Dorsal Root Ganglion Stimulation for Hand and Upper Limb Pain

An Observational Cohort Study to Assess the Long Term Effectiveness of Dorsal Root Ganglion Stimulation for Chronic Pain in the Upper Limb(s)

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02553876

Enrollment

Registered

2015-09-18

Start date

2015-09-30

Completion date

2017-01-01

Last updated

2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Causalgia of Upper Limb, Dorsal Root Ganglion Stimulation, Pain in Limb, Hand, Foot, Fingers and Toes

Keywords

neurostimulation, dorsal root ganglion, hand pain, upper limb pain

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Pain reduction	5 years	Pain measured on a 10cm Visual Analogue Scale (VAS), where 0 \[no pain\] and 10 \[worst possible pain\] imaginable

Secondary

Measure	Time frame	Description
Quality of life	5 years	EuroQol-5D, Short Form-36
Sleep Quality	5 years	Using novel Amsterdam Sleep Questionnaire for patients with a neurostimulator
Comfort of stimulation	5 years	Via novel questionnaire patient will validate sensation of paresthesia in different body positions
Pain medication utilization	5 years	Medication usage before and after implantation will be registered
Safety	5 years	Long term follow up of device related adverse events
Subject satisfaction	5 years	Global Perceived Effect Scale

Countries

Netherlands

Outcome results