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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best rehab program for individuals with Achilles tendon pain, focusing on military personnel who may have limited access to care. It compares two approaches: one where participants engage in exercises and learn through online modules at their own pace, and another involving regular telehealth sessions with a physical therapist. The first approach, Progressive Achilles Loading, features a structured exercise program to gradually increase the load on the Achilles tendon. It targets individuals with ongoing Achilles tendon pain, especially during activities like walking or running that stress the tendon. This study may suit those who haven't recently received physical therapy or specific treatments for their Achilles pain. As an unphased trial, it offers participants the chance to explore innovative rehabilitation strategies that could enhance their quality of life.

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 prior data suggests that this rehabilitation program is safe for individuals with Achilles tendon pain?

Research has shown that gradually increasing the load on the Achilles tendon is generally safe and well-tolerated. In one study, participants reported a significant drop in tendon pain, with levels decreasing from 5.5 to 2.5 on a scale of 0 to 10, indicating effective discomfort reduction. Another study found that starting with isometric exercises (holding a position without moving) is safe for the tendon and helps manage pain. Although reinjury can occur, especially with shorter recovery times, programs that gradually increase in intensity over at least 12 weeks tend to yield better results. Overall, these findings suggest that the treatment is safe and can effectively reduce pain when followed correctly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two innovative rehabilitation techniques for managing Achilles tendon pain, offering flexibility and personalized care. The first method allows participants to self-pace through online modules, providing them the freedom to fit rehabilitation into their own schedules while still receiving structured guidance. The second method involves multi-visit telehealth sessions with direct physical therapist guidance, offering a more interactive and personalized approach. Both methods emphasize a combination of exercise and education, potentially providing a more holistic and patient-friendly alternative to traditional in-person physical therapy sessions.

What evidence suggests that this trial's treatments could be effective for Achilles tendon pain?

This trial will compare two approaches for managing Achilles tendon pain through progressive loading exercises. Research has shown that gradually increasing exercises for the Achilles tendon can help manage pain. One study found that a 4-step exercise program that slowly increased activity levels improved symptoms in people with Achilles tendon pain. Another report found that 67% of patients were satisfied with this method. These results suggest that gradually adding more activity to the Achilles tendon can reduce pain and improve mobility. This approach can help patients return to their normal activities with less discomfort. Participants in this trial will either follow a single-visit, self-paced rehabilitation program or a multi-visit, physical therapist-guided rehabilitation program to evaluate the effectiveness of these methods. ^{2 6 7 8 9}

Who Is on the 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

Are You a Good Fit for This Trial?

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

I have pain in my Achilles tendon.

My pain is 3 or more on a scale of 10 when I exercise the affected 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

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.

Group II: Multi-visit, Physical Therapist Guided Rehabilitation Active Control 2 Interventions

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.

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9768072/

Evidence-Based High-Loading Tendon Exercise for 12 ... In Achilles tendinopathy, 12 weeks of heavy load resistance training did not result in superior effects in VISA-A score, pain, tendon thickness ...

2. bjsm.bmj.com bjsm.bmj.com/content/59/9/640

Effectiveness of reducing tendon compression in ... In sport-active patients with insertional Achilles tendinopathy, LTCR was more effective than HTCR in improving tendon pain and function at 12 and 24 weeks.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06736795

Progressive Achilles Loading Via Clinician E-support This study is designed to identify an effective rehabilitation program for Achilles tendon pain that expands access to care for military personnel and to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5956523/

Current Concepts Review Update: Insertional Achilles ... In a single case series study, Jonsson and colleagues had 67% (18/27) of patients reporting excellent or good satisfaction with the treatment, and on average ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2022/6268590

An Isometric and Functionally Based 4‐Stage Progressive ... Conclusion. Following the 4-stage rehabilitation program for AT based on isometric training and progressive loading, we observed improvement in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11022783/

An Isometric and Functionally Based 4-Stage Progressive ... Tenderness on palpation of the tendon (0–10) was reduced from 5.5 to 2.5 (P < 0.001). Color Doppler ultrasound activity (0–4) was reduced by 50%, from an ...

7. jospt.org jospt.org/doi/10.2519/jospt.2015.5885

A Proposed Return-to-Sport Program for Patients With ... Reinjury rates of Achilles tendinopathy in soccer players range from 27% to 44%. Notably, reinjury was more common following short recovery ...

8. researchprotocols.org researchprotocols.org/2020/11/e19111

Effect of Pain Education and Exercise on ... The exercise intervention is based on evidence supporting the use of isometric exercise as a safe starting point for tendon loading and for pain ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1466853X23000020

Achilles tendon forces and pain during common ... Yet, outcomes are better when loading is progressive, in programs of sufficient length (≥12 weeks), and when a pain monitoring system is used (Karin ...