OsteoarthritisNCT01032720
Ultrasound (US)-Guided Versus Sham Ultrasound Corticosteroid (CS) Knee Injections
A study testing Ultrasound in people with Osteoarthritis, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
To determine if ultrasound-guided knee steroid injections are more effective than sham ultrasound knee steroid injections for the treatment of osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Bilateral total knee replacements.
- Pregnancy if no recent knee x-rays are available.
- Wheelchair bound.
- BMI greater than 40.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Haven Veteran's Administration Medical Center
West Haven, Connecticut, 06516
About this study
Official title: Ultrasound-guided Versus Sham Ultrasound Corticosteroid Knee Injections
To determine if ultrasound-guided knee steroid injections are more effective than sham ultrasound knee steroid injections for the treatment of osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- Ultrasound, Sham ultrasound
- Keywords
- ultrasound, osteoarthritis, knee, corticosteroids, intra-articular, injections
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Also called Sonosite
Ultrasound will be used to image knee joint and guide needle for intra-articular corticosteroid injection.
Sham ultrasoundProcedure or surgery
Also called Sonosite
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided knee CS injection | Experimental | Ultrasound will be used to image knee joint and guide needle for intra-articular knee CS injection. Receives: 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. Receives: Procedure: Sham ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (5)
Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing pain as measured by KOOS.
Measured: 2, 6, and 8 weeks
Compare the effectiveness of US-guided vs. sham US CS knee injections in improving self-reported lower extremity function.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 2, 4, 6, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Liana Fraenkel, M.D., Principal investigator, VACHS; Yale University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032720
- Sponsor's protocol ID
- 01334
- Status last verified
- Feb 2012
- First submitted
- 11 Dec 2009
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12208907Hunt 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.
PubMed 10325667KELLGREN 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.
PubMed 13498604Giltay 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.
PubMed 16505263Roos 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.
PubMed 9699158Roos 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.
PubMed 14613558
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Versus Sham Ultrasound Corticosteroid Knee Injections
- ClinicalTrials.gov ID
- NCT01032720
- Acronym / sponsor ID
- 01334
- Conditions
- Osteoarthritis
- Keywords
- ultrasound, osteoarthritis, knee, corticosteroids, intra-articular, injections
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Jan 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if ultrasound-guided knee steroid injections are more effective than sham ultrasound knee steroid injections for the treatment of osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided knee CS injection | Experimental | Procedure: UltrasoundUltrasound will be used to image knee joint and guide needle for intra-articular knee CS injection. |
| Sham Ultrasound knee CS injection | Sham comparator | Procedure: Sham ultrasoundCS knee injection will be performed in the same method as the US-guided knee injection but the US machine will be turned off. |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundAlso: SonositeUltrasound will be used to image knee joint and guide needle for intra-articular corticosteroid injection. | Procedure or surgery | Ultrasound-guided knee CS injection |
| Sham ultrasoundAlso: SonositeKnee 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. | Procedure or surgery | Sham Ultrasound knee CS injection |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
- Background: PubMed 12208907Jackson 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.
- Background: PubMed 10325667Hunt 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.
- Background: PubMed 13498604KELLGREN 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.
- Background: PubMed 16505263Giltay 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.
- Background: PubMed 9699158Roos 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.
- Background: PubMed 14613558Roos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liana Fraenkel, M.D. principal investigator
VACHS; Yale University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Osteoarthritis, run by VA Connecticut Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032720, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.