Ultrasound (US)-Guided Versus Sham Ultrasound Corticosteroid (CS) Knee Injections
NCT ID: NCT01032720
Last Updated: 2015-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
33 participants
INTERVENTIONAL
2010-01-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ultrasound-guided knee CS injection
Ultrasound will be used to image knee joint and guide needle for intra-articular knee CS injection.
Ultrasound
Ultrasound will be used to image knee joint and guide needle for intra-articular corticosteroid injection.
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.
Sham ultrasound
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.
Interventions
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Ultrasound
Ultrasound will be used to image knee joint and guide needle for intra-articular corticosteroid injection.
Sham ultrasound
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
89 Years
ALL
Yes
Sponsors
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VA Connecticut Healthcare System
FED
Responsible Party
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Principal Investigators
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Liana Fraenkel, M.D.
Role: PRINCIPAL_INVESTIGATOR
VACHS; Yale University School of Medicine
Locations
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West Haven Veteran's Administration Medical Center
West Haven, Connecticut, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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01334
Identifier Type: -
Identifier Source: org_study_id
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