Perfusion MRI-targeted Joint Embolization for Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee

Osteoarthritis, Knee Clinical Trial

— MRI  

Official title:

Perfusion MRI-targeted Joint Embolization to Diagnose and Treat Neovascularity Associated With Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee: A Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05700682
• Other study ID #: 66820
• Status: Not yet recruiting
• Start date: March 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: January 2023
• Source: Palo Alto Veterans Institute for Research
• Contact: Eric Bultman, MD, PhD
• Phone: 560-493-5000
• Email: eric.bultman1[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this work the investigators will study the relationship between chronic musculoskeletal pain and abnormal blood flow (neovascularity) around the shoulder, hip and knee. Veterans with as history of chronic shoulder, hip or knee pain and mild/moderate joint degenerative changes will be potential study subjects. Blood flow around joints will be evaluated using perfusion magnetic resonance imaging (MRI). Participants with demonstrably abnormal blood flow around their painful joint will be eligible for enrollment in a pilot study of joint embolization to treat their pain. Participants who choose to not undergo treatment will be re-assessed with MRI after one year to characterize the natural history of joint neovascularity and its relationship to pain.

Description:

1. Joint MRI (shoulder, hip, knee) is ordered by a clinical provider due to ongoing/chronic joint pain. At the time of MR exam protocoling, investigators review prior imaging and determine that the patient has mild-moderate osteoarthritis. Patient is identified as a potential participant and is sent a letter by physical mail or e-mail (signed by PIs) discussing the research project. Subsequently, the clinical research coordinator reaches out to the potential participant by phone 7-14 days before the date of the MR exam to assess interest in the study.

2. Participant is interested and enrolls in the Diagnostic Arm of the study. Upon enrollment, the participant will undergo perfusion MRI and cartilage parameter mapping at the time of the initial MR exam (a 15-minute "add on" scan with Multihance intravenous contrast at the end of the standard clinical MRI). The participant will also complete a WOMAC (knee/hip) or WORC (shoulder) survey to document the baseline characteristics of their pain.

3. If there is NO neovascularity on the perfusion MRI, the participant will remain in the Diagnostic Arm of the study. Participants who remain in the Diagnostic Arm will undergo follow-up WOMAC surveys at 6 months / 1 year; and a research perfusion MR at one year. Follow-up data from the 1-year visit will represent the primary clinical and imaging endpoints of the Diagnostic Arm.

4. If neovascularity is present, the participant will be offered enrollment into the Therapeutic Arm. Participants not interested in the Therapeutic Arm will remain in the Diagnostic Arm.

5. Participants who elect to enroll in the Therapeutic Arm of the study are referred to the study investigators, who will screen for exclusion criteria. Importantly, if the participant has risk factors for or confirmed peripheral arterial disease (PAD), they must undergo CT angiography of the relevant anatomy (abdomen/pelvis with or without lower extremity runoff). If the participant does not meet any exclusion criteria, they will be scheduled for embolization therapy of their painful joint (shoulder, hip or knee). The participant will undergo embolization under fluoroscopic guidance using Embozene microspheres. Briefly, the relevant arterial vessels supplying the joint of interest will be accessed with an arterial catheter. The presence of abnormal peri-articular vessels seen on MRI will be confirmed during fluoroscopic imaging with injection of contrast material (Omnipaque). These abnormal vessels will then be embolized via careful injection of bland embolic particles (Embozene microspheres). After embolization, participant will attend one clinic follow-up visit at 2 weeks to screen for side effects or complications. The participant will be surveyed for their symptoms (WOMAC/WORC) at 1, 3, 6 and 12-months post-treatment. They will undergo research MR exams perfusion and cartilage parameter mapping at 3- and 12-months post-treatment.

6. Recruitment will occur over 1.5 years. Follow-up in both Arms will occur over 1 year. After completion of the study, the investigators anticipate approximately 3-4 months will be required for data analysis and manuscript preparation. Total study duration will therefore be 2.5 to 3 years.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria (Both Arms):

1. Participants must be Veterans who receive care in the VA system.

2. Participants must have a history of chronic pain of the shoulder, hip or knee for at least 1 year.

3. Participants must have mild to moderate degenerative changes of the painful joint as depicted on prior imaging (X-ray, CT or MRI).

