Chronische onbehandelbare pijn Chronic intractable pain
Conditions
Interventions
Observational study: Switch-off neurostimulator at 3 months
Optional feasibility study: Patients who participate in the sub-study will have
QST assessment
Sponsors
Spinal Modulation NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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: 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed