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

46 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized control trial with an elective cross over after three months to evaluate three different treatments in the management of non-insertional Achilles Tendinopathy. The treatment methods include physical therapy, shockwave therapy and photobiomodulation.

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.

What data supports the effectiveness of this treatment for Achilles tendinopathy?

Research shows that low-level laser therapy (LLLT) can be effective when combined with exercises for treating Achilles tendinopathy, as it may help reduce inflammation and pain. ^{1 2 3 4 5}

How is the treatment for Achilles tendinopathy unique?

This treatment combines photobiomodulation therapy (using light to promote healing), physical therapy, and shockwave therapy, offering a novel approach by integrating multiple therapies to enhance recovery. It is unique because it uses light therapy to potentially reduce pain and inflammation, alongside exercises and shockwaves, which may improve treatment outcomes compared to traditional methods. ^{2 3 4 6 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of low-level laser therapy in patients with lower extremity tendinopathy or plantar fasciitis: systematic review and meta-analysis of randomised controlled trials. [2022]

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

Clinical effectiveness of low-level laser therapy as an adjunct to eccentric exercise for the treatment of Achilles' tendinopathy: a randomized controlled trial. [2022]

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

Laser therapy in the treatment of achilles tendinopathy: a pilot study. [2022]

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

Photobiomodulation with low-level laser therapy for treating Achilles tendinopathy: a systematic review and meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A randomised, placebo controlled trial of low level laser therapy for activated Achilles tendinitis with microdialysis measurement of peritendinous prostaglandin E2 concentrations. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Photobiomodulation and eccentric exercise for Achilles tendinopathy: a randomized controlled trial. [2022]

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

The efficacy of low-level laser therapy for shoulder tendinopathy: a systematic review and meta-analysis of randomized controlled trials. [2022]