unable to obtain IND approval from FDA

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

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.

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