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GASPA: Dorsal Root Ganglion Stimulation as Treatment for Post-surgical Groin Pain

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Terminated
CT.gov ID
NCT02337699
Collaborator
(none)
1
Enrollment
1
Location
8
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Implantation with the commercially available Axium neurostimulator
  • Procedure: QST Testing

Study Design

Study Type:
Observational
Actual Enrollment :
1 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
DORSAL ROOT GANGLION STIMULATION AS TREATMENT FOR POSTSURGICAL GROIN PAIN (GASPA Study)
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Treated Subjects

All subjects recruited into the main study treated with the Axium neurostimulator

Device: Implantation with the commercially available Axium neurostimulator
QST Group

A sub-set of the main study group who also consent to take part in the Quantitative Sensory Testing based feasibility study

Device: Implantation with the commercially available Axium neurostimulator

Procedure: QST Testing

Outcome Measures

Primary Outcome Measures

  1. Main Study: Pain Relief - Assessed be Change in Pain Intensity from Pre-Treatment Baseline [Post implantation at; 1, 3 and 6 months]

  2. Feasibility Study: To determine subject acceptance of the described QST methodology and protocol; assessed using a 5 point Likert scale [Baseline then Post implantation at; 1, 3 and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 18 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St Antonius Ziekenhuis Nieuwegein Netherlands

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT02337699
Other Study ID Numbers:
  • 25-SMI-2014
First Posted:
Jan 14, 2015
Last Update Posted:
Feb 4, 2019
Last Verified:
Jan 1, 2019
Additional relevant MeSH terms:
Ganglion Cysts

Study Results

No Results Posted as of Feb 4, 2019