Baker CystNCT04785014
Effect of USG-guided Baker's Cyst Aspiration
A study testing interventional in people with Baker Cyst and Knee Disease, run by Erzurum Regional Training & Research Hospital.
Trial summary
ABSTRACT Objective: The aim of this study was to investigate the effect of ultrasonography (USG)-guided Baker's cyst (BC) aspiration in the treatment of BC. Design: A total of 40 patients presented to our polyclinic with the complaints of swelling at the back of the knee. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Baker Cyst, Knee Disease
- What is being tested?
- interventional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Jun 2017
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To have baker's cyst..
- To comply with the treatment protocol
- Signing the information consent form
Who cannot join
- To have malignancy
- To have neurological deficit
- Those with coagulation disorders or those receiving anticoagulant therapy
About this study
ABSTRACT Objective: The aim of this study was to investigate the effect of ultrasonography (USG)-guided Baker's cyst (BC) aspiration in the treatment of BC.
Design: A total of 40 patients presented to our polyclinic with the complaints of swelling at the back of the knee. The 40 patients were randomly divided into two groups: (I) aspiration group (n=20) and (II) control group (n=20). In the aspiration group, BC content was aspirated percutaneously under USG guidance, whereas no aspiration was performed in the control group. Additionally, the participants in both groups were trained on how to perform exercises and were also recommended to practice cold treatment for 15 min both in the morning and evening for 2 weeks. All the patients were followed up with USG at the first and third months, VAS, WOMAC, NHP , Lysholm and Cincinnati. The success of the treatment was demonstrated by the decrease in the width, length and area of the BCs and Lysholm, Cincinnati ,VAS, WOMAC and NHP scores.
Read the detailed description
Objective: The aim of this study was to investigate the effect of ultrasonography (USG)-guided Baker's cyst (BC) aspiration in the treatment of BC.
Design: This prospective study was conducted at Erzurum Atatürk University Medical Faculty Physical Medicine and Rehabilitation Department between January 2016 and June 2017 for a total period of 18 months. A total of 40 patients (11 males, 29 females) aged between 33-71 (mean age, 55.9 ± 9.6) years presented to our polyclinic with the complaints of swelling at the back of the knee. All the patients signed an informed consent form and the study was approved by the local ethics committee. (ERZURUM ATATUK UNIVERSITY MEDICAL FACULTY CLINICAL RESEARCH ETHICS COMMITTEE Date:03.12.2015 Meeting Number:8 Decision Number:24) Patients with a history of malignancy, coagulation disorder, and a neurological deficit and those receiving anticoagulant therapy were excluded from the study. The sample size was determined with a 95% confidence interval according to https://www.macorr.com/sample-size-calculator.htm website.
Prior to the procedure, all the patients were evaluated with grey-scale USG using an Esaote MyLab 60 USG device with a linear probe of 7.5 MHz. On USG examination, the area of transverse diameter(width-parallel to the knee joint), longitudinal diameter (length-perpendicular to the knee joint), and the USG area( from the widest place viewed) of BCs were calculated and recorded.
Clinical complaints of the patients, long-term complaints, and the history of medical, interventional, and surgical treatments were reviewed for each patient. Patients were also investigated for acute local or systemic infections.
The severity of clinical complaints was assessed using VAS, WOMAC knee osteoarthritis index, Lysholm knee scoring scale, Cincinnati knee rating system, and NHP. Patients with BC who had no contraindications for treatment and completed the WOMAC Knee osteoarthritis index, Lysholm knee scoring scale, Cincinnati knee rating system, VAS, and NHP and signed the patient consent form were included in the study. Patients were randomly divided into two groups by consecutive alternate allocation according to the time of admittance: (I) aspiration group (n=20) included the patients aspirated and (II) control group (n=20) included those who did not aspirated. In the aspirated group, the popliteal fossa areas were sterilized and BC content was aspirated from the popliteal fossa percutaneously under USG guidance with a 21-gauge needle (Figure 1). If the BC was septal, aspiration was performed from several different levels of the cyst so that the cyst content could be completely emptied. In contrast, no aspiration was performed in the control group. Additionally, the participants in both groups were trained on how to perform exercises and were also recommended to practice cold treatment for 15 min both in the morning and evening for 2 weeks.
After the aspiration, the patients were told how to exercise and practice cold treatment in the morning and evening for 2 weeks. Patients were discharged after a 30-min observation period following the procedure. Patients were allowed to apply bandages for 2 days after the procedure and were followed pre- and post-procedurally at the first and third months of treatment with WOMAC Knee osteoarthritis index, Lysholm knee scoring scale, Cincinnati knee rating system, VAS, and NHP and with USG. The appearance of BC at month 3 was examined on grey-scale USG and the length, width, and area of the cyst were recalculated. During the 3-month follow-up period, no additional treatment was performed in any patient. The success of the procedure was defined as reduction in BC width, length and area in sonographic measurements and decrease in the Lysholm knee scoring scale, Cincinnati knee rating system, VAS, WOMAC knee osteoarthritis index, and NHP scores.
- Conditions
- Baker Cyst, Knee Disease
- Being tested
- interventional
- Keywords
- Baker's cyst, Ultrasonography,, Cyst aspiration, Knee exercises for Baker's cyst, Cold pack
- Medical subject headings
- Popliteal Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventionalProcedure or surgery
In the aspirated group, the popliteal fossa areas were sterilized and BC content was aspirated from the popliteal fossa percutaneously under USG guidance with a 21-gauge needle (Figure 1). If the BC was septal, aspiration was performed from several different levels of the cyst so that the cyst content could be completely emptied.
| Study group | Role | What they receive |
|---|---|---|
| aspiration group | Experimental | In the aspirated group, the popliteal fossa areas were sterilized and BC content was aspirated from the popliteal fossa percutaneously under USG guidance with a 21-gauge needle (Figure 1). If the BC was septal, aspiration was performed from several different levels of the cyst so that the cyst content could be completely emptied.Additionally, the participants in both groups were trained on how to perform exercises and were also recommended to practice cold treatment for 15 min both in the morning and evening for 2 weeks. Receives: Procedure: interventional |
| control group | Active comparator | no aspiration was performed in the control group. Additionally, the participants in both groups were trained on how to perform exercises and were also recommended to practice cold treatment for 15 min both in the morning and evening for 2 weeks. Receives: Procedure: interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of USG-guided Baker's cyst aspiration
Baker's cyst USG measurement width:mm
Measured: 12 week
Effect of USG-guided Baker's cyst aspiration
Baker's cyst USG measurement length:mm
Measured: 12 week
Effect of USG-guided Baker's cyst aspiration
Baker's cyst USG measurement area:mm^2
Measured: 12 week
Effect of USG-guided Baker's cyst aspiration
Visual Analog Score for pain
Measured: 12week
Effect of USG-guided Baker's cyst aspiration
Western Ontario and McMaster Universities Arthritis Index (WOMAC) for Pain,Stiffness, and Physical Function .The minimum and maximum values respectively 0/96 and higher scores mean a worse outcome
Measured: 12week
Effect of USG-guided Baker's cyst aspiration
Nottingham Health Profile (NHP) for quality of life .The minimum and maximum values respectively 0/600 and higher scores mean a worse outcome
Measured: 12week
Effect of USG-guided Baker's cyst aspiration
Tegner Lysholm Knee Scoring Scale for how your knee pain has affected your ability to manage in everyday life. .The minimum and maximum values respectively 0/100 and higher scores mean a better outcome
Measured: 12week
Effect of USG-guided Baker's cyst aspiration
Cincinnati Knee Rating System score for a variety of symptoms, sports and daily activity functions, and objective physical findings.The minimum and maximum values respectively 0/30 and higher scores mean a better outcome
Measured: 12week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Jan 2016
- Primary completion1 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Baker CystStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzurum Regional Training & Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, nurmuhammet tas, Erzurum Regional Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785014
- Sponsor's protocol ID
- ErzurumRTRHh
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: : A total of 40 patients presented to our polyclinic with the complaints of swelling at the back of the knee. The 40 patients were randomly divided into two groups: (I) aspiration group (n=20) and (II) control group (n=20). In the aspiration group, BC content was aspirated percutaneously under USG guidance, whereas no aspiration was performed in the control group. Additionally, the participants in both groups were trained on how to perform exercises and were also recommended to practice cold treatment for 15 min both in the morning and evening for 2 weeks. All the patients were followed up with USG at the first and third months, VAS, WOMAC, NHP , Lysholm and Cincinnati. The success of the treatment was demonstrated by the decrease in the width, length and area of the BCs and Lysholm, Cincinnati ,VAS, WOMAC and NHP scores.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of USG-guided Baker's Cyst Aspiration
- ClinicalTrials.gov ID
- NCT04785014
- Acronym / sponsor ID
- ErzurumRTRHh
- Conditions
- Baker Cyst, Knee Disease
- Keywords
- Baker's cyst, Ultrasonography,, Cyst aspiration, Knee exercises for Baker's cyst, Cold pack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Erzurum Regional Training & Research HospitalOther government
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 5 Mar 2021 (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.
ABSTRACT Objective: The aim of this study was to investigate the effect of ultrasonography (USG)-guided Baker's cyst (BC) aspiration in the treatment of BC.
Design: A total of 40 patients presented to our polyclinic with the complaints of swelling at the back of the knee. The 40 patients were randomly divided into two groups: (I) aspiration group (n=20) and (II) control group (n=20). In the aspiration group, BC content was aspirated percutaneously under USG guidance, whereas no aspiration was performed in the control group. Additionally, the participants in both groups were trained on how to perform exercises and were also recommended to practice cold treatment for 15 min both in the morning and evening for 2 weeks. All the patients were followed up with USG at the first and third months, VAS, WOMAC, NHP , Lysholm and Cincinnati. The success of the treatment was demonstrated by the decrease in the width, length and area of the BCs and Lysholm, Cincinnati ,VAS, WOMAC and NHP scores.
Detailed description
Objective: The aim of this study was to investigate the effect of ultrasonography (USG)-guided Baker's cyst (BC) aspiration in the treatment of BC.
Design: This prospective study was conducted at Erzurum Atatürk University Medical Faculty Physical Medicine and Rehabilitation Department between January 2016 and June 2017 for a total period of 18 months. A total of 40 patients (11 males, 29 females) aged between 33-71 (mean age, 55.9 ± 9.6) years presented to our polyclinic with the complaints of swelling at the back of the knee. All the patients signed an informed consent form and the study was approved by the local ethics committee. (ERZURUM ATATUK UNIVERSITY MEDICAL FACULTY CLINICAL RESEARCH ETHICS COMMITTEE Date:03.12.2015 Meeting Number:8 Decision Number:24) Patients with a history of malignancy, coagulation disorder, and a neurological deficit and those receiving anticoagulant therapy were excluded from the study. The sample size was determined with a 95% confidence interval according to https://www.macorr.com/sample-size-calculator.htm website.
Prior to the procedure, all the patients were evaluated with grey-scale USG using an Esaote MyLab 60 USG device with a linear probe of 7.5 MHz. On USG examination, the area of transverse diameter(width-parallel to the knee joint), longitudinal diameter (length-perpendicular to the knee joint), and the USG area( from the widest place viewed) of BCs were calculated and recorded.
Clinical complaints of the patients, long-term complaints, and the history of medical, interventional, and surgical treatments were reviewed for each patient. Patients were also investigated for acute local or systemic infections.
The severity of clinical complaints was assessed using VAS, WOMAC knee osteoarthritis index, Lysholm knee scoring scale, Cincinnati knee rating system, and NHP. Patients with BC who had no contraindications for treatment and completed the WOMAC Knee osteoarthritis index, Lysholm knee scoring scale, Cincinnati knee rating system, VAS, and NHP and signed the patient consent form were included in the study. Patients were randomly divided into two groups by consecutive alternate allocation according to the time of admittance: (I) aspiration group (n=20) included the patients aspirated and (II) control group (n=20) included those who did not aspirated. In the aspirated group, the popliteal fossa areas were sterilized and BC content was aspirated from the popliteal fossa percutaneously under USG guidance with a 21-gauge needle (Figure 1). If the BC was septal, aspiration was performed from several different levels of the cyst so that the cyst content could be completely emptied. In contrast, no aspiration was performed in the control group. Additionally, the participants in both groups were trained on how to perform exercises and were also recommended to practice cold treatment for 15 min both in the morning and evening for 2 weeks.
