25 Participants Needed

Doxycycline for Tennis Elbow

JR
BI
Overseen ByBrianna I Quijano, MS
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Hospital for Special Surgery, New York
Must be taking: Doxycycline
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 doxycycline hyclate generally safe for humans?

Doxycycline hyclate has been used safely in humans for various conditions, but it can cause side effects like stomach issues, sensitivity to sunlight, and effects on tooth development in children. It is generally well tolerated in clinical trials, with most side effects being mild to moderate.12345

How does the drug Doxycycline Hyclate 20 MG differ from other treatments for tennis elbow?

Doxycycline Hyclate 20 MG is unique for tennis elbow as it is an antibiotic that may have anti-inflammatory properties, unlike traditional treatments like physiotherapy, steroid injections, or platelet-rich plasma therapy, which focus on reducing pain and promoting tendon healing through different mechanisms.678910

Who Is on the Research Team?

BG

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.
See 4 more

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.
See 11 more

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?
1Treatment groups
Experimental Treatment
Group I: SD-doxycycline groupExperimental Treatment1 Intervention
12 weeks SD-doxycycline: doxycycline hyclate 20 mg tablet by mouth twice daily

Find a Clinic Near You

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

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.
The use and safety of doxycycline hyclate and other second-generation tetracyclines.Sloan, B., Scheinfeld, N.[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.
Doxycycline 40 mg capsules (30 mg immediate-release/10 mg delayed-release beads): anti-inflammatory dose in rosacea.McKeage, K., Deeks, ED.[2022]
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.
The treatment of acne vulgaris with low dosage doxycycline.Parish, LC., Parish, JL., Routh, HB., et al.[2022]

Citations

The use and safety of doxycycline hyclate and other second-generation tetracyclines. [2022]
Doxycycline 40 mg capsules (30 mg immediate-release/10 mg delayed-release beads): anti-inflammatory dose in rosacea. [2022]
Pharmacokinetics of doxycycline and tissue concentrations of an experimental long-acting parenteral formulation of doxycycline in Wistar rats. [2013]
The treatment of acne vulgaris with low dosage doxycycline. [2022]
Recently approved systemic therapies for acne vulgaris and rosacea. [2013]
Duloxetine in treatment of refractory chronic tennis elbow: two case reports. [2021]
A rational management of tennis elbow. [2018]
The use of platelet-rich plasma therapy in treating tennis elbow: A critical review of randomised control trials. [2023]
[Short-term results of treatment of tennis elbow with anti-inflammatory drugs alone or in combination with local injection of a corticosteroid and anesthetic mixture]. [2019]
Tennis elbow: role of local steroid injection. [2014]
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