- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01032720
Ultrasound (US)-Guided Versus Sham Ultrasound Corticosteroid (CS) Knee Injections
5. juli 2015 opdateret af: VA Connecticut Healthcare System
Ultrasound-guided Versus Sham Ultrasound Corticosteroid Knee Injections
To determine if ultrasound-guided knee steroid injections are more effective than sham ultrasound knee steroid injections for the treatment of osteoarthritis.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
33
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Connecticut
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West Haven, Connecticut, Forenede Stater, 06516
- West Haven Veteran's Administration Medical Center
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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
40 år til 89 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age between 40 and 89.
- Meet the American College of Rheumatology criteria for knee OA with knee pain, aching or stiffness on most of the past 30 days and have evidence on radiograph of a definite osteophyte.
- Have a pain score of at least 4 out of 10 on an 11 point numeric rating scale.
- For participants with bilateral knee OA, the most symptomatic knee will be considered the study knee. If both knees are symptomatic, the subject will choose the one they want treated.
- Be able to speak and understand English.
- Have a telephone.
Exclusion Criteria:
- Prior hyaluronic acid injection.
- Scheduled knee hyaluronic acid injections, arthroscopy, or knee surgery.
- Comorbid conditions including: known other causes of arthritis (infectious arthritis, rheumatoid arthritis, connective tissue disease, gout, pseudogout, or psoriatic arthritis), bony or soft tissue malignancy or skin lesions or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limits walking more than knee pain, knee instability defined as report of knee buckling or locking within the past month of the study knee, major neurologic deficit that affects gait, psychiatric illness that limits informed consent
- Current involvement in litigation or receiving workmen's compensation. These patients are to be excluded because they are expected to bias results. This group will be expected to over-report pain symptoms. This bias cannot be corrected for in the analysis.
- Contraindications to intra-articular injections: known bleeding disorder/diathesis.
- Prosthesis in the painful knee.
- Bilateral total knee replacements.
- Pregnancy if no recent knee x-rays are available.
- Wheelchair bound.
- BMI greater than 40.
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Ultrasound-guided knee CS injection
Ultrasound will be used to image knee joint and guide needle for intra-articular knee CS injection.
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Ultrasound will be used to image knee joint and guide needle for intra-articular corticosteroid injection.
Andre navne:
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Sham-komparator: Sham Ultrasound knee CS injection
CS knee injection will be performed in the same method as the US-guided knee injection but the US machine will be turned off.
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Knee CS injection will be performed in the same method as the US-guided injection except that the US machine will be turned off.
Study patient will be unaware of whether US machine is on or off.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Compare the effectiveness of US-guided vs. sham US CS intra-articular knee injections as measured by a 10-point between groups difference in the Knee injury and Osteoarthritis Outcome score (KOOS).
Tidsramme: 4 weeks
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4 weeks
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing pain as measured by KOOS.
Tidsramme: 2, 6, and 8 weeks
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2, 6, and 8 weeks
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Compare the effectiveness of US-guided vs. sham US CS knee injections in improving self-reported lower extremity function.
Tidsramme: 2, 4, 6, and 8 weeks
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2, 4, 6, and 8 weeks
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Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing the proportion of patients experiencing knee pain.
Tidsramme: 2, 4, 6, and 8 weeks
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2, 4, 6, and 8 weeks
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Compare the effectiveness of US-guided vs. sham US knee injections in reducing the use of co-therapies (acetaminophen, nonsteroidal anti-inflammatory drugs, and narcotics)
Tidsramme: 2, 4, 6, and 8 weeks
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2, 4, 6, and 8 weeks
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Examine whether body mass index, presence or absence of chronic widespread pain, radiographic severity, patient expectations, patient satisfaction, and dispositional optimism predict response to CS injections.
Tidsramme: 2, 4, 6, and 8 weeks
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2, 4, 6, and 8 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Liana Fraenkel, M.D., VACHS; Yale University School of Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.
- KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
- Jackson DW, Evans NA, Thomas BM. Accuracy of needle placement into the intra-articular space of the knee. J Bone Joint Surg Am. 2002 Sep;84(9):1522-7. doi: 10.2106/00004623-200209000-00003.
- Hunt IM, Silman AJ, Benjamin S, McBeth J, Macfarlane GJ. The prevalence and associated features of chronic widespread pain in the community using the 'Manchester' definition of chronic widespread pain. Rheumatology (Oxford). 1999 Mar;38(3):275-9. doi: 10.1093/rheumatology/38.3.275.
- Giltay EJ, Kamphuis MH, Kalmijn S, Zitman FG, Kromhout D. Dispositional optimism and the risk of cardiovascular death: the Zutphen Elderly Study. Arch Intern Med. 2006 Feb 27;166(4):431-6. doi: 10.1001/archinte.166.4.431.
- Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
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. januar 2010
Primær færdiggørelse (Faktiske)
1. februar 2012
Studieafslutning (Faktiske)
1. februar 2012
Datoer for studieregistrering
Først indsendt
11. december 2009
Først indsendt, der opfyldte QC-kriterier
14. december 2009
Først opslået (Skøn)
15. december 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. juli 2015
Sidst verificeret
1. februar 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 01334
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .