What is the mechanism of action of this treatment?

Sclerotherapy with 25% dextrose and 1% lidocaine for Achilles Tendinopathy involves injecting a hypertonic dextrose solution that acts as an irritant to promote an inflammatory response, thereby stimulating tendon healing. Lidocaine provides local anesthesia to reduce pain during the procedure. This dual approach is significant for patients as it not only manages pain but also targets the underlying tendon pathology to promote recovery. Similar treatments like prolotherapy also use dextrose to induce inflammation and facilitate tissue repair, highlighting the importance of these mechanisms in treating Achilles Tendinopathy.

What side effects are associated with this type of intervention?

The most common side effects of sclerotherapy for Achilles Tendinopathy using 25% dextrose and 1% lidocaine include localized pain, swelling, and inflammation at the injection site due to the irritant nature of dextrose. Lidocaine may cause temporary numbness, tingling, or allergic reactions. Broadly, such treatments may also carry risks of infection, tendon rupture, or delayed healing.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments using sclerotherapy with 25% dextrose and 1% lidocaine for Achilles Tendinopathy. Generally, treatments for Achilles Tendinopathy include physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), and corticosteroid injections. Sclerotherapy, which involves injecting an irritant solution to promote healing, is an investigational treatment and not yet widely approved by the FDA for this condition. Lidocaine is commonly used as a local anesthetic in various medical procedures, but its specific combination with dextrose for Achilles Tendinopathy remains under study.

What other types of research exist?

Promising novel alternatives for Achilles tendinopathy treatment include platelet-rich plasma (PRP) injections, which utilize the patient's own blood components to promote healing, and extracorporeal shockwave therapy (ESWT), which uses sound waves to stimulate tissue repair. Both treatments have shown positive outcomes in clinical trials and are considered effective for tendinopathy management.

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Sclerosing Agent

Sclerotherapy for Achilles Tendinopathy

Phase 2 & 3

Waitlist Available

Led By J Preston Wiley, MD, MPE

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults 18 years of age and older with a minimum of 3 months of clinically determinant history and symptoms (pain) consistent with unilateral Achilles tendinopathy (enthesitis or mid-portion) as diagnosed by a sport medicine physician

Be older than 18 years old

Must not have

Individuals younger than 18 years of age will be excluded from this trial due to the complicating factors of musculoskeletal immaturity and the lack of relevant research of Achilles tendinopathy and neovascular bundles in this population

Individuals that have received any type of injection in or around the Achilles tendon

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Summary

This study is evaluating whether a sclerotherapy treatment is effective for people with chronic Achilles tendinopathy.

Who is the study for?

This trial is for adults over 18 with chronic Achilles tendinopathy, who have tried a specific exercise program without success. It's not for professional athletes, those under 18, people with previous tendon ruptures or allergies to the treatment components, and anyone unable to do certain exercises.

What is being tested?

The study tests if injecting a mix of dextrose and lidocaine (sclerotherapy) can help treat chronic Achilles tendinopathy in patients who haven't improved after following an exercise regimen.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, allergic reactions to the substances used (dextrose or lidocaine), and possibly temporary worsening of tendon pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult with at least 3 months of Achilles tendon pain, diagnosed by a sports medicine doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am 18 years old or older.

Select...

I have received an injection in or near my Achilles tendon.

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I have had a previous Achilles tendon rupture.

Select...

I am allergic to certain sugar-based medical injections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: 25% Dextrose and 1% LidocaineActive Control2 Interventions

Group II: LidocainePlacebo Group1 Intervention

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Sclerotherapy with 25% dextrose and 1% lidocaine for Achilles Tendinopathy involves injecting a hypertonic dextrose solution that acts as an irritant to promote an inflammatory response, thereby stimulating tendon healing. Lidocaine provides local anesthesia to reduce pain during the procedure. This dual approach is significant for patients as it not only manages pain but also targets the underlying tendon pathology to promote recovery. Similar treatments like prolotherapy also use dextrose to induce inflammation and facilitate tissue repair, highlighting the importance of these mechanisms in treating Achilles Tendinopathy.

A role for substance P and acid-sensing ion channel 1a in prolotherapy with dextrose-mediated analgesia in a mouse model of chronic muscle pain.Saline vs. dextrose for local anesthetic dilution in brachial plexus block: A randomized study.In Vivo Toxicity of Local Anesthetics and Corticosteroids on Supraspinatus Tenocyte Cell Viability and Metabolism.