The IB-Stim device has been approved to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS), according to the U.S. Food and Drug Administration.
“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a press release.
The prescription-only device has a single-use electrical nerve stimulator that is placed behind the patient’s ear. Stimulating nerve bundles in and around the ear is thought to provide pain relief. The battery-powered chip of the device emits low-frequency electrical pulses continuously for 5 days, at which time it is replaced. Patients can use the device for up to 3 consecutive weeks to reduce functional abdominal pain associated with IBS.
The FDA reviewed data from 50 patients, aged 11-18 years, with IBS; 27 patients were treated with the device and 23 patients received a placebo device. The study measured change from baseline to the end of the third week in worst abdominal pain, usual pain, and Pain Frequency Severity Duration (PFSD) scores. Patients were allowed to continue stable doses of medication to treat chronic abdominal pain.
IB-Stim treatment resulted in at least a 30% decrease in usual pain at the end of 3 weeks in 52% of treated patients, compared with 30% of patients who received the placebo, and at least a 30% decrease in worst pain in 59% of treated patients, compared with 26% of patients who received the placebo.
The treatment group also had greater changes in composite PFSD scores at the end of three weeks. During the study, six patients reported mild ear discomfort, and three patients reported adhesive allergy at the site of application, according to the press release.
The device is contraindicated for patients with hemophilia, patients with cardiac pacemakers, or those diagnosed with psoriasis vulgaris.
The FDA granted marketing authorization of the IB-Stim to Innovative Health Solutions.