Drug provides alternative therapy for chronic shoulder pain

Sodium hyaluronate effectively reduced chronic pain due to shoulder osteoarthritis by half.

A new study by researchers at Columbia University Medical Center in New York shows that sodium hyaluronate may be effective for relieving osteoarthritis-related shoulder pain.

Theodore Blaine, MD, an assistant professor of orthopedic surgery at the center and an attending surgeon at New York-Presbyterian Hospital, presented the study results at the American Academy of Orthopaedic Surgeons 73rd Annual Meeting in Chicago.

In their study, Blaine and colleagues found that sodium hyaluronate effectively reduced chronic pain due to shoulder osteoarthritis (OA) by 50%, according to a news release. The results were comparable to those of a 1998 study that led to FDA approval of the drug for treating OA knee pain.

The FDA is currently reviewing the results in shoulder pain, according to the release.

“Chronic shoulder pain is a common problem that can not adequately be treated with existing FDA-approved therapies,” Blaine said in the release. “The results of the trial were very encouraging, and we hope they will lead to this drug’s approval as an effective therapy for thousands of suffering patients.”

Failing nonsurgery treatment

Prior to the study, patients had failed nonsurgical clinical interventions, including physical therapy, at least one steroid injection and various oral pain medications. Also, 60% of patients were taking cardiac medications, about 55% took COX-2 inhibitors prior to joining the study, and up to 14% were taking medication for diabetes.

At baseline, the researchers radiographically confirmed the diagnosis of OA and ruled out fractures or other exclusionary criteria. An MRI was also taken to diagnose soft tissue and bony pathology or rotator cuff tears.

The study included 602 patients assigned to one of three groups. One group received five injections of the drug over six months. The second group received three injections, followed by two saline injections, and the third group received five placebo injections of saline.

Patients recorded their pain level over six month's follow-up using a scale from one to 100, with 100 being most severe, according to the release.

All three groups had a mean baseline score of 56. At six months’ follow-up, patients treated with sodium hyaluronate had the highest decrease in pain, with a mean score of 35. Also at six months, mean pain score improved to 37 among patients treated with three sodium hyaluronate injections, and placebo-treated patients had a mean score of 43, according to the release.

The improvement seen in the placebo group could be the result of the placebo effect as well as the possible therapeutic benefit of irrigating the joint. Similar saline results were seen in the FDA knee OA study.

For more information:
Blaine TA, Skyhar MJ, Collins PC, et al. Double-blind, randomized trial of IA sodium hyaluronate (Hyalgan) for chronic shoulder pain. #426. Presented at the American Academy of Orthopaedic Surgeons 73rd Annual Meeting. March 22-26, 2006. Chicago.