About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
> 18 years of age undergone artery embolization interventions for the treatment of chronic pain due to osteoarthritis or other diagnoses that cause localized pain.
Disqualifiers
None
Trial 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.
Trial design
Other
Other
Treatments tested in this trial
Artery Embolization
Procedure/SurgeryEmbolic 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.
Treatment groups
Trial outcomes
Primary outcomes
Primary Outcome
Clinical success at 3 months, defined as improvement in Western Ontario and McMaster University (WOMAC) Pain Subscale from pre-operative/baseline WOMAC scores.
Primary Outcome
Clinical success at 3 months, defined as improvement of Visual Analog Scale (VAS) Scores from pre-operative/baseline scores.
Primary Outcome
Comparative assessment at 3 months of decreased use of medication prescribed at baseline to 3 months post operatively.
Primary Outcome
Clinical success at 3 months, as defined by improvement in the quality of life using the EQ-5D-5L Quality of Life Questionnaire compared to baseline.
Secondary outcomes
Secondary Outcome
Number of patients achieving clinical success at 1,3, 6, and 12-months post procedure.
Secondary Outcome
Decrease in Western Ontario and McMaster University (WOMAC) index compared to baseline, 1, 3, 6, and 12 months.
Secondary Outcome
Pain score assessed using Visual Analog Scale (VAS) Score from baseline, 1, 3, 6, and 12 months.
Secondary Outcome
Number of subjects who had pain reduction \>50% in the mean VAS pain scale at 1, 3, 6 and 12 months in comparison with baseline/preprocedural assessments.
Sponsors and contacts
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