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Intraarticular Lumbar Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population

10 oktober 2013 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

28

Fas

  • Tidig fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Florida
      • Gainesville, Florida, Förenta staterna, 32607
        • UF & Shands Orthopaedics and Sports Medicine Institute

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

45 år till 90 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Intra-articular corticosteroid injection
Intra-articular corticosteroid injection in conjunction with confirmatory anesthetic medial branch blocks
Läkemedel: Intra-articular corticosteroid injection
Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint
Placebo-jämförare: Intra-articular saline injection
Intra-articular saline injections with confirmatory anesthetic medial branch blocks
Läkemedel: Intra-articular saline injection
Intra-articular injection of 0.5 cc normal saline in each joint

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction
Tidsram: Hourly for 6 hours post injections
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.
Hourly for 6 hours post injections

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Numeric Pain Rating (NPR) Daily diary
Tidsram: reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
The patient will be instructed to maintain a pain diary that records the degree and duration of any relief.
reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
Oswestry Disability Index (ODI)
Tidsram: 6 weeks, 3 months, 6 months, 12 months
Patient will complete ODI at the follow-up intervals.
6 weeks, 3 months, 6 months, 12 months
Standard Form 36 (SF-36), General Health Survey
Tidsram: 6 weeks, 3 months, 6 months, 12 months
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.
6 weeks, 3 months, 6 months, 12 months
Daily Work History Log
Tidsram: reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up
Patient will keep a Work History Log during participation. The Log should indicate the daily work activities of the subject.
reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up
Daily Analgesic Use Log
Tidsram: reviewed at 6 weeks, 3 months, 6 months, 12 months
Patient will keep a Daily Analgesic Use Log during participation.
reviewed at 6 weeks, 3 months, 6 months, 12 months
Ancillary Treatment Log
Tidsram: reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
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.
reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Florida

Utredare

  • Huvudutredare: D. J. Kennedy, M.D., UF Department of Orthopaedics and Rehabilitation

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2010

Primärt slutförande (Faktisk)

1 september 2012

Avslutad studie (Faktisk)

1 september 2012

Studieregistreringsdatum

Först inskickad

23 juni 2011

Först inskickad som uppfyllde QC-kriterierna

24 juni 2011

Första postat (Uppskatta)

27 juni 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

14 oktober 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 oktober 2013

Senast verifierad

1 oktober 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 319-2010

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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