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Trial record 10 of 20 for:    Recruiting, Not yet recruiting, Available Studies | Pain | Neurostimulation

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)

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.

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

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : September 2015
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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.)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Comfort of stimulation [ Time Frame: 5 years ]
    Via novel questionnaire patient will validate sensation of paresthesia in different body positions

  2. Quality of life [ Time Frame: 5 years ]
    EuroQol-5D, Short Form-36

  3. Sleep Quality [ Time Frame: 5 years ]
    Using novel Amsterdam Sleep Questionnaire for patients with a neurostimulator

  4. Subject satisfaction [ Time Frame: 5 years ]
    Global Perceived Effect Scale

  5. Pain medication utilization [ Time Frame: 5 years ]
    Medication usage before and after implantation will be registered

  6. Safety [ Time Frame: 5 years ]
    Long term follow up of device related adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553876


Contacts
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Contact: Jennifer Breel, MPA 0205662533 j.s.breel@amc.nl
Contact: Frank Wille, MD 0205662533 f.wille@amc.nl

Locations
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Netherlands
Noordwest Ziekenhuisgroep Recruiting
Alkmaar, North Holland, Netherlands, 1815 JD
Contact: Harmen Pelleboer, MD         
Contact: Stijn de Graaf, MD         
Academic Medical Center Recruiting
Amsterdam, North Holland, Netherlands, 1105 AZ
Contact: Frank Wille, M.D.    +31205669111 ext 64032    f.wille@amc.uva.nl   
Contact: Jennifer S Breel, MPA    +31882505037    j.s.breel@amc.uva.nl   
Principal Investigator: Frank Wille, M.D.         
Principal Investigator: Jennifer S Breel, MPA         
Diakonessenhuis Recruiting
Zeist, Utrecht, Netherlands, 3700 BA
Contact: Frank Wille, M.D.    +31205669111 ext 64032    f.wille@amc.uva.nl   
Contact: Jennifer S Breel, MPA    +31882505037    j.s.breel@amc.uva.nl   
Principal Investigator: Frank Wille, M.D.         
Principal Investigator: Jennifer S Breel, MPA         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Diakonessenhuis, Utrecht
Investigators
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Principal Investigator: Markus W Hollmann, MD, PhD Principal Investigator

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Responsible Party: Jennifer Breel, Research coordinator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02553876     History of Changes
Other Study ID Numbers: AMS-01-2015
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Keywords provided by Jennifer Breel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
neurostimulation
dorsal root ganglion
hand pain
upper limb pain
Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Ganglion Cysts
Synovial Cyst
Causalgia
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neuralgia