Study Comparing Ultra Low Frequency Spinal Cord Stimulation Plus Standard Care to Standard Care Alone for Treating Chronic Nociceptive Low Back Pain in Adults

What this Trial Is About

Researchers are evaluating whether Ultra Low Frequency ULF neuromodulation can reduce chronic nociceptive low back pain in adults and assessing its safety compared to conventional medical management CMM. This prospective, multi-center, randomized controlled trial focuses on adults with chronic, intractable axial low back pain with prominent nociceptive features, aiming to understand if ULF therapy offers better pain relief and any unexpected medical issues over 24 months. Participants will be randomly assigned in a 21 ratio to either receive ULF therapy combined with CMM or CMM alone. Those in the ULF group will first undergo a temporary trial phase and may receive a permanent implant if they experience at least 50% pain relief. At six months, participants can choose to switch to the other treatment if eligible. The primary outcome, back pain relief measured by a visual analog scale VAS, will be evaluated at three months with continued follow-up for a total of 24 months. During the study, participants will attend regular clinic visits for checkups and data collection. Researchers will assess pain levels, functional improvement, disability, opioid use, and quality of life using various tools including VAS and the Oswestry Disability Index ODI. Safety and treatment effects will be monitored over the entire two-year period to provide comprehensive information about ULF neuromodulation compared to standard care.

Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain