Dorsal Root Ganglion Stimulation for Hand and Upper Limb Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Observational Cohort Study to Assess the Long Term Effectiveness of Dorsal Root Ganglion Stimulation for Chronic Pain in the Upper Limb(s)

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>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.) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | Pain measured on a 10cm Visual Analogue Scale (VAS), where 0 [no pain] and 10 [worst possible pain] imaginable | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort of stimulation | Via novel questionnaire patient will validate sensation of paresthesia in different body positions | 5 years | 
| Quality of life | EuroQol-5D, Short Form-36 | 5 years | 
| Sleep Quality | Using novel Amsterdam Sleep Questionnaire for patients with a neurostimulator | 5 years | 
| Subject satisfaction | Global Perceived Effect Scale | 5 years | 
| Pain medication utilization | Medication usage before and after implantation will be registered | 5 years | 
| Safety | Long term follow up of device related adverse events | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurostimulation, dorsal root ganglion, hand pain, upper limb pain