Evaluatie van de werkzaamheid en veiligheid van multi-tined expandable electrode (MEE) bij de behandeling van lumbale facetartropathie door radiofrequente neurotomieën in vergelijking met conservatieve medische behandeling. (MEE)
The purpose of this study is to better understand how people feel after a radiofrequency ablation standard of care surgery using a different type of needle (multi-tined expandable electrode/MEE) in comparison to receiving conventional medical management (CMM) techniques.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Angie Ballew, DC, MS
- Telefoonnummer: (913) 945-7420
- E-mail: aballew@kumc.edu
Studie Locaties
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Kansas
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Kansas City, Kansas, Verenigde Staten, 66160
- Werving
- University of Kansas Medical Center
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Contact:
- Principal Investigator
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Age > 18 years old.
- Patients with pain lasting at least 6 months.
- Patients with history of non-radiating low back pain.
- Patient who had two diagnostic medial branch blocks (MBB) with significant (>50%) improvement on both injections.
- Patient has signed study-specific informed consent.
- Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.
Exclusion Criteria:
- Patient with low back pain with radiation or involvement of pain going into their legs below their knees.
- Patient did not receive satisfactory relief from diagnostic MBB (<50% relief).
- Patient is unable to receive radiation exposure.
- Patient is currently pregnant.
- Patient has a current local overlying low back or systemic infection.
- Patient currently receiving or seeking workers compensation, disability remuneration, and/or involved in injury litigation.
- Known or suspected drug or alcohol abuse.
- Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
- Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation.
- Patient has an implanted intrathecal pump or spinal neuromodulation device.
- Patient currently on daily oral morphine equivalent (OME) of 50.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Radiofrequency ablation (RFA) with MEE
Radiofrequency ablation involves a minimally invasive procedural technique. It uses radiofrequency waves to burn the nerve causing pain. This nerve will no longer be able to send pain signals to your brain. For this study, the multi-tined expandable electrode needle will be used. This needle will result in a larger treatment area. This may result in better pain relief and longer lasting pain relief. If you undergo the radiofrequency ablation procedure you will have pain medication injected where the ablation will be done. The procedure will take about 20 mins to complete. You will be allowed to go home afterward. |
RFA will be performed in the usual fashion utilizing the MEE instead of the RFA needles routinely used at each institution. |
|
Actieve vergelijker: Conventional Medical Management (CMM) Treatment Only
Your current standard of care treatment may already consist of some CMM therapies. Standard of care includes a variety of intervention types such as medication, physical therapy, home exercise programs, back brace, walking aid, and chiropractic care. |
Conventional medical management (CMM), which may include physical therapy, home exercise programs, pain medication, and other conservative therapies such as back brace, walking aid, and chiropractic care. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The mean visual analog scale (VAS) between the two group
Tijdsspanne: 12 months
|
will be compared using an independent samples t-test |
12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Observe the incidence of complications associated with MEE while utilizing this device
Tijdsspanne: 12 months
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Number of complications will be analyzed using Independent samples T-Test if there is a normal distribution of complications. In the event of a binary outcome for complications, Chi-square Test will be used. |
12 months
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Dawood Sayed, MD, University of Kansas Medical Center
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STUDY00146448
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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