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Completed

NCT Number: NCT03467165

MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain

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.

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Key information

Conditions

Osteoarthritis Arthritis Hand Osteoarthritis Hip Osteoarthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis, Hip Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRgFUS Treatment

Device

MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)

Primary outcomes

  1. Changes in Pain Intensity from Baseline

    Time frame: Baseline (Day1), Week 1, 2, 3, Month 1, 2, 3, 6, 9, 12

    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').

  2. Incidence of Treatment-Related Adverse Events (Safety and Tolerability)

    Time frame: Through study completion, an average of 1 year

    Collecting the number of treatment-related adverse events

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 15, 2018
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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