NCT01032720

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

July 8, 2015

Status Verified

February 1, 2012

Enrollment Period

2.1 years

First QC Date

December 11, 2009

Last Update Submit

July 5, 2015

Conditions

Osteoarthritis

Keywords

ultrasoundosteoarthritiskneecorticosteroidsintra-articularinjections

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing pain as measured by KOOS.

    2, 6, and 8 weeks

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Ultrasound-guided knee CS injection

EXPERIMENTAL

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

Procedure: Ultrasound

Sham Ultrasound knee CS injection

SHAM COMPARATOR

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

Interventions

UltrasoundPROCEDURE

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

Also known as: Sonosite
Ultrasound-guided knee CS injection
Sham ultrasoundPROCEDURE

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.

Also known as: Sonosite
Sham Ultrasound knee CS injection

Eligibility Criteria

Age40 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Haven Veteran's Administration Medical Center

West Haven, Connecticut, 06516, United States

Location

Related Publications (6)

  • 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.

    PMID: 12208907BACKGROUND

  • 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.

    PMID: 10325667BACKGROUND

  • 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.

    PMID: 13498604BACKGROUND

  • 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.

    PMID: 16505263BACKGROUND

  • 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.

    PMID: 9699158BACKGROUND

  • 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.

    PMID: 14613558BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Liana Fraenkel, M.D.

    VACHS; Yale University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2009

First Posted

December 15, 2009

Study Start

January 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

July 8, 2015

Record last verified: 2012-02

Locations

US(1)