Dorsal Root Ganglion Stimulation for Hand and Upper Limb... | NCT02553876

Studies
Dorsal Root Ganglion Stimulation for Hand and Upper Limb Pain

NCT02553876

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Terminated

Last Update Posted

Dec 14, 2021Actual

Enrollment

5Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Stopped 1 jan 2017, logistical reasons

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Jan 1, 2017Actual

Completion Date

Jan 1, 2017Actual

First Submitted Date

Sep 2, 2015

First Submission Date that Met QC Criteria

Sep 17, 2015

First Posted Date

Sep 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2021

Last Update Posted Date

Dec 14, 2021Actual

Name	Class
Diakonessenhuis, Utrecht	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.)

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Noordwest Ziekenhuisgroep		Alkmaar	North Holland	1815 JD	Netherlands
Academic Medical Center