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Dorsal Root Ganglion Stimulation for Hand and Upper Limb Pain

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ClinicalTrials.gov Identifier: NCT02553876
Recruitment Status : Recruiting
First Posted : September 18, 2015
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
Diakonessenhuis, Utrecht
Information provided by (Responsible Party):
Jennifer Breel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Tracking Information
First Submitted Date September 2, 2015
First Posted Date September 18, 2015
Last Update Posted Date June 18, 2018
Study Start Date September 2015
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2018)
Pain reduction [ Time Frame: 5 years ]
Pain measured on a 10cm Visual Analogue Scale (VAS), where 0 [no pain] and 10 [worst possible pain] imaginable
Original Primary Outcome Measures
 (submitted: September 17, 2015)
Pain reduction [ Time Frame: 5 years ]
Pain measured on a 10cm VAS, where 0 [no pain] and 10 [worst possible pain] imaginable
Change History Complete list of historical versions of study NCT02553876 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 15, 2018)
  • 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 ]
    EuroQol-5D, Short Form-36
  • Sleep Quality [ Time Frame: 5 years ]
    Using novel Amsterdam Sleep Questionnaire for patients with a neurostimulator
  • Subject satisfaction [ Time Frame: 5 years ]
    Global Perceived Effect Scale
  • Pain medication utilization [ 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 Measures
 (submitted: September 17, 2015)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Dorsal Root Ganglion Stimulation
  • Pain in Limb, Hand, Foot, Fingers and Toes
  • Causalgia of Upper Limb
Intervention Not Provided
Study Groups/Cohorts Observational
All patients referred with pain in the hand and/or upper limb will be evaluated. Patients will first be assessed for suitability for neurostimulation implantation and then included in the study. Patients wiil fill in questionnaires (pain scores, Quality of Life and satisfaction) at baseline and post-operatively at regular intervals (as per standard of care in the Netherlands.)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 17, 2015)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jennifer Breel, MPA 0205662533 j.s.breel@amc.nl
Contact: Frank Wille, MD 0205662533 f.wille@amc.nl
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02553876
Other Study ID Numbers AMS-01-2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jennifer Breel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators Diakonessenhuis, Utrecht
Investigators
Principal Investigator: Markus W Hollmann, MD, PhD Principal Investigator
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date June 2018