Effusion JointNCT04146649
Effect of Therapeutic Joint Arthrocentesis on Pain and Quadriceps Function in Patients With Knee Osteoarthritis
A study testing Arthrocentesis in people with Effusion Joint, run by Colorado Joint Replacement at 2 sites in United States.
Trial summary
This will be prospective study of patients with knee effusion associated with degenerative osteoarthritis or symptomatic primary total knee arthroplasty that undergo therapeutic joint arthrocentesis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Effusion Joint
- What is being tested?
- Arthrocentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Dec 2019to 10 Apr 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older with mild (1+) to severe (3+) knee effusion associated with underlying osteoarthritis (Kellgren and Lawrence grade II or higher) that undergo therapeutic aspiration
- Patients with symptomatic primary total knee arthroplasty without infection (as verified by prior aspiration) with moderate to severe effusion electing for therapeutic arthrocentesis. Must be minimum of 3 months from index surgery to be included.
Who cannot join
- Patients with effusion related to trauma or another underlying condition (ie. fracture, ligamentous injury, hemarthrosis)
- Patients with known history of gout or with synovial fluid samples testing positive for urate of calcium pyrophosphate crystals
- Patients with knee effusion associated with septic arthritis or periprosthetic knee infection as determined from knee arthrocentesis.
- Patients with inflammatory arthritis (ie. JIA, RA, psoriatic arthritis, etc).
- Patients with revision knee arthroplasty, unicompartmental arthroplasty or other repair/reconstruction surgery
- Patients with underlying muscular disorder (ie. Stroke, cerebral palsy, multiple sclerosis, polymyalgia, fibromyalgia, muscular dystrophy, etc.)
Show all 12Show fewer
- Patients with symptomatic hip pain
- Patients with active cancer in the area
- Patients with pacemakers
- Patients who are pregnant
- Invasive or injectable therapy within the last 6 months in the involved knee, to include, but not limited to, arthrocentesis, corticosteroid, hyaluronic acid, platelet-rich plasma, prolotherapy, stem cell therapy, or genicular nerve block.
- Blood clotting disorders, sickle cell disease or trait, or chronic anticoagulation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver
Aurora, Colorado, 80045
Colorado Joint Replacement
Denver, Colorado, 80210
About this study
This will be prospective study of patients with knee effusion associated with degenerative osteoarthritis or symptomatic primary total knee arthroplasty that undergo therapeutic joint arthrocentesis. The diagnosis of knee osteoarthritis will be based on knee radiographs (including AP, Rosenburg view, lateral and Merchant views) read and interpreted by one of our clinical providers (PA, Fellow or Surgeon). Patients with at least Grade II Kellgren and Lawrence changes or higher will be included in the osteoarthritis group. Patients in the arthroplasty group must have had a primary total knee arthroplasty without infection (as determined by knee aspirate) to be included. Patients will be clinically evaluated at the time of their visit for presence of a knee effusion using a stroke test and graded on a 5-point scale (zero, trace, 1+, 2+, or 3+) which has shown good interrater reliability. Patients with a mild to severe effusion (1+ to 3+) will considered for the study. Patients having significant pain associated with their effusion will be offered a therapeutic arthrocentesis as part of their treatment plan discussion. This is a pre-post test design in which outcome measures will be collected immediately pre-arthrocentesis and immediately post arthrocentesis. Additionally, there will be an optional 7-10 follow up visit where outcomes measures will be collected again, should the participant choose to return to this visit.
Read the detailed description
Pain and Self-Reported Function
Knee pain will be assessed with an 11-point numeric pain rating scale (NPRS) where 0 represents 'no pain' and 10 represents 'worst imaginable pain'. Self-reported physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for each knee separately. The WOMAC assesses the impact of knee osteoarthritis on multiple domains-pain, stiffness, and disability. A composite score (0-100 scale) will be used for analysis.
Range of Motion
Knee range of motion (ROM) is a direct measure of joint mobility following TKA. Knee ROM will be measured in the supine position both actively and passively using a long-arm goniometer. Goniometry has been shown to be a reliable measure of knee ROM after TKA.
Quadriceps Strength and Activation Testing
Maximum voluntary isometric quadriceps strength and quadriceps activation will be assessed before surgery and at week 3 using an electromechanical dynamometer (Humac Norm, CSMI) and a doublet interpolation test. Patients will be seated on the electromechanical dynamometer with their hips flexed to approximately 85° and their knees flexed to 60°. Two 3" by 5" self-adhesive neuromuscular stimulation electrodes will be placed over the motor points of the rectus femoris and the vastus medialis. A Grass S48 stimulator with a Grass Model SIU8T stimulus isolation unit will be used to deliver 600 µs doublet pulses. A Biopac MP150WSW system will be used for data acquisition during testing with sampling frequency of 300 Hz.
Following two warm-up contractions, a practice maximal voluntary isometric contraction (MVIC) will be performed against the dynamometer's force transducer. Visual torque targets will be set on the feedback monitor at slightly higher torques than produced during the practice MVIC trial. Trials will be repeated until maximal torque is within 5% of the previous attempt. Torque from quadriceps MVIC will be normalized to body weight for between-subject comparisons.
Voluntary activation of the quadriceps muscle will be assessed using the doublet interpolation technique, where a supramaximal stimulus will be applied by a Grass S48 stimulator during an MVIC and immediately afterwards while the quadriceps muscle is at
rest. Normalization of the force from the superimposed doublet to the resting doublet allows for comparisons of quadriceps activation across individuals and lower extremities.
Timed-Up-and-Go
The timed-up-and-go (TUG) test is a responsive, valid, and reliable functional measure of basic mobility and dynamic balance. The examiner measures the time, in seconds, required by the patient to a) rise from an arm chair; b) walk 3 meters; c) turn and walk back to the arm chair; and d) return to the seated position.
30-second Sit-to-Stand Test
The 30-second Sit-to-Stand test (30STS) is a responsive, valid, and reliable functional measure of lower extremity strength after TKA. This test counts the number of times a patient can rise to a full standing position in 30 seconds. The test starting position is sitting on an armless chair with seat plate 17 inches from the floor. Patients rise from this position with hands placed on opposite shoulders. If the patient must use his/her arms to stand, the test is stopped. If the patient is over halfway to a standing position when 30 seconds have lapsed, this counts as a stand.
Bioimpedance Spectroscopy
Bioimpedance spectroscopy (BIS) is a reliable, responsive measure of swelling that has been validated in observational studies of individuals after TKA. The RJL Systems Quantum® (Clinton Township, MI) bioelectrical impedance device delivers a 2.5 µA alternating current at a frequency of 50 kHz. The tissue impedance to this current is displayed in Ohms (Ω) and is recorded at a precision of 1 Ω. The level of impedance met by the current reflects the composition of the tissue, but will also fluctuate with the presence of swelling in the lower extremity. Lower levels of impedance represent the increased fluid content present with greater levels of swelling. Measuring the impedance of both the involved and uninvolved limb allows for calculation of a ratio (W-involved limb: W-uninvolved limb). To measure impedance, a four-wire measurement method will be used. The most proximal electrode pair will be placed 10 and 20 centimeters above the superior patellar pole. The most distal electrode pair will be placed at a point bisecting the medial and lateral malleolus, and also 10 cm distal to that point along the second ray of the foot. New electrodes will be used for each testing session, and skin will be cleaned with an alcohol swab prior to electrode placement.
- Conditions
- Effusion Joint
- Being tested
- Arthrocentesis
- Medical subject headings
- Hydrarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthrocentesisProcedure or surgery
Patients will receive a joint arthrocentesis to remove fluid from the joint.
| Study group | Role | What they receive |
|---|---|---|
| Primary Osteoarthritis | Experimental | Patients with native knees and effusions will participate in this arm. Receives: Procedure: Arthrocentesis |
| Primary TKA | Experimental | Patients with total knee replacements will participate in this arm. Receives: Procedure: Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quadriceps activation
The change in quadriceps activation prior to and post arthrocentesis will be measured.
Measured: Immediately pre aspiration (day 0), immediately post aspiration (day 0),optional 7-10 days post aspiration
Secondary outcomes (7)
Change in Pain
Self reported pain scores
Measured: Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Function
Self reported function will be collected
Measured: Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Range of Motion
Range of motion will be measured
Measured: Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Quadriceps Strength
This will be measured using the Humac Norm chair
Measured: Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Functional Performance
This will be assessed with standardized functional tests (30 STS, TUG)
Measured: Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Volume of Knee Synovial Fluid Aspirated
We will look at the volume of fluid drawn off the knee
Measured: Immediately post aspiration (day 0)
Bioelectrical Impedance
This will be measured with The RJL Systems Quantum®
Measured: Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start5 Dec 2019
- Primary completion31 Aug 2022
- Study completion10 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Effusion JointStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado Joint Replacement
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Jennings, Colorado Joint Replacement
- Investigators
- Jason Jennings, MD, Principal investigator, Colorado Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146649
- Sponsor's protocol ID
- 1415301
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2019
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
PubMed 18163497Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6.
PubMed 19407734Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1145-53. doi: 10.1016/j.joca.2013.03.018.
PubMed 23973124Dieppe PA, Lohmander LS. Pathogenesis and management of pain in osteoarthritis. Lancet. 2005 Mar 12-18;365(9463):965-73. doi: 10.1016/S0140-6736(05)71086-2.
PubMed 15766999Egloff C, Hugle T, Valderrabano V. Biomechanics and pathomechanisms of osteoarthritis. Swiss Med Wkly. 2012 Jul 19;142:w13583. doi: 10.4414/smw.2012.13583. eCollection 2012.
PubMed 22815119
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Therapeutic Joint Arthrocentesis on Pain and Quadriceps Function in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04146649
- Acronym / sponsor ID
- 1415301
- Conditions
- Effusion Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Colorado Joint ReplacementUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 31 Oct 2019 (actual)
- 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.
This will be prospective study of patients with knee effusion associated with degenerative osteoarthritis or symptomatic primary total knee arthroplasty that undergo therapeutic joint arthrocentesis. The diagnosis of knee osteoarthritis will be based on knee radiographs (including AP, Rosenburg view, lateral and Merchant views) read and interpreted by one of our clinical providers (PA, Fellow or Surgeon). Patients with at least Grade II Kellgren and Lawrence changes or higher will be included in the osteoarthritis group. Patients in the arthroplasty group must have had a primary total knee arthroplasty without infection (as determined by knee aspirate) to be included. Patients will be clinically evaluated at the time of their visit for presence of a knee effusion using a stroke test and graded on a 5-point scale (zero, trace, 1+, 2+, or 3+) which has shown good interrater reliability. Patients with a mild to severe effusion (1+ to 3+) will considered for the study. Patients having significant pain associated with their effusion will be offered a therapeutic arthrocentesis as part of their treatment plan discussion. This is a pre-post test design in which outcome measures will be collected immediately pre-arthrocentesis and immediately post arthrocentesis. Additionally, there will be an optional 7-10 follow up visit where outcomes measures will be collected again, should the participant choose to return to this visit.
Detailed description
Pain and Self-Reported Function
Knee pain will be assessed with an 11-point numeric pain rating scale (NPRS) where 0 represents 'no pain' and 10 represents 'worst imaginable pain'. Self-reported physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for each knee separately. The WOMAC assesses the impact of knee osteoarthritis on multiple domains-pain, stiffness, and disability. A composite score (0-100 scale) will be used for analysis.
Range of Motion
Knee range of motion (ROM) is a direct measure of joint mobility following TKA. Knee ROM will be measured in the supine position both actively and passively using a long-arm goniometer. Goniometry has been shown to be a reliable measure of knee ROM after TKA.
Quadriceps Strength and Activation Testing
Maximum voluntary isometric quadriceps strength and quadriceps activation will be assessed before surgery and at week 3 using an electromechanical dynamometer (Humac Norm, CSMI) and a doublet interpolation test. Patients will be seated on the electromechanical dynamometer with their hips flexed to approximately 85° and their knees flexed to 60°. Two 3" by 5" self-adhesive neuromuscular stimulation electrodes will be placed over the motor points of the rectus femoris and the vastus medialis. A Grass S48 stimulator with a Grass Model SIU8T stimulus isolation unit will be used to deliver 600 µs doublet pulses. A Biopac MP150WSW system will be used for data acquisition during testing with sampling frequency of 300 Hz.
Following two warm-up contractions, a practice maximal voluntary isometric contraction (MVIC) will be performed against the dynamometer's force transducer. Visual torque targets will be set on the feedback monitor at slightly higher torques than produced during the practice MVIC trial. Trials will be repeated until maximal torque is within 5% of the previous attempt. Torque from quadriceps MVIC will be normalized to body weight for between-subject comparisons.
Voluntary activation of the quadriceps muscle will be assessed using the doublet interpolation technique, where a supramaximal stimulus will be applied by a Grass S48 stimulator during an MVIC and immediately afterwards while the quadriceps muscle is at
rest. Normalization of the force from the superimposed doublet to the resting doublet allows for comparisons of quadriceps activation across individuals and lower extremities.
Timed-Up-and-Go
The timed-up-and-go (TUG) test is a responsive, valid, and reliable functional measure of basic mobility and dynamic balance. The examiner measures the time, in seconds, required by the patient to a) rise from an arm chair; b) walk 3 meters; c) turn and walk back to the arm chair; and d) return to the seated position.
30-second Sit-to-Stand Test
The 30-second Sit-to-Stand test (30STS) is a responsive, valid, and reliable functional measure of lower extremity strength after TKA. This test counts the number of times a patient can rise to a full standing position in 30 seconds. The test starting position is sitting on an armless chair with seat plate 17 inches from the floor. Patients rise from this position with hands placed on opposite shoulders. If the patient must use his/her arms to stand, the test is stopped. If the patient is over halfway to a standing position when 30 seconds have lapsed, this counts as a stand.
Bioimpedance Spectroscopy
Bioimpedance spectroscopy (BIS) is a reliable, responsive measure of swelling that has been validated in observational studies of individuals after TKA. The RJL Systems Quantum® (Clinton Township, MI) bioelectrical impedance device delivers a 2.5 µA alternating current at a frequency of 50 kHz. The tissue impedance to this current is displayed in Ohms (Ω) and is recorded at a precision of 1 Ω. The level of impedance met by the current reflects the composition of the tissue, but will also fluctuate with the presence of swelling in the lower extremity. Lower levels of impedance represent the increased fluid content present with greater levels of swelling. Measuring the impedance of both the involved and uninvolved limb allows for calculation of a ratio (W-involved limb: W-uninvolved limb). To measure impedance, a four-wire measurement method will be used. The most proximal electrode pair will be placed 10 and 20 centimeters above the superior patellar pole. The most distal electrode pair will be placed at a point bisecting the medial and lateral malleolus, and also 10 cm distal to that point along the second ray of the foot. New electrodes will be used for each testing session, and skin will be cleaned with an alcohol swab prior to electrode placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Osteoarthritis | Experimental | Procedure: ArthrocentesisPatients with native knees and effusions will participate in this arm. |
| Primary TKA | Experimental | Procedure: ArthrocentesisPatients with total knee replacements will participate in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years or older with mild (1+) to severe (3+) knee effusion associated with underlying osteoarthritis (Kellgren and Lawrence grade II or higher) that undergo therapeutic aspiration
- Patients with symptomatic primary total knee arthroplasty without infection (as verified by prior aspiration) with moderate to severe effusion electing for therapeutic arthrocentesis. Must be minimum of 3 months from index surgery to be included.
Key exclusion criteria (12 listed)
- Patients with effusion related to trauma or another underlying condition (ie. fracture, ligamentous injury, hemarthrosis)
- Patients with known history of gout or with synovial fluid samples testing positive for urate of calcium pyrophosphate crystals
- Patients with knee effusion associated with septic arthritis or periprosthetic knee infection as determined from knee arthrocentesis.
- Patients with inflammatory arthritis (ie. JIA, RA, psoriatic arthritis, etc).
- Patients with revision knee arthroplasty, unicompartmental arthroplasty or other repair/reconstruction surgery
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 |
|---|---|---|
| ArthrocentesisPatients will receive a joint arthrocentesis to remove fluid from the joint. | Procedure or surgery | Primary Osteoarthritis, Primary TKA |
Primary outcome
Change in quadriceps activation
Time frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0),optional 7-10 days post aspiration
The change in quadriceps activation prior to and post arthrocentesis will be measured.
7 secondary outcomes
Change in Pain
Time frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Function
Time frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Range of Motion
Time frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Quadriceps Strength
Time frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Functional Performance
Time frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
Volume of Knee Synovial Fluid Aspirated
Time frame: Immediately post aspiration (day 0)
Bioelectrical Impedance
Time frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0), optional 7-10 days post aspiration
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 4 Nov 2026.
- Background: PubMed 18163497Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
- Background: PubMed 19407734Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6.
- Background: PubMed 23973124Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1145-53. doi: 10.1016/j.joca.2013.03.018.
- Background: PubMed 15766999Dieppe PA, Lohmander LS. Pathogenesis and management of pain in osteoarthritis. Lancet. 2005 Mar 12-18;365(9463):965-73. doi: 10.1016/S0140-6736(05)71086-2.
- Background: PubMed 22815119Egloff C, Hugle T, Valderrabano V. Biomechanics and pathomechanisms of osteoarthritis. Swiss Med Wkly. 2012 Jul 19;142:w13583. doi: 10.4414/smw.2012.13583. eCollection 2012.
- Individual participant dataSharing planned: No
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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.
Jason Jennings, MD principal investigator
Colorado Joint Replacement
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrocentesis in people with Effusion Joint, run by Colorado Joint Replacement at 2 sites 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 2 inclusion and 12 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Change in quadriceps activation (time frame: Immediately pre aspiration (day 0), immediately post aspiration (day 0),optional 7-10 days post aspiration). 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 NCT04146649, which also lists 5 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 4 Nov 2026.