New quality of life and functional improvement data from both the BOLD and TRIUMP studies echo the benefits of the Proclaim XR neurostimulation system (Abbott) for the treatment of chronic pain. Presenting the results at the North American Neuromodulation Society’s (NANS; 23–26 January, Las Vegas, USA) Annual Meeting, Timothy Deer, president and CEO of The Spine and Nerve Center of the Virginias, Charleston, USA, remarked: “BOLD found that BurstDR stimulation reduced the negative psychological effects associated with chronic pain by 62% at the six-month follow-up.”
The BOLD (BurstDR microdosing stimulation in de novo patients) trial is a prospective, multicentre investigation. It utilises patient’s pain catastrophizing scale (PCS) scores in order to determine how pain affects the mental state of a person experiencing chronic pain.
Deer highlighted that 78% of patients had a baseline Oswestry Disability Index (ODI) score of “severe”, “crippling”, or “bed bound”. However, following treatment with the Proclaim XR implant for six months, 71% of patients had “minimal or moderate ODI score”, with 29% having a “severe” or “crippling” ODI score.
In a recent news release, Deer commented on the rationale behind BOLD: “Chronic pain is a broad term that does not accurately capture the variety of issues and symptoms people experience as a result of it.” He added: “Whether the individual is worrying about being bedridden or experiencing severe pain for the rest of their lives, we can share with them the science behind the [Proclaim XR] system to address physical and psychological aspects of pain.”
Further reinforcing these results, additional data were presented at NANS from the TRIUMP study, a prospective, multicentre, single-arm, international study of 269 patients. The trial found significant improvements in physical, mental, and emotional function, which was sustained for up to one-year, post-permanent implant. In addition, patients also reported a reduction in the impact of pain on daily life, which resulted in patients becoming more active when measured at one year.
Commenting on TRIUMP’s findings, Steven M Falowski, Neurosurgical Associates of Lancaster, USA, said: “We now have clinical evidence that Proclaim XR, using the BOLD dosing protocol, shows reductions in two standard measures of characterising pain. The improvements in these two areas are critical factors in creating personalised care plans that help individuals feel better overall and treating the multiple aspects of pain.”