Clinical trial NCT02337699: Dorsal Root Ganglion Stimulation as Treatment for Post-surgical Groin Pain
Official title: DORSAL ROOT GANGLION STIMULATION AS TREATMENT FOR POSTSURGICAL GROIN PAIN (GASPA Study)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Post Surgical Groin Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-01-14
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Post Surgical Groin Pain Patients

Brief summary: 25-SMI-2014 is a post market observational, questionnaire based study to assess the effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin pain. Within is also a nested feasibility study to assess the clinical utility of a Quantitive Sensory Testing (QST) protocol in the management of the described study group.


Eligibility criteria: Main Study

Inclusion Criteria:

1. Male
2. Age between \>18 and \<65 years
3. Unilateral post surgical groin pain for \>6 months
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
7. Pain characterized by neuropathy and/or allodynia
8. Average daily baseline pain intensity baseline 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

Exclusion Criteria:

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 Criteria for nested feasibility study

Additional Inclusion Criteria

1. Participation in the observational study
2. Sign off for sub-study on patient informed consent

Additional Exclusion Criteria

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

Primary outcomes:
measure: Main Study: Pain Relief - Assessed be Change in Pain Intensity from Pre-Treatment Baseline
timeFrame: Post implantation at; 1, 3 and 6 months
measure: Feasibility Study: To determine subject acceptance of the described QST methodology and protocol; assessed using a 5 point Likert scale
timeFrame: Baseline then Post implantation at; 1, 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
Study officials:
References: