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

Post Surgical Groin Pain Clinical Trial

— GASPA  

Official title:

DORSAL ROOT GANGLION STIMULATION AS TREATMENT FOR POSTSURGICAL GROIN PAIN (GASPA Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02337699
• Other study ID #: 25-SMI-2014
• Status: Terminated
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Surgical Groin Pain

Intervention

Device:
• Implantation with the commercially available Axium neurostimulator

Procedure:
• QST Testing

Locations

Country	Name	City	State
Netherlands	St Antonius Ziekenhuis	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main Study: Pain Relief - Assessed be Change in Pain Intensity from Pre-Treatment Baseline		Post implantation at; 1, 3 and 6 months
Primary	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