NL-OMON44602
Completed
Not Applicable
A randomized controlled trial to evaluate the efficacy of the Spinal Modulation Axium neurostimulator therapy as a treatment for persistent inguinal pain following surgical intervention. - SMASHING
Maxima Medisch Centrum0 sites78 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- chronische liespijn
- Sponsor
- Maxima Medisch Centrum
- Enrollment
- 78
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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\.
Outcomes
Primary Outcomes
Not specified
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