ISRCTN10663814.
Study name | Comparison of spinal cord stimulation in combination with standard pain treatment versus standard pain treatment only in patients with intractable chronic back pain without previous history of spine surgery |
Methods | Parallel RCT |
Participants | Chronic low back pain without history of surgery, n = 200 |
Interventions | Differential target multiplexed spinal cord stimulation vs conventional medical management |
Outcomes | Primary: responder rate (>50% improvement in pain), primary endpoint 6 months. Secondary: back pain relief (VAS), Disability (ODI), Quality of life (EQ‐5D, SF‐36), Health Economic Outcomes, Adverse events at 3,6,9,12,18,24 months |
Starting date | 01/01/2020 |
Contact information | Dr Win Laloo, clinical@sgx-international.com |
Notes | Industry sponsored: SGX International LLC |