A 76-year-old man suffering from agonising post-stroke shoulder pain for more than ten years is now pain-free, thanks to the world’s first implantation of an investigational pain therapy device.
The implant produced by SPR Therapeutics was placed at Carolinas Medical Center and the patient was treated at Carolinas Rehabilitation in Charlotte, North Carolina, USA, as part of a multicentre clinical study for the treatment of post-stroke shoulder pain sponsored by NDI Medical, also involving MossRehab in Philadelphia, Weill Cornell Medical Center in New York City, and MetroHealth Medical Center in Cleveland.
“This is the first promising pain treatment technology designed to reduce or eliminate the excruciating shoulder pain that many stroke survivors suffer from,” said Vu QC Nguyen, director of Stroke Rehabilitation at Carolinas Rehabilitation and principal investigator of the clinical study. “This study will enable us to evaluate whether this advanced technology has come up to the level to meet our patients’ needs.”
The study participant was given SPR’s short-term, temporary therapy in September 2010 which significantly reduced his pain after just a few weeks. In December 2011, William Bock, cardiologist at Carolinas Medical Center then implanted the device in the patient, who was pain-free within a few weeks of this surgery. He has been pain-free since then, except for a short period in February through April 2011 when the system was turned off due to an unrelated illness. Within a few weeks of the system being turned back on, the patient’s shoulder pain was completely eliminated.
The patient’s overall quality of life has also improved, including improvements in his sleep, mood, and relationships with others, according to study measures. The clinical study is evaluating the safety and effectiveness of this fully implantable therapy in a group of subjects with post-stroke shoulder pain, and the results experienced by the first subject are very encouraging.
The SPR System could “potentially revolutionise the treatment of chronic shoulder pain,” according to John Chae, SPR Therapeutics’ chief medical advisor and professor of Physical Medicine and Rehabilitation at Case Western Reserve University and MetroHealth Medical Center. “Additional studies are being initiated to evaluate this therapy in subjects with shoulder pain that is not related to stroke.”
Shoulder pain is a common complication following stroke, affecting almost one third of stroke survivors. Yet, post-stroke shoulder pain has not been adequately addressed by traditional treatment options such as local injections, oral analgesics, physical and occupational therapies, acupuncture, and surface neuromuscular electrical stimulation.
The investigational SPR system uses a proprietary method of Intramuscular Nerve (IMN) therapy which stimulates peripheral nerves within muscle to treat pain, and is being studied in patients who are unresponsive to or cannot tolerate these conventional therapies. There are risks associated with participating in the study and receiving the SPR system, and study subjects are informed of all the potential risks before enrolling in the study.
“The implantation of our first fully implantable SPR system for chronic pain is a significant milestone for the treatment of post-stroke shoulder pain and potentially other pain indications in the future,” said Maria Bennett, president and CEO of SPR therapeutics.