CHRONIC PAIN decision support project enters trial phase

The Pain Unit of the Hospital Ramón y Cajal in Madrid welcomes the first patients for the tests with the EQSA System from which great results are expected.

The CHRONIC PAIN project, financed by the EIT Health programme from the European Union, with a duration of two years and a total budget of almost 1M euros, aims to develop a medical device that will help in the assessment of pain and sensory disorders, specifically aimed at patients suffering from Failed Back Surgery Syndrome (FBSS). On November 4th, the trial of the Electric Quantitative Sensory Assessment (EQSA) system began with the first patients in the Pain Unit of the Ramón y Cajal University Hospital.

In addition to the Madrid Health Service, which is participating through the Ramon y Cajal Hospital Biomedical Research Foundation, the consortium includes Tecnalia, specifically its Neurorehabilitation Unit, and Fesia Technology, a Tecnalia spin-off specialising in functional electrical stimulation. Finally, the Innova area within the Integrated Health Solutions (IHS) unit of Medtronic Ibérica is participating in this project to facilitate the scalability of the EQSA device.

Those patients diagnosed with FBSS experience a persistent chronic pain, normally in the lower back, which often arises after spinal surgery that has been technically and anatomically successful, but which fails to alleviate the patient’s pain due to unknown circumstances. One of the options for treating this condition is through spinal cord stimulation (SCS) therapy, which consists of implanting electrodes at the level of the spinal cord that send a smooth and continuous electrical current to mask the pain signal. Before implantation, patients must undergo a test phase to assess the response to the implant. Patients who experience remarkable pain relief in the trial phase may be candidates for an implantable neurostimulation system. However, since the diagnostic systems currently used are subjective (scales, questionnaires, etc.), there are cases in which patients do not respond well to treatment despite the success of the test phase. Up to 20% of patients do not respond to SCS therapy.

To address this problem, the consortium is developing the EQSA system. The device is a portable multi-field electrode stimulator with an integrated user interface, capable of stimulating different patient nerve fibers with electrical stimuli according to the medical professional’s indications, thus helping them make more accurate decisions about a patient’s eligibility for SCS therapy. In this way, it is expected to reduce the ratio of non-responders to SCS treatment in patients with chronic pain caused by FBSS and to reduce the number of surgical interventions, increasing the value for the patient, with the corresponding saving of economic and hospital resources.

This system will be a breakthrough since it will be able to increase the precision with which clinicians determine which patients are eligible for SCS therapy. The clinical validation and analysis of the results is expected to be completed by the end of August 2021 with a total of 30 patients