chronische liespijn chronic post surgical inguinal pain (CPIP) groin pain
Conditions
Interventions
The commercially available Spinal Modulation Axium® SCS System for the
management of chronic intractable pain (CE 567069).
Sponsors
Maxima Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject is at least 18 years old. Subject is able and willing to comply with the follow-up schedule and protocol. Chronic inguinal pain following pfannenstiel incision or inguinal hernia repair or laparoscopic inguinal repair for at least 6 months. Previously undergone neurectomy procedure as a treatment for chronic inguinal pain. Minimum baseline pain rating of 6 out of 10 in the inguinal area on an 11-point NPRS. Subject is able to provide written informed consent. Meets the inclusion criteria for the implantation of a neurostimulation system as set out by the Dutch Neuromodulation Society. Subject has been screened by a multi-disciplanary panel including the designated psychologist of the Máxima Medical Centre Eindhoven and deemed suitable for implantation. Neuropathic Pain as described by a score of *4 on the DN4 questionnaire
Exclusion criteria
Exclusion criteria: Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the trial. Escalating or changing pain condition within the past month as evidenced by investigator examination. Subject has had injection therapy or radiofrequency treatment of a target neural structure within the past 3 months Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump. Subject is unable to operate the device. Subject currently has an active infection. Subject has participated in another clinical investigation within 30 days. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation. Subject has a current or ongoing condition, which will probably require MRI investigation sometime in the following 2 years Subject has had a spinal surgical procedure at or between vertebral levels T10-L2. Subject had been diagnosed with cancer in the past 2 years, except for skin malignancies Subject has a significant progressive peripheral or central neurological disorder such as Diabetic Polyneuropathy or Multiple Sclerosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects with *50% pain relief between the two groups and the difference between groups in the change in numerical pain rating scale (NPRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| * Repeat of primary objective measured at 12 months * As Treated and Number Needed To Treat analysis of Axium group and TNS failures combined at 6 months. * Primary objective analysis as a true Intention to Treat using combined data from the DRG group and TNS trial failures at 6 months * Safety assessed by monitoring occurrence of device related (S)AEs * Quality of life improvements and intergroup comparison between at 6 months (EQ-5D) * Physical functioning improvements and intergroup comparison at 6 months (BPI) * Changes in Sensory Disturbances and intergroup comparison at 6 months (Bedside Quantitative Sensory Testing, QST) * Changes in Neuropathic Pain Scale (NPRS) and intergroup comparisons at 6 months * Subject satisfaction and intergroup comparison at all follow up visits (7 point Likert Scale) * Changes in healthcare resource utilisation and intergroup comparison at 6 months (Health Practitioner Visits/Medication Usage) * Changes in sleep quality and intergroup comparison at 6 months (Daily Sleep Interference Scale) * All above mentioned secondary outcomes will be repeated at 12 months follow-up for the treated group and will be compared to baseline. | — |
Countries
Netherlands
Outcome results
None listed