Clinical trial NCT01032720: Ultrasound (US)-Guided Versus Sham Ultrasound Corticosteroid (CS) Knee Injections
Official title: Ultrasound-guided Versus Sham Ultrasound Corticosteroid Knee Injections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Keywords: ultrasound
osteoarthritis
knee
corticosteroids
intra-articular
injections
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2009-12-15
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if ultrasound-guided knee steroid injections are more effective than sham ultrasound knee steroid injections for the treatment of osteoarthritis.


Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: 4 weeks
Secondary outcomes:
measure: Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing pain as measured by KOOS.
timeFrame: 2, 6, and 8 weeks
measure: Compare the effectiveness of US-guided vs. sham US CS knee injections in improving self-reported lower extremity function.
timeFrame: 2, 4, 6, and 8 weeks
measure: Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing the proportion of patients experiencing knee pain.
timeFrame: 2, 4, 6, and 8 weeks
measure: 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)
timeFrame: 2, 4, 6, and 8 weeks
measure: 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.
timeFrame: 2, 4, 6, and 8 weeks
Other outcomes:
Locations:
city: West Haven
country: United States
facility: West Haven Veteran's Administration Medical Center
state: Connecticut
Study officials:
affiliation: VACHS; Yale University School of Medicine
name: Liana Fraenkel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.