Chronic Inguinal Pain Refractory to Previous Surgical Intervention (Neurectomy)
Conditions
Brief summary
24-SMI-2014 is a Randomised Controlled Trial with an optional one way cross-over comparing Conservative Medical Management (CMM) to treatment with the Axium neurostimulator + CMM. Subject population is chronic inguinal pain refractory to previous surgical intervention (neurectomy).
Interventions
Sponsors
Maxima Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is at least 18 years old 2. Subject is able and willing to comply with the follow-up schedule and protocol 3. Chronic inguinal pain following Pfannenstiel Incision or Open Inguinal Hernia Repair for at least 6 months 4. Previously undergone neurectomy procedure as a treatment for chronic inguinal pain 5. Minimum daily average baseline pain rating of 5 out of 10 in the inguinal area on an 11-point NPRS 6. Subject is able to provide written informed consent 7. Meets of the inclusion criteria for the implantation of a neurostimulation system as set out by the Dutch Neuromodulation Society 8. Subject has been screened by a multi-disciplinary panel including the designated psychologist of the Máxima Medical Center and deemed suitable for implantation
Exclusion criteria
1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the Trial 2. Escalating or changing pain condition within the past month as evidenced by investigator examination 3. Subject has had injection therapy or radiofrequency treatment of a target neural structure within the past 3 months 4. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump 5. Subject is unable to operate the device 6. Subjects currently has an active infection 7. Subject has participated in another clinical investigation within 30 days 8. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation 9. Subject has a current or on going condition, which will probably require MRI investigation sometime in the following 2 years 10. Subject has had a spinal surgical procedure at or between vertebral levels T10-L2 11. Subject has been diagnosed with cancer in the past 2 years, except for skin malignancies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects experiencing ≥50% reduction in average daily pain intensity in the Axium Group as compared to the CMM only group using an eleven point (0-10) numerical pain rating scale (NPRS) | 6 months |
Countries
Netherlands
Outcome results
None listed