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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

28

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Gainesville, Florida, Forenede Stater, 32607
        • UF & Shands Orthopaedics and Sports Medicine Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Numeric Pain Rating (NPR) Daily diary
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Florida

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2010

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. september 2012

Datoer for studieregistrering

Først indsendt

23. juni 2011

Først indsendt, der opfyldte QC-kriterier

24. juni 2011

Først opslået (Skøn)

27. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. oktober 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 319-2010

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