Clinical Trial: Dorsal Root Ganglion Stimulation for Hand and Upper Limb Pain

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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)

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 chrionic hand or upper limb pain.

Detailed Summary: 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.
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Current Primary Outcome: Pain reduction [ Time Frame: 5 years ]

Pain measured on a 10cm VAS, where 0 [no pain] and 10 [worst possible pain] imaginable


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Comfort of stimulation [ Time Frame: 5 years ]
    Via novel questionnaire patient will validate sensation of paresthesia in different body positions
  • Quality of life [ Time Frame: 5 years ]
    EQ5D, SF-36
  • Sleep Quality [ Time Frame: 5 years ]
    Using novel Amsterdam Sleep Questionnaire for patients with a neurostimulator
  • Subject satisfaction [ Time Frame: 5 years ]
    GPES
  • Pain medication uitlization [ Time Frame: 5 years ]
    Medication usage before and after implantation will be registered
  • Safety [ Time Frame: 5 years ]
    Long term follow up of device related adverse events


Original Secondary Outcome: Same as current

Information By: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Dates:
Date Received: September 2, 2015
Date Started: September 2015
Date Completion: June 2022
Last Updated: September 17, 2015
Last Verified: September 2015