Clinical trial NCT06477965: Embo Registry; National Registry for Artery Embolization
Official title: Multicenter National Registry for Artery Embolization (Embo Registry) for the Treatment of Osteoarthritis and Areas of Localized Pain to Assess Treatment of Artery Embolization to Determine If Subjects Have Decrease Pain, Decreased Use of Narcotics and NSAIDs, and Quality of Life Improvement Post Procedure.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Osteoarthritis, Knee
Osteoarthritis Thumb
Osteoarthritis Shoulder
Pain, Chronic
Tendonitis Elbow
Tendonitis Shoulder
Tendonitis;Achilles
Tenosynovitis
Keywords: Pain
Osteoarthritis
Arthritis
Tendonitis
Tenosynovitis
Lead sponsor: Vascular Solutions of North Carolina
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic and localized pain from diagnoses such as osteoarthritis, tendonitis, tenosynovitis, or injury who underwent Artery Embolization for the treatment of their symptoms/pain.

Brief summary: Embo Registry is a retrospective and prospective observational study to evaluate real world effectiveness and the use of Artery Embolization as a treatment for chronic pain with patients that have osteoarthritis and localized pain to provide symptomatic relief. This study is to determine the efficacy and validity of procedure and that following procedure patients had decreased pain and improved quality of life.

Detailed description: Embolic Solution are intended for use in occluding blood vessels for therapeutic or operative purposes. The embolic solution is used during an outpatient procedure, the physician will insert a small catheter onto the artery supplying the lining of the target joint or target localized pain. Tiny particles are then injected through the catheter into these arteries, reducing blood flow to the target area. This reduces the amount of inflammation associated with osteoarthritis, tendonitis, tenosynovitis or an injury, a process that can help decrease symptoms or eliminate the associated localized pain to this area. With understanding that it does not treat the underlying cartilage destruction or underlying condition causing pain but would like to determine the efficacy and validity of this treatment. For the study to determine efficacy and overall improvement of patients post procedure by comparing patient's pain preoperative and post operatively, if there is a decreased use of medication preoperatively compared to post procedure and increased quality of life preoperative and post procedure. Clinical outcomes of improvement will be determined by improvement of Visual Analog Scale (VAS) scores, Western Ontario and McMaster Universities Index (WOMAC), EQ-5D-5L Quality of Life Questionnaire, and to determine if patients had decrease used of medication prescribed preoperatively.

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age undergone artery embolization interventions for the treatment of chronic pain due to osteoarthritis or other diagnoses that cause localized pain.

Exclusion Criteria:

* None

Primary outcomes:
measure: Primary Outcome
timeFrame: 3 months
measure: Primary Outcome
timeFrame: 3 months
measure: Primary Outcome
timeFrame: 3 months
measure: Primary Outcome
timeFrame: 3 months
Secondary outcomes:
measure: Secondary Outcome
timeFrame: 12 months
measure: Secondary Outcome
timeFrame: 12 months
measure: Secondary Outcome
timeFrame: 12 months
measure: Secondary Outcome
timeFrame: 12 months
measure: Secondary Outcome
timeFrame: 12 months
measure: Secondary Outcome
timeFrame: 12 months
measure: Secondary Outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: Cary
country: United States
facility: Vascular Solutions of North Carolina
state: North Carolina
city: Winchester
country: United States
facility: Southern Tennessee Cardiology
state: Tennessee
Study officials:
affiliation: Vascular Solutions of North Carolina
name: Siddhartha Rao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vascular Solutions of North Carolina
name: Amer Iqbal
role: STUDY_DIRECTOR
affiliation: Vascular Solutions of North Carolina
name: Meaghan Thomas, CCRP
role: STUDY_CHAIR
References: