Status:
COMPLETED
MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Osteoarthritis
Hip Osteoarthritis
Eligibility:
All Genders
45-90 years
Phase:
NA
Brief Summary
This project aims at performing a pilot study to provide data on safety and potential efficacy of Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) in the treatment of pain caused by trape...
Detailed Description
Pain caused by osteoarthritis is a matter of huge impact, in terms of quality of life, social and economic burden. Global aging of the population is going to worsen the problem. The hand is the most a...
Eligibility Criteria
Inclusion
- Male and female aged between 45 and 90 years
- Presence of activity-related joint pain
- Patients who have either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes
- Patients who have not responded to previous treatments,
- Patients with a baseline pain intensity of 4 to 8 on a 10-cm VAS
- Patients who are not candidates for immediate surgery
- Signed statement of informed consent (approved by Ethics Committee)
Exclusion
- Prior surgery or previous local treatment (infiltration, other) in the past 3 months
- Changes in medications used during the previous 2 months
- Intravenous drug use
- Corticosteroid use of more than 3 months within the preceding year
- Diagnosis of other rheumatologic disorders
- Trauma, fracture, or osteomyelitis of the investigated joints within the preceding year
- Any neurological disease or disorders potentially affecting pain perception
- Fibromyalgia
- Pregnancy
- Patients with large scar at skin or deeper soft tissue potentially included in the planned path of the ultrasound beam
- General contraindications to MRI and/or to anaesthesiological procedures planned for the patient
- Presence of internal hardware or devices potentially affecting MR thermometry
Key Trial Info
Start Date :
April 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03467165
Start Date
April 27 2019
End Date
March 15 2021
Last Update
May 11 2023
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, BO, Italy, 40136