A new nonsurgical treatment may help reduce pain and improve function in patients with adhesive capsulitis, also known as “frozen shoulder,” according to research presented during a virtual session of the Society of Interventional Radiology’s 2020 Annual Scientific Meeting on June 13.
Frozen shoulder is most common in people in their 50s and 60s, and women are more often affected than men. Frozen shoulder often happens as a result of a shoulder injury (such as a rotator cuff tear), a bone fracture affecting the shoulder, or shoulder surgery. It can also happen after people have other types of surgery, such as heart or brain surgery.
Frozen shoulder gradually causes significant pain and stiffness of the shoulder joint in an estimated 200,000 people in the U.S. each year. The symptoms are often treated with physical therapy or pain medications, until they resolve within one to three years.
In this Phase II FDA-approved Investigational Device Exemption clinical trial on arterial embolization of the shoulder (AES), interventional radiologists inserted a catheter through a pinhole-sized incision in patients’ wrists that was used to feed microsphere particles into as many as six arteries in the shoulder to reduce inflammation. The treatment was conducted on an outpatient basis and took approximately one hour. Each patient’s pain, disability, and blood flow in the shoulder were measured before and after the treatment using three scales, in addition to MRI imaging to visualize the shoulder joint.
The treatment was successfully completed in 16 patients whose symptoms had not responded to conservative treatment over 30 days. Minor adverse events such as temporary skin discoloration were reported in nine patients. One month later, researchers followed the progress of 11 patients and found that pain significantly decreased after AES (-57 mm on the Visual Analog Scale) and improved physical function in all patients (+28 mm on the Single Assessment Numeric Evaluation and +30 mm on the American Shoulder and Elbow Surgeons Shoulder Score). Additional progress was reported at the three-month follow up.
The research was conducted as a collaboration between interventional radiology and orthopedic surgery to build on international studies of the procedure by adapting the treatment design and embolic agent to be more durable.