Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads
CompletedNCT01874899
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type, leads experience position-related variation in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.
Study details
- Official title
- Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads
- Conditions
- Chronic Refractory Low Back and Leg Pain
- Interventions
- Device: RestoreSensor Neurostimulation
- Sponsor
- Justin Parker Neurological Institute
- Start date
- 2013-06
- Primary completion
- 2017-12
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Skeletally mature adults between 18 and 70 years old * Patients with chronic refractory back and/or leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions * \> 50% pain reduction during the trail period * Willing and able to comply with the requirements of the protocol including follow-up requirements * Willing to sign a study specific informed consent Exclusion Criteria: * Previous SCS treatment * Surgically remediable spinal condition * Active local or systemic infection
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01874899