NOVEL SPINAL CORD STIMULATOR “ROBUST” IN CHRONIC PAIN

A novel spinal cord stimulator offers a “robust new tool” for treating chronic pain, especially in difficult areas like the back and feet, argue the authors of an Australian trial.

The implant, which stimulates the dorsal root ganglia with electrical charges, more than halved average pain scores in 32 patients with chronic pain that had not responded to drugs or surgery.

More than half of the patients consistently reported pain relief of 50% or better when assessed one week, one month, three months, and six months after implantation.

Average baseline pain scores of 77.6 mm on the visual analog scale dropped to an average of 33.6 mm a month after implantation.

When stimulation was temporarily stopped after five weeks, pain scores rebounded to just below baseline levels, the researchers reported.

Eighty-nine percent of patients with foot pain reported their pain at least halved after implantation, along with 70% of those with leg pain and 57% of those with back pain.

The method “is a robust new tool for the pain physician’s armamentarium”, the researchers wrote in the journal Neuromodulation.

They said it beat traditional dorsal column stimulation by driving paresthesia to areas like the feet that are typically hard to treat.

Because the dorsal root ganglion is encased in the vertebra, there was also less chance of leads migrating, and less chance of stimulation being altered by changes in posture.

Two leads out of 67 migrated (3%), compared to about 13% of percutaneous leads in dorsal column stimulation, the authors said.

The implant demonstrated a “good safety profile” and patients reported better mood and quality of life,” they wrote.

Seventy adverse events were reported in 24 patients, including nine that were serious, such as infection and ataxia. But the authors said only three were possibly related to the implant.

Patients were “certainly aware” of when their device was on, meaning there could have been a placebo effect, the authors conceded.

The study was conducted at four Australian and three European sites. Patients had a minimum baseline pain score of 60 mm and at least six months of chronic pain.

It was funded by manufacturer Spinal Modulation, Inc.

Neuromodulation 2013; online.

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