Combined Therapies for Achilles Tendinopathy

Overseen By Linh Pham

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Oral steroids, Fluoroquinolones

Disqualifiers: Rheumatological disease, Symptomatic arthritis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three treatments for non-insertional Achilles tendinopathy, a condition causing pain in the middle part of the Achilles tendon. Participants will undergo physical therapy, shockwave therapy, or photobiomodulation therapy (a type of light therapy) to determine which is most effective. The trial is open to individuals who have experienced Achilles pain for at least three months and previously ran at least 10 miles a week before the injury. As an unphased trial, it offers participants a unique opportunity to explore innovative treatments and contribute to advancing medical knowledge.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking oral steroids or fluoroquinolone antibiotics.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that photobiomodulation therapy, which uses low-level laser therapy, has mixed results. Some studies suggest it might help with pain and healing in tendon problems, but the evidence remains weak. It is considered safe, but further research is needed to confirm its benefits.

Shockwave therapy has a better safety record. Studies consistently demonstrate its effectiveness and safety for treating long-term Achilles tendon issues. It helps reduce pain and improve function without major side effects. Some patients might feel sore immediately after treatment, but this usually resolves quickly.

These therapies have varying levels of evidence supporting their use, but both are generally well-tolerated. Always consider discussing any treatment with a healthcare professional before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Achilles tendinopathy because they offer innovative approaches compared to traditional methods like rest, ice, compression, elevation (RICE), and standard physical therapy. Photobiomodulation therapy uses light to stimulate cellular repair, which can accelerate healing and reduce inflammation more effectively. Shockwave therapy delivers acoustic waves to improve blood flow and tissue regeneration, offering a potential boost in recovery speed and pain relief. Combining these with physical therapy might provide a comprehensive approach that enhances overall treatment outcomes, giving hope for faster and more effective healing.

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

This trial will evaluate different combinations of therapies for Achilles tendinopathy. Studies have shown that shockwave therapy, one of the treatments in this trial, effectively treats midportion Achilles tendinopathy. It reduces pain and improves movement, with several studies noting its safety and effectiveness for pain relief and enhanced mobility.

Photobiomodulation therapy, another treatment option in this trial, has shown mixed results. Some studies indicate it can aid movement and strength, but the evidence remains weak. While it might help, it is not as well-supported by research as shockwave therapy.

Physical therapy, also under study in this trial, is effective and commonly used for managing Achilles tendinopathy. It improves movement and reduces pain, often as part of a combined treatment plan. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people with non-insertional Achilles tendinopathy who primarily run, averaging at least 10 miles per week, and have a VISA-A score below 80. It's not for those with insertional tendinopathy, pregnant women, or individuals currently in physical therapy for over four weeks. Also excluded are those who've had shockwave therapy or injections recently, have rheumatological diseases, symptomatic foot arthritis, other running injuries besides Achilles tendinopathy, or are on certain medications.

Inclusion Criteria

I have been diagnosed with mid-portion Achilles tendinopathy.

Before getting injured, you used to run as your main physical activity and you would run an average of 10 miles or more each week.

VISA-A <80 at baseline to be eligible

Exclusion Criteria

I am currently pregnant.

I have Achilles tendon pain where it attaches to the heel.

I have had an Achilles tendon tear in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three treatment arms: physical therapy only, physical therapy and shockwave therapy, or physical therapy, shockwave therapy and photobiomodulation

3 months

Elective Cross-Over

Participants may choose to switch to a different treatment arm than they were initially randomized

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Photobiomodulation Therapy
• Physical Therapy
• Shockwave Therapy

Trial Overview The study compares the effectiveness of three treatments: physical therapy (exercises), shockwave therapy (sound waves to promote healing), and photobiomodulation (light therapy) in managing Achilles tendon pain away from the heel bone. Participants will be randomly assigned to one treatment but can switch after three months if they choose.

How Is the Trial Designed?

Group I: Shockwave Therapy and Physical Therapy Experimental Treatment 2 Interventions

Group II: Photobiomodulation, Shockwave Therapy and Physical Therapy Experimental Treatment 3 Interventions

Group III: Physical Therapy Only Active Control 1 Intervention

Photobiomodulation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Approved in European Union as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Approved in Canada as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6860369/

Immediate effect of photobiomodulation therapy on Achilles ... Conclusion: When treated with a laser-induced PBM treatment, healthy and pathologic Achilles tendons do not have immediate (within 4 hours) changes in tendon ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590109522000477

Photobiomodulation Associated With Conservative ... Results. Both groups demonstrated an increase in the Achilles Tendon Rupture Score and improvements in range of motion, plantar flexor strength, and pain. There ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32204620/

Photobiomodulation with low-level laser therapy for ... Conclusion: The certainty of evidence was low to very low, and the results are insufficient to support the routine use laser therapy for Achilles tendinopathy.

4. bmcsportsscimedrehabil.biomedcentral.com bmcsportsscimedrehabil.biomedcentral.com/articles/10.1186/s13102-021-00306-z

The effect of low-level red and near-infrared ... There is very-low-to-moderate quality evidence demonstrating that PBM has utility as a standalone and/or adjunctive therapy for tendinopathy disorders.

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/0269215520912820

Photobiomodulation with low-level laser therapy ... The purpose of this study was to determine the benefits and harms of low-level laser therapy for Achilles tendinopathy.

6. bmjopen.bmj.com bmjopen.bmj.com/content/12/9/e059479

Efficacy of low-level laser therapy in patients with lower ... LLLT significantly reduces pain and disability in lower extremity tendinopathy and plantar fasciitis in the short and medium term.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1572100025007653

Light Transmission and Thermal Impact of Different ... To compare light transmission and thermal effects of three photobiomodulation therapy devices on the in situ Achilles tendon of healthy adults.

8. liebertpub.com liebertpub.com/doi/10.1089/photob.2021.0192

Photobiomodulation for Tendinopathy: A Review of ... Data revealed that most of the studies (86%, 19/22) reported significant outcomes of laser Photobiomodulation in the healing of injured rat ...