Ultrasound (US)-Guided Versus Sham Ultrasound Corticosteroid (CS) Knee Injections

Osteoarthritis Clinical Trial

Official title:

Ultrasound-guided Versus Sham Ultrasound Corticosteroid Knee Injections

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01032720
• Other study ID #: 01334
• Status: Terminated
• Phase: N/A
• First received: December 11, 2009
• Last updated: July 5, 2015
• Start date: January 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 89 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	West Haven Veteran's Administration Medical Center	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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-A(9):1522-7. — View Citation

KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		4 weeks	No
Secondary	Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing pain as measured by KOOS.		2, 6, and 8 weeks	No
Secondary	Compare the effectiveness of US-guided vs. sham US CS knee injections in improving self-reported lower extremity function.		2, 4, 6, and 8 weeks	No
Secondary	Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing the proportion of patients experiencing knee pain.		2, 4, 6, and 8 weeks	No
Secondary	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)		2, 4, 6, and 8 weeks	No
Secondary	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.		2, 4, 6, and 8 weeks	No