Sciatica nerve pain study seeks volunteers

School of Medicine researchers are testing the effectiveness of an investigational drug for the treatment of sciatica pain.

Sciatica involves pain in the lower back and hip that radiates down the thigh into the leg. It usually is caused by a combination of compressed nerve roots in the spinal cord and inflammation in the sciatic nerve and often occurs with inflamed or herniated disks.

Pain from sciatica is called neuropathic pain because it is caused by damage to the nervous system. Many new therapies have been introduced to treat neuropathic pain, but not all patients benefit from existing therapies. The study is recruiting people with sciatica pain due to inflamed nerve roots in the lower back.

“Patients with sciatica often refer to their problem as a shooting pain like electricity down the leg,” said principal investigator Rahul Rastogi, M.D., instructor of anesthesiology, who sees patients at the Pain Management Center. “Sometimes it also can be more of a burning pain or a tingling pain that resembles the feeling people get when their leg ‘goes to sleep.'”

Rastogi and his colleagues are studying the ability of the investigational drug REN-1654 to help control or eliminate that pain.

The investigational medication is a novel, orally active, small-molecule inhibitor of TNF-alpha, a known proinflammatory cytokine that has been shown to be involved in neuropathology and pain associated with sciatica.

REN-1654 is thought to have promise as a treatment for sciatica because it has been shown to interfere with communication between nerve cell receptors that may carry pain messages.

To be eligible for the study, volunteers must be 18-55 and have leg pain radiating from the lower back to or below the knee that has been diagnosed as pain due to sciatica or to lumbar or lumbosacral radiculopathy.

The onset of pain must have occurred two to 12 weeks prior to the initiation of study treatment.

Those who qualify for the study will receive a daily dose of either the study medication or an inactive placebo for three weeks.

All participants will have their leg and back pain evaluated at one and three weeks after the start of treatment.

Volunteers will then discontinue treatment and remain off medication for three weeks.

At the end of those six weeks, participants will be evaluated again.

Volunteers will receive free study-related physical exams, laboratory tests and investigational study medication. They will also be compensated for time and travel.

The study will require five visits to the Pain Management Center, in the Center for Advanced Medicine.

For more information, call study coordinator Patty Suntrup at 747-1709.