Abbott declared the first patient has been enrolled in the DISTINCT study (Dorsal spInal cord STImulatioN vs mediCal management for the Treatment of low back pain). The clinical trial will assess the company’s BurstDRTM spinal cord stimulation (SCS) efficiency compared with conventional medical management (CMM) in patients with chronic low back pain that cannot be treated with routine medical therapy.
Abbott’s BurstDRTM spinal cord stimulation (SCS) vs conventional medical management (CMM)
The study will investigate the level of pain management effectiveness, the stage of the physical function capacity and the emotional well-being in people living with chronic low back pain, who have not undergone lumbar spine surgery or for whom surgery is not indicated. DISTINCT is a prospective, multi-center, randomized, monitored clinical trial designed to assess the effectiveness of Abbott’s BurstDR SCS in the treatment of chronic low back pain with a neuropathic (unrelenting, extreme and persistent pain) aspect, compared to the standard medical treatment using the medicine and other conventional non-surgical approaches to treat the pain of the patient.
SCS treatment to assess chronic low back pain relief
The DISTINCT study’s primary and secondary endpoints intend to capture the participant’s physical capacity adjustment and low back pain relief progress. Additional endpoints may be used to determine indicators of quality of life, including depression, sleep, emotional distress, use of additional pain killers and the participant’s general comfort and satisfaction with the treatment.
Keith Boettiger, Vice President, Neuromodulation, at Abbott said:
“The DISTINCT study will provide important data in our clinical development program for intermittently dosed BurstDR stimulation. Conducting this study is another example of how Abbott is listening to patients, physicians and the pain community to address current unmet needs in pain management. For the patients, we see this as a unique opportunity to address their suffering as well as their pain.”
The DISTINCT study will enroll 270 participants in up to 30 federal states. Furthermore, the participants will be randomized for SCS treatment and CMM, respectively. After the six months study in either arm, all participants will be given a choice to cross over – providing a chance for those in the medical management arm of the study to opt for BurstDR stimulation in the open label part of the study.
About Abbott’s Chronic Pain Portfolio
Chronic pain can adversely affect personal relationships, the effectiveness of work and the everyday life of an individual. In the portfolio of chronic pain therapies, Abbott is a world pioneer in the development of chronic pain management therapies, providing radiofrequency and spinal cord stimulation therapy solutions, including BurstDR stimulation and dorsal root ganglion stimulation.
Abbott is a world healthcare leader and a global pioneer in healthcare that lets individuals at all levels of life, live more fully. The companies portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Abbott has 107,000 employees serving people in more than 160 countries around the world.
For more information please go to: www.abbott.com