Clinical trial NCT02553876: Dorsal Root Ganglion Stimulation for Hand and Upper Limb Pain
Official title: An Observational Cohort Study to Assess the Long Term Effectiveness of Dorsal Root Ganglion Stimulation for Chronic Pain in the Upper Limb(s)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dorsal Root Ganglion Stimulation
Pain in Limb, Hand, Foot, Fingers and Toes
Causalgia of Upper Limb
Keywords: neurostimulation
dorsal root ganglion
hand pain
upper limb pain
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Diakonessenhuis, Utrecht
First posted: 2015-09-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty (20) subjects of either gender, minimum of 18 years of age, maximum of 75 years of age, suffering from chronic, refractory upper limb pain for at least 6 months, who have been or will be routinely scheduled to receive the commercially available DRG Neurostimulator System.

Brief 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.

Detailed description: Dorsal Root Ganglion (DRG) stimulation is a form of Spinal Cord Stimulation (SCS), which has been available and used for the treatment of chronic pain in Europe since late 2011. Clinical practice and pre/post market studies have shown that stimulation of the DRG can significantly reduce chronic intractable pain of various aetiologies. However, there are no studies as yet specifically investigating the application of DRG stimulation in the treatment of chronic pain affecting the upper limbs. Furthermore, there are very few studies of SCS generally, in an upper limb pain population, despite this being a group often referred for and treated with SCS in tertiary, interventional pain practices. Due to several limitations of traditional SCS systems, chiefly concerning the stability of stimulation induced paraesthesia, DRG stimulation is being increasingly utilised in its place for this condition.

Eligibility criteria: * 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

Primary outcomes:
measure: Pain reduction
timeFrame: 5 years
Secondary outcomes:
measure: Comfort of stimulation
timeFrame: 5 years
measure: Quality of life
timeFrame: 5 years
measure: Sleep Quality
timeFrame: 5 years
measure: Subject satisfaction
timeFrame: 5 years
measure: Pain medication utilization
timeFrame: 5 years
measure: Safety
timeFrame: 5 years
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
state: North Holland
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: North Holland
city: Zeist
country: Netherlands
facility: Diakonessenhuis
state: Utrecht
Study officials:
affiliation: Principal Investigator
name: Markus W Hollmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: