This study will evaluate the effectiveness of DRG neurostimulation for treating chronic groin pain and capture pilot data regarding the mechanisms of DRG neurostimulation.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Chronische onbehandelbare pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Observational study
* To report the number (percentage) of subjects who describe a reduction in
pain intensity of *50% at 6 months post implant as compared to baseline on a
visual analogue scale (VAS) and the average reduction in pain intensity for the
observed cohort.
Optional feasibility study
* To determine subject acceptance of the described QST methodology and
protocol; assessed using a 5 point Likert scale.
* To characterize adverse events due to QST during the study period.
Secondary outcome
Observational study
* Determine presence and duration of analgesic latency using a *stimulation
off* period. Assessed using change in VAS.
* Change in pain interference at 6 months compared to baseline as assessed
using the Brief Pain Inventory (BPI).
* Change in Quality of Life at 6 months compared to baseline as assessed with
the EQ-5D.
* Change in psychological predisposition at 6 months compared to baseline as
assessed with the Profile of Mood States (POMS).
* Subject satisfaction with therapy assessed at 6 months using a two 7-point
Likert scales; the Patient Global Impression of Change (PGIC) and Satisfaction
with Treament Scale (SWTS).
* Device safety assessed by monitoring for device related (S)AE*s and
unanticipated SAE*s.
* To describe the anatomical distribution of stimulation induced paresthesia in
relation to the painful anatomy using subject annotated Pain/Paraesthesia maps
at all follow up points.
Optional Feasibility study
* To determine the practical feasibility of using the described QST methodology
and protocol in the pain clinic setting; assessed by reporting the
investigators ability to work through the full QST protocol in all patients.
* To evaluate the neurophysiological integrity of the nociceptive system in
post surgical groin pain and report any trends towards positive or negative
predictors of successful treatment.
* To report any differences observed in the study cohort at baseline and 6
months post implant and any changes observed.
Background summary
Chronic pain after hernia surgery is a big problem. Conventional pain-reducing
therapies have frequently insufficient effect.
Spinal Cord Stimulation (SCS) provides an opportunity to deal with neuropathic
pain. However, conventional SCS postoperative groin pain could not be
adequately treated. With the advent of a new application of SCS, Dorsal Root
Ganglion Stimulation, this is made possible. To date there have been no
published study results available for that evaluated the application of DRG
stimulation for chronic post-surgical groin pain. In addition, the
neurophysiological stimulation of DRG still largely unknown.
In this study the efficacy of DRG stimulation for chronic post-surgical pain
groin will be examined and also the neurophysiological mechanisms evaluated.
Study objective
This study will evaluate the effectiveness of DRG neurostimulation for treating
chronic groin pain and capture pilot data regarding the mechanisms of DRG
neurostimulation.
Study design
A prospective observational study to assess the effectiveness of the Axium® SCS
system as a treatment for refractory, postsurgical groin pain and a nested
feasibility study to assess the practicality and acceptability of utilising QST
Intervention
Observational study: Switch-off neurostimulator at 3 months
Optional feasibility study: Patients who participate in the sub-study will have
QST assessment
Study burden and risks
There are no additional risks to patients participating in this observational
study as the device is routinely used and patients recruited for this cohort
have already gone through the screening procedure for SCS implantation.
There may be some discomfort experienced during QST testing in the optional
feasibility study but this will be transient.
Airport Plaza - Stockholm Building; Leonardo Da Vincilaan 19
Diegem 1831
BE
Airport Plaza - Stockholm Building; Leonardo Da Vincilaan 19
Diegem 1831
BE
Listed location countries
Age
Inclusion criteria
Inclusion Criteria Observational study
1. Male
2. Age inclusive and between 18 and 65
3. Unilateral post surgical groin pain for 6 months or more
4. Pain localized to the region defined by the anterior superior iliac spine (ASIS), the pubic tubercle, and the groin-gluteal-greater trochanter triangles (3G) point,
5. Pain has no surgical indication
6. Subjects meet the criteria for SCS implantation as set out in the Dutch Neuromodulation Society Guideline (Appendix B)
7. Pain characterized by neuropathy and/or allodynia
8. Average daily baseline pain intensity VAS greater than or equal to 50 mm on a 100mm VAS scale
9. Patient willing and able to give informed consent and to participate in observational study;Additional Inclusion criteria for nested feasibility study
1. Participation in the observational study
2. Sign off for sub-study on patient informed consent
Exclusion criteria
Exclusion Criteria Observational study
1. Inability to speak/read Dutch
2. Bilateral and/or recurrent hernia.
3. Radiofrequency or injection therapy at or close to a target DRG in the 90 days prior to enrolment
4. Current illicit drug use and/or alcohol dependence
5. Active infection, or conditions or indwelling devices that pose an increased risk of infection
6. Active implantable device including implantable cardiac defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
7. Participation in another clinical study during the study period.
8. Any other disorder, condition, or circumstance that, in the opinion of the principal investigator, represents a risk to successful completion of all study activities.;Additional Exclusion criteria for nested feasibility study
1. For sub-study participation only: pain conditions [aside from the post surgical groin pain to be treated], extensive scar tissue, skin conditions, or sensorimotor abnormalities in the areas for QST assessments: the painful groin, the contralateral groin, the ipsilateral arm, and the contralateral hand.
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 |
|---|---|
| CCMO | NL47057.100.14 |