Progressive Achilles Loading for Achilles Tendon Pain

(PACE Trial)

Recruiting at 1 trial location

Overseen By Jessica Danielson, DDS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ruth Chimenti

Must not be taking: Fluoroquinolones, Steroid injections

Disqualifiers: Age, BMI, Systemic inflammatory conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 8 weeks

160 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a history of taking fluoroquinolones in the past 6 months, you may not be eligible to participate.

What data supports the effectiveness of the treatment Progressive Achilles Loading for Achilles Tendon Pain?

Research shows that early loading and mobilisation can improve outcomes for Achilles tendon injuries, and heavy eccentric calf training has been effective in reducing pain and improving function in Achilles tendinopathy. These findings suggest that progressive loading may also be beneficial for Achilles tendon pain. ^{1 2 3 4 5}

Is Progressive Achilles Loading safe for humans?

There is no specific safety data on Progressive Achilles Loading, but general research on Achilles tendon treatments suggests that factors like obesity and physical activity levels can affect tendon health. It's important to consider these factors when evaluating safety. ^{6 7 8 9 10}

How does the Progressive Achilles Loading treatment differ from other treatments for Achilles tendon pain?

Progressive Achilles Loading is unique because it focuses on gradually increasing the load on the Achilles tendon, which may help in adapting the tendon to stress and reducing pain. Unlike traditional eccentric loading exercises, this approach may involve a more tailored progression of exercises to address individual pain locations and responses. ^{4 11 12 13 14}

What is the purpose of 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.

Research Team

Ruth L Chimenti, PT, PhD

Principal Investigator

University of Iowa

Matthew Frazier, PT, DPT, MS, ATC

Principal Investigator

Carl R. Darnall Army Medical Center (CRDAMC), Fort Cavazos

Eligibility Criteria

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.

Inclusion Criteria

My pain is 3 or more on a scale of 10 when I exercise the affected tendon.

I have pain in my Achilles tendon.

Exclusion Criteria

BMI > 45 kg/m2

I have taken fluoroquinolone antibiotics in the last 6 months.

I am either under 18 or over 60 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a single-visit, PT-initiated rehabilitation program or a multi-visit, PT-guided rehabilitation program for Achilles tendon pain

8 weeks

7 telehealth sessions for multi-visit group; self-paced modules for single-visit group

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Assessments at 4 weeks, 8 weeks, 26 weeks, and 1 year

Treatment Details

Interventions

• Progressive Achilles Loading

Trial Overview 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.

Participant Groups

Group I: Single-visit, Physical Therapist Initiated and Self-Pace Rehabilitation Experimental Treatment 2 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 Rehabilitation Active Control 2 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.

Who Is Running the Clinical Trial?

Ruth Chimenti

Lead Sponsor

Trials

4

Recruited

390+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

C.R.Darnall Army Medical Center

Collaborator

Trials

17

Recruited

5,800+

Findings from Research

Eccentric overload training shows promise in reducing pain for patients with chronic Achilles tendinopathy, based on a systematic review of nine clinical trials.

However, due to significant methodological shortcomings in most studies, the exact effectiveness of this training method remains unclear, highlighting the need for larger, well-designed trials to confirm its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eccentric overload training in patients with chronic Achilles tendinopathy: a systematic review. Kingma, JJ., de Knikker, R., Wittink, HM., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Immediate full-weight-bearing mobilisation for repaired Achilles tendon ruptures: a pilot study. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of heavy eccentric calf training for treating mid-portion Achilles tendinopathy: a systematic review and meta-analysis. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

The EdUReP approach plus manual therapy for the management of insertional Achilles tendinopathy. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Eccentric overload training in patients with chronic Achilles tendinopathy: a systematic review. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Evidence-Based High-Loading Tendon Exercise for 12 Weeks Leads to Increased Tendon Stiffness and Cross-Sectional Area in Achilles Tendinopathy: A Controlled Clinical Trial. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Risk factors for complications after primary repair of Achilles tendon ruptures. [2022]

7. France pubmed.ncbi.nlm.nih.gov

Health-related quality of life in patients with Achilles tendinopathy: Comparison to the general population of the United Kingdom. [2022]

8. England pubmed.ncbi.nlm.nih.gov

ICON PART-T 2019-International Scientific Tendinopathy Symposium Consensus: recommended standards for reporting participant characteristics in tendinopathy research (PART-T). [2020]

9. Italy pubmed.ncbi.nlm.nih.gov

Achilles tendinopathy in amateur runners: role of adiposity (Tendinopathies and obesity). [2021]

10. United States pubmed.ncbi.nlm.nih.gov

THE MINIMUM CLINICALLY IMPORTANT DIFFERENCE ON THE VISA-A AND LEFS FOR PATIENTS WITH INSERTIONAL ACHILLES TENDINOPATHY. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Where is your pain? Achilles tendinopathy pain location on loading is different to palpation, imaging and recall location. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Eccentric loading for Achilles tendinopathy--strengthening or stretching? [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

Prediction of running-induced Achilles tendinopathy with pain sensitivity - a 1-year prospective study. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

No Difference in Clinical Effects When Comparing Alfredson Eccentric and Silbernagel Combined Concentric-Eccentric Loading in Achilles Tendinopathy: A Randomized Controlled Trial. [2022]