Chronic low back pain (CLBP) is a debilitating condition, especially for patients who are not candidates for spine surgery. For these individuals, effective treatment options have historically been limited. However, groundbreaking research has emerged, highlighting the significant benefits of Differential Target Multiplexed (DTM™) Spinal Cord Stimulation (SCS) over conventional SCS.
Key Study Insights
A U.S.-based randomized controlled trial (RCT) evaluated the long-term efficacy of DTM™ SCS compared to conventional SCS in patients with persistent spinal pain syndrome type 1 (PSPS-T1). This condition is characterized by CLBP associated with degenerative disc disease, herniated discs, or radicular pain, often unresponsive to conservative or surgical interventions.
Study Design
- Participants: Patients with CLBP and leg pain ineligible for spine surgery.
- Methods: A 1:1 randomization between DTM™ SCS and conventional SCS, with a two-way crossover option at six months.
- Primary Endpoint: Achieving at least 50% pain relief at three months.
Results
The study demonstrated the superiority of DTM™ SCS across several measures:
- Pain Relief: Statistically significant higher responder rates for DTM™ SCS at all timepoints (p < 0.0001).
- Patient Satisfaction: 93% of participants reported being satisfied or very satisfied with DTM™ SCS after 12 months.
- Functional Improvement: Patients experienced a notable reduction in disability, with an average decrease of 24 points on the Oswestry Disability Index (ODI)—more than twice the minimal clinically important difference (MCID).
- Crossover Findings: None of the participants switched from DTM™ SCS to conventional SCS. However, nearly half of the conventional SCS group (14 out of 30) opted to cross over to DTM™ SCS, with 92% of them responding positively at follow-up visits.
Implications for CLBP Patients
This research solidifies DTM™ SCS as a highly effective option for managing CLBP in patients not eligible for surgery, offering:
- Enhanced pain relief for both back and leg pain.
- Improved quality of life through reduced disability.
- A new standard of care for neuropathic CLBP management.
Acknowledgments
This pivotal study was sponsored by SGX NOVA (acquired by Medtronic) and involved a collaborative effort from pain management experts across the U.S.
For more information on how DTM™ SCS could benefit your pain management strategy, reach out to our team at Michael Fishman MD.