Dorsal Root Ganglion Stimulation for Hand and Upper Limb Pain

Terminated

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

• Registration Number: NCT02553876
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Subject satisfaction	5 years	Global Perceived Effect Scale
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
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
Quality of life	5 years	EuroQol-5D, Short Form-36

Trial Locations

Locations (3)

Academic Medical Center; 🇳🇱 Amsterdam, North Holland, Netherlands

Noordwest Ziekenhuisgroep; 🇳🇱 Alkmaar, North Holland, Netherlands

Diakonessenhuis; 🇳🇱 Zeist, Utrecht, Netherlands