:e90955. doi: 10.2196/90955.
- Individual participant dataSharing planned: Yes. Consistent with the Congressionally Directed Medical Research Programs Policy on Sharing Data and Research Resources, we will share the primary outcomes data and research resources, such as the rehabilitation handouts and videos. All data that is necessary to validate research outcomes and publications will be preserved and shared to allow other researchers the ability to reproduce the data and obtain additional findings that can advance the results. To ensure that other users can efficiently and accurately use the dataset, we will provide metadata and associated documentation. Information needed to understand the meaning of variable names and information about coding for missing data will be recorded in data dictionaries and readme files that will subsequently be shared alongside final datasets. Protocols, methods, statistical analyses, and any other relevant documentation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruth L Chimenti, PT, PhD principal investigator
University of Iowa
Matthew Frazier, PT, DPT, MS, ATC study director
Carl R. Darnall Army Medical Center (CRDAMC), Fort Cavazos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Education in people with Achilles Tendon Pain and Achilles Tendinopathy, run by Ruth Chimenti at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Danielson, DDS (319-356-1722, chimenti-lab@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tendon Pain (time frame: From enrollment to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06736795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.