What side effects are associated with this type of intervention?

Common treatments for Tennis Elbow include corticosteroid injections, physiotherapy, and oral antibiotics like doxycycline. Doxycycline, particularly in subantimicrobial doses aimed at inhibiting matrix metalloproteinases (MMPs), can cause side effects such as gastrointestinal disturbances, photosensitivity, and potential interactions with other medications like warfarin and oral contraceptives. Corticosteroid injections, while effective for short-term pain relief, may lead to side effects such as skin thinning, increased pain, and potential tendon rupture with repeated use.

What prior FDA approvals exist?

The provided context does not mention any specific FDA approvals for the treatment of Tennis Elbow (lateral epicondylitis) using subantimicrobial-dose doxycycline or other MMP inhibitors. Generally, treatments for Tennis Elbow include nonsteroidal anti-inflammatory drugs (NSAIDs), physical therapy, corticosteroid injections, and in some cases, surgical intervention. The trial mentioned is exploring the feasibility of using subantimicrobial-dose doxycycline to improve outcomes by inhibiting MMPs, which is a novel approach not yet reflected in existing FDA approvals.

What other types of research exist?

Promising novel alternatives to subantimicrobial-dose doxycycline for Tennis Elbow patients include Aflapin®, a Boswellia Serrata extract, which has demonstrated significant improvements in pain and inflammation in osteoarthritis patients. Additionally, treatments targeting MMP inhibition or anti-inflammatory pathways, such as certain biologics or advanced NSAIDs, may also be considered.

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Tetracycline Antibiotic

Doxycycline for Tennis Elbow

Phase 1

Waitlist Available

Led By Brett G Toresdahl, MD

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

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

Must have

Atraumatic unilateral elbow pain of ≥ 6 weeks duration

Pain with gripping and/or resisted wrist extension with the elbow extended

Must not have

Premenopausal women who are not using contraception

Separate upper extremity injury or condition that would interfere with full participation in the home exercise program

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a low dose of doxycycline can help adults with persistent elbow pain by reducing tissue-damaging enzymes. Tetracyclines, including doxycycline, have been shown to reduce these enzymes and may offer additional benefits. The goal is to find a more effective and affordable treatment for those who don't respond well to usual care.

Who is the study for?

This trial is for men and women over 18 with elbow tendinopathy, which includes golfer's or tennis elbow that's been painful for at least 6 weeks. Participants need internet access and haven't had surgery on the affected elbow. Pregnant individuals, those not using contraception, non-English speakers, or people with certain medical conditions are excluded.

What is being tested?

The study tests if a low-dose antibiotic called Doxycycline can help improve elbow tendinopathy by inhibiting enzymes that break down tissue. It also checks if patients will follow the medication and exercise regimen prescribed.

What are the potential side effects?

Doxycycline may cause side effects like digestive issues (esophagitis or ulcers), reactions in those allergic to tetracyclines, and potential drug interactions. Specific side effects related to tendon health aren't mentioned but could be monitored.

Eligibility Criteria

Inclusion Criteria

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

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I have had elbow pain for 6 weeks or more without injury.

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I experience pain when I grip something or extend my wrist with my arm straight.

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I experience pain when my wrist and fingers are bent back with my arm straight.

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I have elbow pain on the inner or outer side.

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I experience elbow pain when I move or use my arm.

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I have been diagnosed with tennis elbow or golfer's elbow.

Exclusion Criteria

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

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I am a premenopausal woman not using birth control.

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I do not have an arm injury that would stop me from doing home exercises.

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I am taking medication that interacts with doxycycline.

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I have had shockwave therapy on my elbow before.

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I have had surgery on my elbow before.

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I do not speak English.

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I have current esophagitis or peptic ulcer disease.

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I have had an injection in the elbow area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primarily a feasibility study of SD-doxycycline as an adjunctive treatment for elbow tendinopathy (Compliance)

Receptiveness

Secondary study objectives

Clinical outcomes - Grip strength

Clinical outcomes - MMP

Clinical outcomes - PRTEE

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SD-doxycycline groupExperimental Treatment1 Intervention

12 weeks SD-doxycycline: doxycycline hyclate 20 mg tablet by mouth twice daily

0 / 14Eligibility 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

Common treatments for Tennis Elbow include physical therapy, corticosteroid injections, and investigational treatments like subantimicrobial-dose doxycycline. Physical therapy works by strengthening and stretching the affected muscles and tendons, promoting healing and reducing pain. Corticosteroid injections provide short-term pain relief by reducing inflammation but may have negative long-term effects. Subantimicrobial-dose doxycycline, which inhibits matrix metalloproteinases (MMPs), aims to reduce tissue degradation and inflammation, potentially offering a novel approach to managing chronic tendinopathy. Understanding these mechanisms helps patients and doctors choose treatments that not only alleviate symptoms but also address underlying tissue damage, improving long-term outcomes.

Treating lateral epicondylitis with corticosteroid injections or non-electrotherapeutical physiotherapy: a systematic review.