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

VA Connecticut Healthcare System

Status: Terminated

Conditions: Osteoarthritis

Treatments: Procedure: Ultrasound; Procedure: Sham ultrasound

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01032720

01334

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: All

Ages: 40 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups

Ultrasound-guided knee CS injection

Experimental group

Description:

Ultrasound will be used to image knee joint and guide needle for intra-articular knee CS injection.

Treatment:

Procedure: Ultrasound

Sham Ultrasound knee CS injection

Sham Comparator group

Description:

CS knee injection will be performed in the same method as the US-guided knee injection but the US machine will be turned off.

Treatment:

Procedure: Sham ultrasound