MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain
NCT ID: NCT03467165
Last Updated: 2023-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2019-04-27
2021-03-15
Brief Summary
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Detailed Description
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At any site, the vast majority of joint replacement surgery procedures are performed because of pain. MRgFUS has recently demonstrated a great potential in treating pain caused by different medical conditions, including osteoarthritis. The aim of the work is to study the feasibility, the safety and the potential efficacy of MRgFUS in treating pain from osteoarthritis in two "hot" spots: the hip and the trapeziometacarpal/scaphotrapezial joint.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hand ExAblate
MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)
MRgFUS treatment
MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)
Hip ExAblate
MRgFUS treatment of pain caused by hip OA
MRgFUS treatment
MRgFUS treatment of pain caused by hip OA
Interventions
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MRgFUS treatment
MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)
MRgFUS treatment
MRgFUS treatment of pain caused by hip OA
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
45 Years
90 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Principal Investigators
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Alberto Bazzocchi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Rizzoli Ortopaedic Institute
Locations
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Istituto Ortopedico Rizzoli
Bologna, BO, Italy
Countries
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Other Identifiers
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handhip@IORFus
Identifier Type: -
Identifier Source: org_study_id
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