4. Participants must have undergone at least one failed primary treatment for their chronic pain (e.g. physical therapy, NSAIDs, steroid injection).

5. Participants must have an MRI of their painful joint (shoulder, hip or knee) ordered by a clinical provider.

Inclusion Criteria (Therapeutic Arm):

1. Participants must have enrolled in the Diagnostic Arm of the study and must have undergone perfusion MR imaging of their painful joint.

2. Participants must have evidence of peri-articular hypervascularity on their perfusion MR exams. This will be determined by the study PIs.

Exclusion Criteria (Diagnostic Arm):

1. Acute injury in the last 12 weeks.

2. Age under 25.

3. Severe degenerative changes of painful joint (shoulder, hip or knee).

4. History of arthroplasty or metallic implant within the painful joint.

5. Severe gadolinium contrast allergy.

6. Severe renal disease or ongoing dialysis.

7. History of malignancy with life expectancy of less than one year, or malignancy with known bone metastasis.

8. Current pregnancy.

9. Formal diagnosis of cognitive impairment.

Exclusion Criteria (Therapeutic Arm):

1. Severe iodinated contrast allergy.

2. Severe coronary or peripheral arterial disease.

3. Coagulopathy.

4. Uncontrolled type 2 diabetes or diabetic neuropathy.

5. History of seizures or other severe complication from conscious sedation.

6. Prior upper or lower extremity arterial bypass.

7. Ongoing participation in another interventional (therapeutic) trial for chronic joint pain.

8. Lack of peri-articular hypervascularity on initial perfusion MRI.

9. All exclusion criteria for the Diagnostic Arm.

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain
• Osteo Arthritis Shoulders
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee
• Pain, Chronic
• Synovitis
• Synovitis of Knee
• Tenosynovitis

Intervention

Device:
• Shoulder/Hip/Knee Embolization with Embozene Microspheres
Fluoroscopically-guided arterial embolization of synovitis in the painful shoulder, hip or knee.

Locations

Country	Name	City	State
United States	VA Palo Alto Healthcare System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	Varian

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Clinical Outcome (Hip and Knee, Therapeutic Arm Only)	Composite WOMAC survey score	Score obtained at follow-up visit 6 months after intervention
Primary	Primary Clinical Outcome (Shoulder, Therapeutic Arm Only)	Composite WORC survey score	Score obtained at follow-up visit 6 months after intervention
Primary	Primary Imaging Outcome (Therapeutic Arm Only)	Quantitative perfusion parameters (Ktrans, mean transit time, fractional extracellular volume, time-to-peak)	Research MRI obtained 3 months after intervention
Primary	Primary Imaging Outcome (Therapeutic Arm Only)	Quantitative cartilage mapping parameters (T1rho, T2) in milliseconds averaged over manually segmented cartilage for each joint (shoulder, hip or knee)	Research MRI obtained 3 months after intervention
Secondary	Secondary Clinical Outcome (Hip and Knee, Diagnostic Arm Only)	Composite WOMAC survey score	Score obtained at follow-up visit after 12 months
Secondary	Secondary Clinical Outcome (Shoulder, Diagnostic Arm Only)	Composite WORC survey score	Score obtained at follow-up visit after 12 months
Secondary	Secondary Imaging Outcome (Diagnostic Arm Only)	Quantitative perfusion parameters (Ktrans, mean transit time, fractional extracellular volume, time-to-peak)	Research MRI obtained after 12 months of follow-up
Secondary	Secondary Imaging Outcome (Diagnostic Arm Only)	Quantitative cartilage mapping parameters (T1rho, T2) in milliseconds averaged over manually segmented cartilage for each joint (shoulder, hip or knee)	Research MRI obtained after 12 months of follow-up