Dorsal Root Ganglion Stimulation for Hand and Upper Limb Pain

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

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.

Study Overview

• Status: Terminated
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Netherlands
  • North Holland
    • Alkmaar, North Holland, Netherlands, 1815 JD
      • Noordwest Ziekenhuisgroep
    • Amsterdam, North Holland, Netherlands, 1105 AZ
      • Academic Medical Center
  • Utrecht
    • Zeist, Utrecht, Netherlands, 3700 BA
      • Diakonessenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Diakonessenhuis, Utrecht
• Investigators: Principal Investigator: Markus W Hollmann, MD, PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: September 2, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: neurostimulation; dorsal root ganglion; hand pain; upper limb pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Cysts; Connective Tissue Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Mucinoses; Autonomic Nervous System Diseases; Complex Regional Pain Syndromes; Ganglion Cysts; Synovial Cyst; Causalgia
• Other Study ID Numbers: AMS-01-2015