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

Primary Purpose

Osteoarthritis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ultrasound

Sham ultrasound

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring ultrasound, osteoarthritis, knee, corticosteroids, intra-articular, injections

Eligibility Criteria

40 Years - 89 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

West Haven Veteran's Administration Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ultrasound-guided knee CS injection

Sham Ultrasound knee CS injection

Arm Description

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

Outcomes

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).

Secondary Outcome Measures

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

Compare the effectiveness of US-guided vs. sham US CS knee injections in improving self-reported lower extremity function.

Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing the proportion of patients experiencing knee pain.

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)

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.

Full Information

NCT ID

NCT01032720

First Posted

December 11, 2009

Last Updated

July 5, 2015

Sponsor

VA Connecticut Healthcare System

1. Study Identification

Unique Protocol Identification Number

NCT01032720

Brief Title

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

Official Title

Ultrasound-guided Versus Sham Ultrasound Corticosteroid Knee Injections

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Terminated

Study Start Date

January 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Connecticut Healthcare System

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

ultrasound, osteoarthritis, knee, corticosteroids, intra-articular, injections

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound-guided knee CS injection

Arm Type

Experimental

Arm Description

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

Arm Title

Sham Ultrasound knee CS injection

Arm Type

Sham Comparator

Arm 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.

Intervention Type

Procedure

Intervention Name(s)

Ultrasound

Other Intervention Name(s)

Sonosite

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Sham ultrasound

Other Intervention Name(s)

Sonosite

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

Time Frame

2, 4, 6, and 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liana Fraenkel, M.D.

Organizational Affiliation

VACHS; Yale University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

West Haven Veteran's Administration Medical Center

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12208907

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.

Results Reference

background

PubMed Identifier

10325667

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.

Results Reference

background

PubMed Identifier

13498604

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.

Results Reference

background

PubMed Identifier

16505263

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.

Results Reference

background

PubMed Identifier

9699158

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.

Results Reference

background

PubMed Identifier

14613558

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.

Results Reference

background

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

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