Dorsal Root Ganglion StimulationNCT02553876
Dorsal Root Ganglion Stimulation for Hand and Upper Limb Pain
An observational study of Dorsal Root Ganglion Stimulation and Pain in Limb, Hand, Foot, Fingers and Toes, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dorsal Root Ganglion Stimulation, Pain in Limb, Hand, Foot, Fingers and Toes, Causalgia of Upper Limb
- How many people
- 5 participants
- Where
- 3 sitesNetherlands
- Study dates
- Sep 2015to 1 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Noordwest Ziekenhuisgroep
Alkmaar, North Holland, 1815 JD
Academic Medical Center
Amsterdam, North Holland, 1105 AZ
Diakonessenhuis
Zeist, Utrecht, 3700 BA
About this study
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)
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.
Read the 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.
- Conditions
- Dorsal Root Ganglion Stimulation, Pain in Limb, Hand, Foot, Fingers and Toes, Causalgia of Upper Limb
- Keywords
- neurostimulation, dorsal root ganglion, hand pain, upper limb pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Pain measured on a 10cm Visual Analogue Scale (VAS), where 0 [no pain] and 10 [worst possible pain] imaginable
Measured: 5 years
Secondary outcomes (6)
Comfort of stimulation
Via novel questionnaire patient will validate sensation of paresthesia in different body positions
Measured: 5 years
Quality of life
EuroQol-5D, Short Form-36
Measured: 5 years
Sleep Quality
Using novel Amsterdam Sleep Questionnaire for patients with a neurostimulator
Measured: 5 years
Subject satisfaction
Global Perceived Effect Scale
Measured: 5 years
Pain medication utilization
Medication usage before and after implantation will be registered
Measured: 5 years
Safety
Long term follow up of device related adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Why it stopped: Stopped 1 jan 2017, logistical reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dorsal Root Ganglion StimulationStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Diakonessenhuis, Utrecht
- Responsible party
- Principal investigator, Jennifer Breel, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Markus W Hollmann, MD, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553876
- Sponsor's protocol ID
- AMS-01-2015
- Status last verified
- Nov 2021
- First submitted
- 2 Sep 2015
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02553876
- Acronym / sponsor ID
- AMS-01-2015
- Conditions
- Dorsal Root Ganglion Stimulation, Pain in Limb, Hand, Foot, Fingers and Toes, Causalgia of Upper Limb
- Keywords
- neurostimulation, dorsal root ganglion, hand pain, upper limb pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Stopped 1 jan 2017, logistical reasons
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Diakonessenhuis, Utrecht
- Study start
- Sep 2015 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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.) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Comfort of stimulation
Time frame: 5 years
Quality of life
Time frame: 5 years
Sleep Quality
Time frame: 5 years
Subject satisfaction
Time frame: 5 years
Pain medication utilization
Time frame: 5 years
Safety
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Stopped 1 jan 2017, logistical reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus W Hollmann, MD, PhD principal investigator
Principal Investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dorsal Root Ganglion Stimulation and Pain in Limb, Hand, Foot, Fingers and Toes, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Stopped 1 jan 2017, logistical reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.