A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chron… (NCT01923285) | Clinical Trial Compass
CompletedNot Applicable
A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain
United States152 participantsStarted 2013-08
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).
Who can participate
Age range22 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subject is male or female between the ages of 22 and 75 years
✓. Subject is able and willing to comply with the follow-up schedule and protocol
✓. Subject has chronic, intractable pain of the lower limb(s) for at least 6 months
✓. Subjects are diagnosed with complex regional pain syndrome (CRPS) and/or peripheral causalgia
✓. Subjects have a minimum Visual Analog Scale (VAS) greater than or equal to 60 mm in the area of greatest pain in the lower limbs.
✓. Subject has failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drugs classes
✓. Subject has had stable neurologic function in the past 30 days
✓. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation of an active implantable medical device
Exclusion criteria
✕. Back pain is the greatest region of pain as measured on the baseline VAS.
✕. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
✕. Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by Investigator examination