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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02553876
Other study ID # AMS-01-2015
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 2015
Est. completion date January 1, 2017

Study information

Verified date November 2021
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Noordwest Ziekenhuisgroep Alkmaar North Holland
Netherlands Academic Medical Center Amsterdam North Holland
Netherlands Diakonessenhuis Zeist Utrecht

Sponsors (2)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Diakonessenhuis, Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain reduction Pain measured on a 10cm Visual Analogue Scale (VAS), where 0 [no pain] and 10 [worst possible pain] imaginable 5 years
Secondary Comfort of stimulation Via novel questionnaire patient will validate sensation of paresthesia in different body positions 5 years
Secondary Quality of life EuroQol-5D, Short Form-36 5 years
Secondary Sleep Quality Using novel Amsterdam Sleep Questionnaire for patients with a neurostimulator 5 years
Secondary Subject satisfaction Global Perceived Effect Scale 5 years
Secondary Pain medication utilization Medication usage before and after implantation will be registered 5 years
Secondary Safety Long term follow up of device related adverse events 5 years