Clinical trial NCT03467165: MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain
Official title: Magnetic Resonance Guided Focused Ultrasound Surgery: a Pilot Study in the Treatment of Pain Caused by Osteoarthritis - Hand and Hip, Challenging Joints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Hip Osteoarthritis
Hand Osteoarthritis
Keywords: MRgFUS
Pain
Hip
Trapeziometacarpal joint
Osteoarthritis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 14
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Pain Intensity from Baseline
timeFrame: Baseline (Day1), Week 1, 2, 3, Month 1, 2, 3, 6, 9, 12
measure: Incidence of Treatment-Related Adverse Events (Safety and Tolerability)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
Study officials:
affiliation: The Rizzoli Ortopaedic Institute
name: Alberto Bazzocchi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: