Intraarticular Lumbar Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
10 oktober 2013 bijgewerkt door: University of Florida
A Randomized, Double-Blind, Placebo Controlled Perspective Study of Intraarticular Lumbar Zygapophysial Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who have failed conservative therapy including physical therapy, have had an initial >80% pain relief on a diagnostic medial branch block, and are scheduled to undergo a routine second medial branch block for facet mediated pain will be randomized.
Both groups will receive the standard of care, a medial branch block.
The treatment group will also receive one set of intra-articular lumbar Z-joint corticosteroid injection and the placebo group will receive intra-articular normal saline.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, chiropractic treatment, and/or alternative medicine. They will be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and will be schedule for a medial branch block as standard of care. As part of usual and standard care, patients will undergo lumbar medial branch blocks for diagnosis of zygapophysial joint pain.
Patients who obtain ≥ to 80% relief of their index pain with a first set of lumbar medial branch blocks will be offered the opportunity for possible inclusion in the study if they are scheduled to receive a second medial branch block. The definition of a positive response to MBB's is an 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks. If subjects are unable to render NPR scores or percentage estimate of improvement, then a 5 point global perception of effect tool will be used.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
28
Fase
- Vroege fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Florida
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Gainesville, Florida, Verenigde Staten, 32607
- UF & Shands Orthopaedics and Sports Medicine Institute
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
45 jaar tot 90 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Low back pain episode greater than six months in duration
- NPR pain scale score three day average and present pain of at least four/ten at baseline (index pain)
- Previous medial branch block providing >80% pain relief for current painful episode
- Subject must be scheduled to undergo a second medial branch block for their back pain
Exclusion Criteria:
- Litigation
- Those seeking new or increased long-term remuneration
- Leg pain greater than back pain
- Radicular pain or evidence of neurological compromise in the lower limbs
- Those unable to read English and complete the assessment instruments
- Systemic inflammatory arthritis (e.g. rheumatoid, lupus)
- Addictive behavior, severe clinical depression or psychotic features. The subjects will be identified at the sole discretion of the PI who per the current standard of care will consent the potential subjects to the study
- Significant lower extremity pathology that affects gait
- Sustained cervical or thoracic pain that is present at a level >3/10 on NPR
- Possible pregnancy or other reason that precludes the use of fluoroscopy
- Significant scoliosis
- Radicular/neurological deficits or focal disc herniation and/or stenosis, with correlating radicular symptoms
- Contra-indication to corticosteroid, including known allergies or sensitivities
- History of prior epidural spinal injections relieving their current pain, or prior lumbar surgery.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Intra-articular corticosteroid injection
Intra-articular corticosteroid injection in conjunction with confirmatory anesthetic medial branch blocks
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Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint
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Placebo-vergelijker: Intra-articular saline injection
Intra-articular saline injections with confirmatory anesthetic medial branch blocks
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Intra-articular injection of 0.5 cc normal saline in each joint
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction
Tijdsspanne: Hourly for 6 hours post injections
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A positive response is defined as are ≥ 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks.
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Hourly for 6 hours post injections
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Numeric Pain Rating (NPR) Daily diary
Tijdsspanne: reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
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The patient will be instructed to maintain a pain diary that records the degree and duration of any relief.
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reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
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Oswestry Disability Index (ODI)
Tijdsspanne: 6 weeks, 3 months, 6 months, 12 months
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Patient will complete ODI at the follow-up intervals.
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6 weeks, 3 months, 6 months, 12 months
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Standard Form 36 (SF-36), General Health Survey
Tijdsspanne: 6 weeks, 3 months, 6 months, 12 months
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Patient will complete the SF-36 at the follow-up intervals.
The SF-36 is a self-administered, generic, general health survey consisting of 36 questions.
The questions focus on the functional health and well being of the subject completing the form.
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6 weeks, 3 months, 6 months, 12 months
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Daily Work History Log
Tijdsspanne: reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up
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Patient will keep a Work History Log during participation.
The Log should indicate the daily work activities of the subject.
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reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up
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Daily Analgesic Use Log
Tijdsspanne: reviewed at 6 weeks, 3 months, 6 months, 12 months
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Patient will keep a Daily Analgesic Use Log during participation.
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reviewed at 6 weeks, 3 months, 6 months, 12 months
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Ancillary Treatment Log
Tijdsspanne: reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
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Patient will keep an Ancillary Treatment Log during participation.
This log will indicate any outside medical care, additional medial branch blocks or radiofrequency neurotomy treatments.
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reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: D. J. Kennedy, M.D., UF Department of Orthopaedics and Rehabilitation
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2010
Primaire voltooiing (Werkelijk)
1 september 2012
Studie voltooiing (Werkelijk)
1 september 2012
Studieregistratiedata
Eerst ingediend
23 juni 2011
Eerst ingediend dat voldeed aan de QC-criteria
24 juni 2011
Eerst geplaatst (Schatting)
27 juni 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
14 oktober 2013
Laatste update ingediend die voldeed aan QC-criteria
10 oktober 2013
Laatst geverifieerd
1 oktober 2013
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 319-2010
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .