Causalgia of Upper Limb Clinical Trial
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)
| 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 |
| 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 |
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.
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | January 1, 2017 |
| Est. primary completion date | January 1, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Noordwest Ziekenhuisgroep | Alkmaar | North Holland |
| Netherlands | Academic Medical Center | Amsterdam | North Holland |
| Netherlands | Diakonessenhuis | Zeist | Utrecht |
| Lead Sponsor | Collaborator |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Diakonessenhuis, Utrecht |
Netherlands,
| 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 |