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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Liana Fraenkel, VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT01032720
First received: December 11, 2009
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

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


Condition Intervention
Osteoarthritis
Procedure: Ultrasound
Procedure: Sham ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Versus Sham Ultrasound Corticosteroid Knee Injections

Resource links provided by NLM:


Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • 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). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing pain as measured by KOOS. [ Time Frame: 2, 6, and 8 weeks ] [ Designated as safety issue: No ]
  • Compare the effectiveness of US-guided vs. sham US CS knee injections in improving self-reported lower extremity function. [ Time Frame: 2, 4, 6, and 8 weeks ] [ Designated as safety issue: No ]
  • Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing the proportion of patients experiencing knee pain. [ Time Frame: 2, 4, 6, and 8 weeks ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 2, 4, 6, and 8 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 2, 4, 6, and 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: January 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound-guided knee CS injection
Ultrasound will be used to image knee joint and guide needle for intra-articular knee CS injection.
Procedure: Ultrasound
Ultrasound will be used to image knee joint and guide needle for intra-articular corticosteroid injection.
Other Name: Sonosite
Sham Comparator: 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.
Procedure: 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 Name: Sonosite

  Eligibility

Ages Eligible for Study:   40 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032720

Locations
United States, Connecticut
West Haven Veteran's Administration Medical Center
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Connecticut Healthcare System
Investigators
Principal Investigator: Liana Fraenkel, M.D. VACHS; Yale University School of Medicine
  More Information

Publications:
Responsible Party: Liana Fraenkel, M.D., VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT01032720     History of Changes
Other Study ID Numbers: 01334
Study First Received: December 11, 2009
Last Updated: February 27, 2012
Health Authority: United States: Federal Government

Keywords provided by VA Connecticut Healthcare System:
ultrasound
osteoarthritis
knee
corticosteroids
intra-articular
injections

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014