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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-80
SponsorPalo Alto Veterans Institute for Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

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

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

Disqualifiers

Acute injury in the last 12 weeks.

Age under 25.

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

History of arthroplasty or metallic implant within the painful joint.

Trial population

Participants will be veterans eligible for care at the VA. Anticipated age range is 25-80. Gender will be predominantly male (approximately 90%), concordant with demographic information of the VA population. Pregnant women, children, vulnerable subjects, study personnel and students will not be eligible for enrollment.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Shoulder/Hip/Knee Embolization with Embozene Microspheres

    Device

    Fluoroscopically-guided arterial embolization of synovitis in the painful shoulder, hip or knee.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Diagnostic0 interventions
Group B: Therapeutic1 intervention

Trial outcomes

Primary outcomes

1

Primary Clinical Outcome (Hip and Knee, Therapeutic Arm Only)

Composite WOMAC survey score

Time frame
Score obtained at follow-up visit 6 months after intervention
2

Primary Clinical Outcome (Shoulder, Therapeutic Arm Only)

Composite WORC survey score

Time frame
Score obtained at follow-up visit 6 months after intervention
3

Primary Imaging Outcome (Therapeutic Arm Only)

Quantitative perfusion parameters (Ktrans, mean transit time, fractional extracellular volume, time-to-peak)

Time frame
Research MRI obtained 3 months after intervention

Secondary outcomes

1

Secondary Clinical Outcome (Hip and Knee, Diagnostic Arm Only)

Composite WOMAC survey score

Time frame
Score obtained at follow-up visit after 12 months
2

Secondary Clinical Outcome (Shoulder, Diagnostic Arm Only)

Composite WORC survey score

Time frame
Score obtained at follow-up visit after 12 months
3

Secondary Imaging Outcome (Diagnostic Arm Only)

Quantitative perfusion parameters (Ktrans, mean transit time, fractional extracellular volume, time-to-peak)

Time frame
Research MRI obtained after 12 months of follow-up
4

Secondary Imaging Outcome 2 (Diagnostic Arm Only)

Quantitative cartilage mapping parameters (T1rho, T2) in milliseconds averaged over manually segmented cartilage for each joint (shoulder, hip or knee)

Time frame
Research MRI obtained after 12 months of follow-up

Other outcomes

Sponsors and contacts

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