Clinical trial NCT07024654: A Prospective Case Series: Genicular Embolization Using Doxycycline Sclerotherapy
Official title: A Prospective Case Series: Genicular Embolization Using Doxycycline Sclerotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Chronic Knee Pain
Osteoarthritis
Keywords: Chronic knee pain
osteoarthritis
genicular sclerotherapy
Lead sponsor: Campbell Clinic
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-group, prospective interventional pilot study
Primary purpose: TREATMENT

Brief summary: 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 (WOMAC) score at 12 months

Detailed description: 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 and WOMAC 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.

Eligibility criteria: 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) Women who are 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

Primary outcomes:
measure: VAS
timeFrame: 3 months post-op
Secondary outcomes:
measure: WOMAC
timeFrame: 1 year post-op
measure: VAS
timeFrame: 1 year post-op
Other outcomes:
Locations:
Study officials:
affiliation: Campbell Clinic
name: Joshua Brandon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bountouroglou DG, Azzam M, Kakkos SK, Pathmarajah M, Young P, Geroulakos G. Ultrasound-guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins: early results of a randomised controlled trial. Eur J Vasc Endovasc Surg. 2006 Jan;31(1):93-100. doi: 10.1016/j.ejvs.2005.08.024. Epub 2005 Oct 17.
citation: Wong MN, Murakami JW. Doxycycline Sclerotherapy of Mandibular Aneurysmal Bone Cysts: A Brief Clinical Study. J Craniofac Surg. 2025 Jan-Feb 01;36(1):e31-e33. doi: 10.1097/SCS.0000000000010697. Epub 2024 Sep 23.
citation: McDermott D, Wakefield D, Kowalsky M, Sethi P, Vitale MA, Morrey BF. Intrabursal Doxycycline Sclerotherapy for Recurrent Olecranon Bursitis of the Elbow: A Case Control Study. J Hand Surg Glob Online. 2024 Apr 8;6(4):504-509. doi: 10.1016/j.jhsg.2024.03.006. eCollection 2024 Jul.
citation: Liu S, Swilling D, Morris EM, Macaulay W, Golzarian J, Hickey R, Taslakian B. Genicular Artery Embolization: A Review of Essential Anatomic Considerations. J Vasc Interv Radiol. 2024 Apr;35(4):487-496.e6. doi: 10.1016/j.jvir.2023.12.010. Epub 2023 Dec 19.
citation: Torkian P, Golzarian J, Chalian M, Clayton A, Rahimi-Dehgolan S, Tabibian E, Talaie R. Osteoarthritis-Related Knee Pain Treated With Genicular Artery Embolization: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2021 Jul 14;9(7):23259671211021356. doi: 10.1177/23259671211021356. eCollection 2021 Jul.
citation: van Zadelhoff TA, Moelker A, Bierma-Zeinstra SMA, Bos PK, Krestin GP, Oei EHG. Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial. Trials. 2022 Jan 8;23(1):24. doi: 10.1186/s13063-021-05942-x.