MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain

Osteoarthritis Clinical Trial

Official title:

Magnetic Resonance Guided Focused Ultrasound Surgery: a Pilot Study in the Treatment of Pain Caused by Osteoarthritis - Hand and Hip, Challenging Joints

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467165
• Other study ID #: handhip@IORFus
• Status: Completed
• Phase: N/A
• Start date: April 27, 2019
• Est. completion date: March 15, 2021

Study information

• Verified date: March 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 trapeziometacarpal osteoarthritis (OA) and/or scaphotrapezial OA, and by hip OA, while exploring the potential application of MRgFUS to two different and central joints burdened by OA.

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 affected site in the upper limb, and involvement of the trapeziometacarpal joint is highly prevalent, with significant limitation of functionality when it happens. In the lower limb, the hip and the knee share the leading position in the clinical scenario, with the former being historically the most frequently submitted to joint replacement.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Hand Osteoarthritis
• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• MRgFUS treatment
MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)
• MRgFUS treatment
MRgFUS treatment of pain caused by hip OA

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Pain Intensity from Baseline	Changes in pain intensity from baseline will be determined by a straight horizontal 10-cm linear Visual Analog Pain Scale (VAS, scale 0-10 where 0 means 'no pain at all' and 10 means 'pain as bad as it could be').	Baseline (Day1), Week 1, 2, 3, Month 1, 2, 3, 6, 9, 12
Primary	Incidence of Treatment-Related Adverse Events (Safety and Tolerability)	Collecting the number of treatment-related adverse events	Through study completion, an average of 1 year