Dorsal Root Ganglion Stimulation for Hand and Upper Limb Pain (NCT02553876) | Clinical Trial Compass
TerminatedNot Applicable
Dorsal Root Ganglion Stimulation for Hand and Upper Limb Pain
Stopped: Stopped 1 jan 2017, logistical reasons
Netherlands5 participantsStarted 2015-09
Plain-language summary
There are no studies as yet specifically investigating the application of DRG stimulation in the treatment of chronic pain affecting the upper limbs. The investigators propose to investigate the effect of dorsal root stimulation in patients with chronic hand or upper limb pain.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Subject is appropriate for SCS implantation according to standard criteria from the Dutch Neuromodulation Society
* Subject is \>18 to \<75 years old.
* Subject is able and willing to comply with the follow-up schedule and protocol
* Subject has chronic (\> 6 months) uni/bi-lateral pain, primarily in the upper limb(s)
* (Arm and/or Hand)
* Minimum baseline pain rating of 60 mm on the VAS in the primary region of pain
* Documented, successful paraesthesia mapping of transient stimulation over painful anatomy
* Subject is able to provide written informed consent
Exclusion criteria
* Subject has no other exclusion criteria for SCS implantation according to standard criteria from the Dutch Neuromodulation Society
* Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
* Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
* Subject has participated in another clinical study within 30 days
* Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy
* Subject has had a complete or partial amputation of the painful upper limb(s) and is experiencing phantom and/or stump pain post amputation
What they're measuring
1
Pain reduction
Timeframe: 5 years
Trial details
NCT IDNCT02553876
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)