- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02337699
Dorsal Root Ganglion Stimulation as Treatment for Post-surgical Groin Pain (GASPA)
DORSAL ROOT GANGLION STIMULATION AS TREATMENT FOR POSTSURGICAL GROIN PAIN (GASPA Study)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Nieuwegein, Holland
- St Antonius Ziekenhuis
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Main Study
Inclusion Criteria:
- Male
- Age between >18 and <65 years
- Unilateral post surgical groin pain for >6 months
- 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,
- Pain has no surgical indication
- Subjects meet the criteria for SCS implantation as set out in the Dutch Neuromodulation Society Guideline
- Pain characterized by neuropathy and/or allodynia
- Average daily baseline pain intensity baseline VAS greater than or equal to 50 mm on a 100mm VAS scale
- Patient willing and able to give informed consent and to participate in observational study
Exclusion Criteria:
- Inability to speak/read Dutch
- Bilateral and/or recurrent hernia.
- Radiofrequency or injection therapy at or close to a target DRG in the 90 days prior to enrolment
- Current illicit drug use and/or alcohol dependence
- Active infection, or conditions or indwelling devices that pose an increased risk of infection
- Active implantable device including implantable cardiac defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
- Participation in another clinical study during the study period.
- 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
- Participation in the observational study
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Treated Subjects
All subjects recruited into the main study treated with the Axium neurostimulator
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QST Group
A sub-set of the main study group who also consent to take part in the Quantitative Sensory Testing based feasibility study
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Main Study: Pain Relief - Assessed be Change in Pain Intensity from Pre-Treatment Baseline
Tidsramme: Post implantation at; 1, 3 and 6 months
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Post implantation at; 1, 3 and 6 months
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Feasibility Study: To determine subject acceptance of the described QST methodology and protocol; assessed using a 5 point Likert scale
Tidsramme: Baseline then Post implantation at; 1, 3 and 6 months
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Baseline then Post implantation at; 1, 3 and 6 months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 25-SMI-2014
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