Doxycycline for Tennis Elbow

Overseen By Brianna I Quijano, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hospital for Special Surgery, New York

Must be taking: Doxycycline

Must not be taking: Fluoroquinolones

Disqualifiers: Autoimmune, Pregnancy, Osteoarthritis, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a low-dose form of the antibiotic doxycycline can help manage tennis elbow, a common condition causing pain around the elbow joint. The research aims to determine if this treatment can improve outcomes by targeting enzymes linked to tissue damage. Researchers will also assess participants' adherence to the medication and exercise plan. Ideal candidates have experienced elbow pain related to tennis elbow for at least six weeks and feel pain during activities like gripping or wrist movements. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to explore its potential benefits.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking any medication that interacts with doxycycline. If you're on such a medication, you may need to stop it to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using a low dose of doxycycline to treat elbow tendinopathy is safe. Studies have found that patients generally tolerate this treatment well. Most participants in earlier research followed the treatment without major problems. Although this trial is in an early stage, with safety still being closely monitored, current evidence suggests that this low-dose method is practical and manageable for patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for tennis elbow?

Unlike the standard treatments for tennis elbow, which typically include physical therapy, NSAIDs, or corticosteroid injections, doxycycline hyclate offers a novel approach by being an oral antibiotic with potential anti-inflammatory properties. Doxycycline is traditionally used to fight bacterial infections, but in this context, it may help reduce inflammation in the affected tendons. Researchers are excited about this treatment because it could offer a non-invasive alternative that targets the underlying inflammation, possibly providing relief without the side effects associated with injections or long-term NSAID use.

What evidence suggests that this treatment might be an effective treatment for elbow tendinopathy?

Research has shown that a low-dose form of the antibiotic doxycycline might help with elbow tendinopathy, also known as tennis elbow. This trial will evaluate the effectiveness of this treatment, which reduces certain enzymes that can harm tissue. In earlier studies, most patients found this low-dose treatment safe and easy to use, adhering well to the treatment plan. If successful, this method might also assist with other types of tendinopathy. ^{2 3 4 5 6}

Who Is on the Research Team?

Brett G Toresdahl, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

I am a premenopausal woman not using birth control.

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

I am taking medication that interacts with doxycycline.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive doxycycline 20 mg BID for 12 weeks along with a home exercise program and a counterforce brace

12 weeks

4 visits (in-person) at baseline, 4, 8, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Doxycycline Hyclate 20 MG

Trial Overview 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.

How Is the Trial Designed?

Group I: SD-doxycycline group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Published Research Related to This Trial

In a 16-week study involving 12 participants with inflammatory acne, a maintenance dose of 20 mg of doxycycline hyclate taken twice daily was effective in maintaining improvement after an initial treatment phase.

After the first eight weeks of treatment with 100 mg daily, 11 out of 12 subjects showed a 50% reduction in acne lesions, and those who continued with the lower dose of doxycycline maintained their improvement, while the placebo group did not.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of acne vulgaris with low dosage doxycycline. Parish, LC., Parish, JL., Routh, HB., et al.[2022]

Anti-inflammatory dose doxycycline 40 mg capsules significantly improve rosacea symptoms compared to placebo, with a notable reduction in inflammatory lesions observed as early as 3 weeks into treatment, based on results from two large, randomized trials.

The 40 mg dose is effective without the higher concentrations needed for antibacterial effects, and it was well tolerated by patients, with most side effects being mild to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doxycycline 40 mg capsules (30 mg immediate-release/10 mg delayed-release beads): anti-inflammatory dose in rosacea. McKeage, K., Deeks, ED.[2022]

Tennis elbow, primarily caused by tendon injuries at the lateral epicondyle, is a common condition affecting about 50% of tennis players, with significant impact on daily activities for one-third of them.

Treatment should start conservatively with methods like cryotherapy, nonsteroidal anti-inflammatory drugs, and rest, as tennis elbow is largely self-limiting; invasive therapies should only be considered when benefits clearly outweigh risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A rational management of tennis elbow. Kamien, M.[2018]

Doxycycline hyclate (DH) has a favorable safety profile, especially in its delayed-release form (Doryx), compared to the standard powder form (Vibramycin), making it a safer option for treating conditions like acne and rosacea.

Despite historical safety concerns associated with tetracyclines, including gastrointestinal issues and effects on tooth development, subantimicrobial dosing of DH has shown to be effective and safe for acne treatment, supporting its continued use in dermatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use and safety of doxycycline hyclate and other second-generation tetracyclines. Sloan, B., Scheinfeld, N.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12434981/

Feasibility of subantimicrobial-dose doxycycline for elbow ... This study demonstrates that treatment of elbow tendinopathy with SD doxycycline is practical, feasible, and safe. The majority of patients were compliant with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04686799

NCT04686799 | Doxycycline for Elbow Tendinopathy Patient reported outcomes will include quick Disabilities of the Arm Shoulder and Hand score (qDASH) and Patient-Rated Tennis Elbow Evaluation (PRTEE) at ...

3. clinicaltrial.be clinicaltrial.be/en/details/49316?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&not_yet_recruiting=0&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Doxycycline for Elbow Tendinopathy If found to be beneficial for elbow tendinopathy, SD-doxycycline may have utility in other types of tendinopathy as well. Trial design.

4. withpower.com withpower.com/trial/phase-1-tennis-elbow-11-2020-48e07

Doxycycline for Tennis Elbow · Info for Participants This trial tests if a low dose of doxycycline can help adults with persistent elbow pain by reducing tissue-damaging enzymes.

5. ctv.veeva.com ctv.veeva.com/study/doxycycline-for-elbow-tendinopathy

Doxycycline for Elbow Tendinopathy - ClinicalTrials.Veeva To evaluate the feasibility of subantimicrobial -dose (SD) doxycycline to improve outcomes of nonsurgical management of elbow tendinopathy.

6. sciencedirect.com sciencedirect.com/science/article/pii/S266663832500101X

Feasibility of subantimicrobial-dose doxycycline for elbow ... This study demonstrates that treatment of elbow tendinopathy with SD doxycycline is practical, feasible, and safe. The majority of patients were compliant with ...