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 range

22 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Composite Endpoint - Treatment Success

Timeframe: 3 months

Trial details

NCT IDNCT01923285

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-09

Results submitted2018-11-13

View on ClinicalTrials.gov More Chronic Lower Limb Pain trials