The principal goal of this study is to compare subjects* experience of Spinal Cord Stimulation (SCS) with two different types of SCS device.
ID
Source
Brief title
Condition
- Other condition
- Spinal cord and nerve root disorders
Synonym
Health condition
Neuropathic lower limb pain
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to compare subject experiences of SCS
with the two different therapies. We have defined 4 separate assessment tools,
which combined, evaluate the primary endpoint of this study:
• Change in perceived stimulation intensity during normal changes in body
posture (Standing/Sitting and Lying)
• Average number of device activations per day
• Assessment (%) of how much of a subject*s painful area is covered by the
stimulation induced paraesthesia
• Assessment (%) of how much of a subjects non-painful area is also covered by
the stimulation induced paraesthesia
Secondary outcome
• Validation of the Paraesthesia Intensity Numerical Rating Scale (PI-NRS)
• Foot / Lower Limb Pain Relief (Visual Analogue Scale)
• Quality of life (EQ-5D-3L)
• Physical functioning (BPI)
• Sleep quality (Bespoke scale created specifically for pain patients treated
with neurostimulation, currently being validated in other on going studies)
• Subject satisfaction (7 Point Likert Scale)
• Device safety by monitoring events according to MEDDEV 2.12-1, rev 8
• Pain medication utilisation (Simple notation of current usage through study
period)
Background summary
Initial clinical studies have shown that stimulation of the dorsal root
ganglion (DRG) can significantly reduce chronic intractable pain. These results
have supported the CE marking of the Spinal Modulation neurostimulator system
(Axium®) in the management of this pain. Subjects* experience of DRG
stimulation therapy, particularly in relation to the precision and stability of
the paraesthesia, appears to be different to that experienced with Dorsal
Column Stimulation (DCS) therapy. Currently, there is no evidence to suggest
that either DCS or DRG stimulation offers superior pain relief to guide a
clinician*s choice of device. Clinical practice and field experience suggests
that unstable and/or diffuse paraesthesia can be limiting factors in the
success of the therapy. To this end, we propose to study the differences of
these aspects of the therapy in order to enable better decision making for
clinicians involved with these treatments in the future.
Study objective
The principal goal of this study is to compare subjects* experience of Spinal
Cord Stimulation (SCS) with two different types of SCS device.
Study design
This is a multi-centre, randomized, pilot study in subjects referred with
chronic intractable uni/bi-lateral neuropathic lower limb pain (below the knee)
with predominant foot pain. Subjects will be randomised to Dorsal Root Ganglion
Stimulation (DRG) or Dorsal Column Stimulation (DCS) in a ratio of 1:1 and
prospectively followed for 1 year.
Intervention
Patients will be randomised to one of the two existing treatments.
Study burden and risks
As both forms of stimulation are accepted forms of neuromodulation in the
Netherlands and both are routinely carried out in the participating centres,
there are no additional risks to the subjects participating in this study.
There is, as yet, no clinical evidence to suggest that the efficacy of one
therapy is superior to the other as a treatment for chronic neuropathic pain.
The collection of follow-up data during routine visits is standard procedure in
all neuromodulation Pain Clinics in the Netherlands. We anticipate that the
added burden of completing the required Case Report Forms (CRF*s) for this
study on the subjects enrolled will equate to an additional 30 minutes per
visit. Visits are scheduled in line with routine follow up visits post SCS
implant\ so there are no additional visits required for the purpose of the
study.
Risk classification based on "kwaliteitsborging mensgebonden onderzoek 2.0"
(from the Dutch Federation of University Medical Centers) is classified as
"negligible risk".
Da Vincilaan 11, F1
Zaventem 1935
BE
Da Vincilaan 11, F1
Zaventem 1935
BE
Listed location countries
Age
Inclusion criteria
1) Subject is appropriate for SCS implantation according to standard criteria from the Dutch Neuromodulation Society
2) Subject is 18 to 75 years old
3) Subject is able and willing to comply with the follow-up schedule and protocol
4) Subject has chronic (> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain
5) Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain
6) Subject is able to provide written informed consent
Exclusion criteria
1) Subject has no other exclusion criteria for SCS implantation according to standard criteria from the Dutch Neuromodulation Society
2) Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
3) Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
4) Subject has participated in another clinical study within 30 days
5) Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02250469 |
| CCMO | NL49661.018.14 |