"This is one of the most frustrating complaints that patients have as they get older." Physicians are testing two drugs approved to treat other conditions to see whether they might also help patients who have severe pain in their lower back and in their legs.
The research studies at the University of Rochester Medical Center are part of an effort to come up with new treatments for pain caused by a condition known as lumbar spinal stenosis. Doctors are looking for up to 75 people to take part in the studies.
Lumbar spinal stenosis is the most common reason that people older than 65 choose to have back surgery. Nerve roots in the spinal canal are put under pressure as age causes the bones in our back to degenerate. The pressure on the nerves results in pain, sometimes very severe, in the lower back and the legs when patients stand or walk.
Doctors turn to a variety of drugs to treat the pain, but no drug has ever been proven to relieve the pain effectively. Even the most effective solution, surgery, does not significantly relieve pain in approximately one-third of patients. A study recently published in the New England Journal of Medicine found that the pain relief experienced by many patients after surgery often did not translate into better mobility and function in their daily lives.
Neurologist John Markman, M.D., assistant professor and director of Translational Pain Research in the Department of Neurosurgery, designed the new studies to study the benefit of non-surgical treatments.
"This can be a very painful condition, and one that unfortunately limits many older people from being as active as they otherwise could be," Markman said. "The spinal canal often narrows with age, and the distance that people can tolerate walking gets shorter and shorter. It's one of the most frustrating complaints that patients have as they get older."
Markman is beginning two new research studies. In one study funded by Endo Pharmaceuticals, he is studying whether the company's medication Opana helps reduce pain and improve the mobility of patients with the condition compared to a placebo or to another commonly used pain medication. While Opana is now used to treat people with chronic spinal pain, Markman will measure if the medication actually improves the ability of patients to move around in their everyday lives.
In a second study, Markman will look at the use of a medication known as Lyrica to treat the nerve injury pain associated with lumbar spinal stenosis. The study is funded by Pfizer, which sells Lyrica for use in treating severe nerve pain from such disorders as shingles and fibromyalgia.
In both studies, the key measure will be whether the medications increase patients' ability to stand longer and walk further with less pain. Markman will measure the effects of the medication as patients walk on a treadmill.
"This approach looks at a person's real-life experience of pain and measures not only the intensity of discomfort, but how much it interferes with basic activities. Can you walk to the mailbox? Can you stand long enough to prepare a meal or wash the dishes? This is the type of information patients need to know when trying to figure out if taking a medication is worthwhile," said Markman.
The studies are funded by a total of approximately $350,000 from the two companies.
Anyone with lumbar spinal stenosis who is interested in taking part in one of the studies should call (585) 276-3551 or (585) 276-3224.