Genicular Embolization Using Doxycycline Sclerotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2029-06-30

Brief Summary

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The goal of this prospective case series is to develop an alternative pain management procedure for patients who are not surgical candidates. The main question it aims to answer is: Is genicular sclerotherapy using doxycycline a safe and effective pain management option for patients with chronic knee pain who are not surgical candidates?

OUTCOME MEASURES:

Primary: Visual Analog Scale (VAS) score at 3 months

Secondary:

* VAS at 12 months
* Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 months

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Detailed Description

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The purpose of this study is to develop an alternative pain management procedure for patients who are not surgical candidates. Using sclerotherapy (a procedure in which a medication is injected into small blood vessels causing them to scar, shrink and collapse) in the small terminal branches of some of the blood vessels in the knee, the aim is to adapt this proven therapy for varicose veins, cysts, and vascular malformations to pain management. Doxycycline will be used as the injectable to perform the procedure. Doxycyline is a FDA approved medication commonly used for bacterial infections and is is frequently used off-label as a sclerosing agent; however, it is not specifically FDA approved for use in sclerotherapy.

This is a pilot study. A pilot study is a small-scale, preliminary study conducted before a larger, more comprehensive research project. Its purpose is to test and refine the research methods, procedures, and instruments, ensuring they are feasible, practical, and reliable.

Visit 1: Consent and treatment procedure: Subjects will be consented and baseline VAS (visual analog scale) and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)will be obtained. Procedure will be performed by one of the study providers as follows: Following sterile cleaning of the skin and administration of lidocaine to anesthetize injection tract, ultrasound guidance will be utilized to isolate target sites of the peripheral vasculature of the genicular artery in one knee. Up to four sites in the index knee may be injected as needed based on pain presentation and physician's discretion. A maximum of 100 milligrams of doxycycline diluted in 10 milliliters of sterile water will be used per subject. Post procedure icing will be performed for 15 minutes to help prevent the occurrence of ischemia and bruising.

Post-operatively, a prescription for either Lortab or Tramadol will be offered and an over the counter pain medication option will be recommended.

If the subject experiences an adverse event, please contact the study provider for an exam, lab-work and/or consultation as needed.

Following the procedure, restrict activity for 1-2 weeks to protected weight bearing and to advance as tolerated.

Visit 2: 2 weeks post-op: Follow up appointment in clinic with provider. VAS and WOMAC will be collected. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.

Visit 3: 6 weeks post-op: Follow up appointment in clinic with provider. VAS and WOMAC will be collected. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.

Visit 4: 3 months post-op: Follow up appointment in clinic with provider. VAS and WOMAC will be collected. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.

Visit 5: 6 months post-op: VAS and WOMAC will be collected over the phone. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.

Visit 6: 9 months post-op: VAS and WOMAC will be collected over the phone. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.

Visit 7: 12 months post-op: VAS and WOMAC will be collected over the phone. Any problems/concerns the patient may be having and if the subject is considering seeking other treatment will be discussed and documented.

Conditions

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Chronic Knee Pain Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single-group, prospective interventional pilot study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Doxycycline Genicular Sclerotherapy Arm

Participants in this arm will undergo sclerotherapy using doxycycline to target terminal genicular arteries associated with knee pain. The procedure is performed under ultrasound guidance, and the goal is to evaluate the safety and potential efficacy of doxycycline as a sclerosing agent for managing chronic knee pain symptoms.

Group Type EXPERIMENTAL

Doxycycline Injection

Intervention Type DRUG

Injection of doxycycline as a sclerosing agent into the genicular artery region under ultrasound guidance for the purpose of evaluating its effectiveness in reducing knee pain.

Interventions

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Doxycycline Injection

Injection of doxycycline as a sclerosing agent into the genicular artery region under ultrasound guidance for the purpose of evaluating its effectiveness in reducing knee pain.

Intervention Type DRUG

Other Intervention Names

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Ultrasound Guided Sclerotherapy

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age or older.
* KL Score 2-3
* VA Grade \>5
* Native knee
* Willing and able to provide consent.
* Willing and able to complete questionnaires.
* Willing and able to complete follow up visits.
* Speak and write fluent English
* Unilateral knee (if bilateral knee pain, identify knee for procedure)
* All subjects may be included regardless of sex. Women must be either surgically sterilized postmenopausal defined as having no menstrual periods for 12 consecutive months

Exclusion Criteria

* Allergies to doxycycline or any other substances used in procedure
* Steroid injection in the index knee within the last 90 days
* Knee surgery on index knee in the last 180 days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No