Knee OsteoarthritisNCT01314820
Effects of Joint Effusion on Quadriceps Muscle
A study testing normal saline injection in people with Knee Osteoarthritis, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The present study investigated whether the presence of fluid in the joint affected peak torque and the root mean square (RMS) values of surface electromyography (EMG) in patients symptomatic for osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- normal saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2009to Jun 2010
- 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 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years old or older with knee osteoarthritis
- knee pain without joint effusion confirmed by ultrasonography
Who cannot join
- the presence of knee joint effusion determined using US
- a history of knee injury or surgery
- a history of knee injection within 3 months
- a history of inflammatory arthritis
- taking anticoagulants
- balance or gait disturbance
- diabetes mellitus
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Seoul, Seoul, 137-701
About this study
Official title: Effects of Joint Effusion on Quadriceps Muscle in Patients With Knee Osteoarthritis
The present study investigated whether the presence of fluid in the joint affected peak torque and the root mean square (RMS) values of surface electromyography (EMG) in patients symptomatic for osteoarthritis (OA).
Read the detailed description
Several studies have shown that knee effusion influenced quadriceps muscle activity and induced quadriceps arthrogenic muscle inhibition in normal volunteers. However, the effect of joint effusion on the quadriceps of patients with OA is controversial,and few patients with OA have been included in studies of joint effusion.
- Conditions
- Knee Osteoarthritis
- Being tested
- normal saline injection, sham injection
- Keywords
- Knee, Osteoarthritis, Effusion.
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal saline injectionOther
Also called normal saline
20 cc normal saline injection into knee joint
sham injectionOther
Also called no normal saline
no saline injection
| Study group | Role | What they receive |
|---|---|---|
| normal saline injection | Active comparator | 20 cc normal saline injection into the knee joint Receives: Other: normal saline injection |
| sham injection | Sham comparator | knee injection without saline Receives: Other: sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the peak torque of the knee extensors
to evaluate the effect of effusion on the peak torque of the knee extensors
Measured: within 5 minutes after intervention
Secondary outcomes (1)
the root mean square values of the vastus medialis and vastus lateralis muscles
to evaluate the effect of effusion on the RMS of the vastus medialis (VM) and vastus lateralis (VL) muscles
Measured: within 5 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJun 2009
- Primary completionJan 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Investigators
- Jongin Lee, M.D, Study director, Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314820
- Sponsor's protocol ID
- KC09OISI0161
- Status last verified
- Jan 2010
- First submitted
- 14 Mar 2011
- Last updated
- 15 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fahrer H, Rentsch HU, Gerber NJ, Beyeler C, Hess CW, Grunig B. Knee effusion and reflex inhibition of the quadriceps. A bar to effective retraining. J Bone Joint Surg Br. 1988 Aug;70(4):635-8. doi: 10.1302/0301-620X.70B4.3403614.
PubMed 3403614Jones DW, Jones DA, Newham DJ. Chronic knee effusion and aspiration: the effect on quadriceps inhibition. Br J Rheumatol. 1987 Oct;26(5):370-4. doi: 10.1093/rheumatology/26.5.370.
PubMed 3664162Rice D, McNair PJ, Dalbeth N. Effects of cryotherapy on arthrogenic muscle inhibition using an experimental model of knee swelling. Arthritis Rheum. 2009 Jan 15;61(1):78-83. doi: 10.1002/art.24168.
PubMed 19116960
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Joint Effusion on Quadriceps Muscle in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01314820
- Acronym / sponsor ID
- KC09OISI0161
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee, Osteoarthritis, Effusion.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Mar 2011 (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.
The present study investigated whether the presence of fluid in the joint affected peak torque and the root mean square (RMS) values of surface electromyography (EMG) in patients symptomatic for osteoarthritis (OA).
Detailed description
Several studies have shown that knee effusion influenced quadriceps muscle activity and induced quadriceps arthrogenic muscle inhibition in normal volunteers. However, the effect of joint effusion on the quadriceps of patients with OA is controversial,and few patients with OA have been included in studies of joint effusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal saline injection | Active comparator | Other: normal saline injection20 cc normal saline injection into the knee joint |
| sham injection | Sham comparator | Other: sham injectionknee injection without saline |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50 years old or older with knee osteoarthritis
- knee pain without joint effusion confirmed by ultrasonography
Key exclusion criteria (7 listed)
- the presence of knee joint effusion determined using US
- a history of knee injury or surgery
- a history of knee injection within 3 months
- a history of inflammatory arthritis
- taking anticoagulants
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 |
|---|---|---|
| normal saline injectionAlso: normal saline20 cc normal saline injection into knee joint | Other | normal saline injection |
| sham injectionAlso: no normal salineno saline injection | Other | sham injection |
Primary outcome
the peak torque of the knee extensors
Time frame: within 5 minutes after intervention
to evaluate the effect of effusion on the peak torque of the knee extensors
1 secondary outcome
the root mean square values of the vastus medialis and vastus lateralis muscles
Time frame: within 5 minutes after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2011.
- Background: PubMed 3403614Fahrer H, Rentsch HU, Gerber NJ, Beyeler C, Hess CW, Grunig B. Knee effusion and reflex inhibition of the quadriceps. A bar to effective retraining. J Bone Joint Surg Br. 1988 Aug;70(4):635-8. doi: 10.1302/0301-620X.70B4.3403614.
- Background: PubMed 3664162Jones DW, Jones DA, Newham DJ. Chronic knee effusion and aspiration: the effect on quadriceps inhibition. Br J Rheumatol. 1987 Oct;26(5):370-4. doi: 10.1093/rheumatology/26.5.370.
- Background: PubMed 19116960Rice D, McNair PJ, Dalbeth N. Effects of cryotherapy on arthrogenic muscle inhibition using an experimental model of knee swelling. Arthritis Rheum. 2009 Jan 15;61(1):78-83. doi: 10.1002/art.24168.
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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.
Jongin Lee, M.D study director
Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal saline injection in people with Knee Osteoarthritis, run by The Catholic University of Korea at 1 site in South Korea.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 15 Mar 2011. 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the peak torque of the knee extensors (time frame: within 5 minutes after intervention). 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 NCT01314820, which also lists 3 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 15 Mar 2011.