After the aspiration, the patients were told how to exercise and practice cold treatment in the morning and evening for 2 weeks. Patients were discharged after a 30-min observation period following the procedure. Patients were allowed to apply bandages for 2 days after the procedure and were followed pre- and post-procedurally at the first and third months of treatment with WOMAC Knee osteoarthritis index, Lysholm knee scoring scale, Cincinnati knee rating system, VAS, and NHP and with USG. The appearance of BC at month 3 was examined on grey-scale USG and the length, width, and area of the cyst were recalculated. During the 3-month follow-up period, no additional treatment was performed in any patient. The success of the procedure was defined as reduction in BC width, length and area in sonographic measurements and decrease in the Lysholm knee scoring scale, Cincinnati knee rating system, VAS, WOMAC knee osteoarthritis index, and NHP scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aspiration group | Experimental | Procedure: interventionalIn the aspirated group, the popliteal fossa areas were sterilized and BC content was aspirated from the popliteal fossa percutaneously under USG guidance with a 21-gauge needle (Figure 1). If the BC was septal, aspiration was performed from several different levels of the cyst so that the cyst content could be completely emptied.Additionally, the participants in both groups were trained on how to perform exercises and were also recommended to practice cold treatment for 15 min both in the morning and evening for 2 weeks. |
| control group | Active comparator | Procedure: interventionalno aspiration was performed in the control group. Additionally, the participants in both groups were trained on how to perform exercises and were also recommended to practice cold treatment for 15 min both in the morning and evening for 2 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To have baker's cyst..
- To comply with the treatment protocol
- Signing the information consent form
Key exclusion criteria (3 listed)
- To have malignancy
- To have neurological deficit
- Those with coagulation disorders or those receiving anticoagulant therapy
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 |
|---|---|---|
| interventionalIn the aspirated group, the popliteal fossa areas were sterilized and BC content was aspirated from the popliteal fossa percutaneously under USG guidance with a 21-gauge needle (Figure 1). If the BC was septal, aspiration was performed from several different levels of the cyst so that the cyst content could be completely emptied. | Procedure or surgery | aspiration group, control group |
Primary outcome
Effect of USG-guided Baker's cyst aspiration
Time frame: 12 week
Baker's cyst USG measurement width:mm
Effect of USG-guided Baker's cyst aspiration
Time frame: 12 week
Baker's cyst USG measurement length:mm
Effect of USG-guided Baker's cyst aspiration
Time frame: 12 week
Baker's cyst USG measurement area:mm^2
Effect of USG-guided Baker's cyst aspiration
Time frame: 12week
Visual Analog Score for pain
Effect of USG-guided Baker's cyst aspiration
Time frame: 12week
Western Ontario and McMaster Universities Arthritis Index (WOMAC) for Pain,Stiffness, and Physical Function .The minimum and maximum values respectively 0/96 and higher scores mean a worse outcome
Effect of USG-guided Baker's cyst aspiration
Time frame: 12week
Nottingham Health Profile (NHP) for quality of life .The minimum and maximum values respectively 0/600 and higher scores mean a worse outcome
Effect of USG-guided Baker's cyst aspiration
Time frame: 12week
Tegner Lysholm Knee Scoring Scale for how your knee pain has affected your ability to manage in everyday life. .The minimum and maximum values respectively 0/100 and higher scores mean a better outcome
Effect of USG-guided Baker's cyst aspiration
Time frame: 12week
Cincinnati Knee Rating System score for a variety of symptoms, sports and daily activity functions, and objective physical findings.The minimum and maximum values respectively 0/30 and higher scores mean a better outcome
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 5 Mar 2021.
- Individual participant dataSharing planned: Yes. : A total of 40 patients presented to our polyclinic with the complaints of swelling at the back of the knee. The 40 patients were randomly divided into two groups: (I) aspiration group (n=20) and (II) control group (n=20). In the aspiration group, BC content was aspirated percutaneously under USG guidance, whereas no aspiration was performed in the control group. Additionally, the participants in both groups were trained on how to perform exercises and were also recommended to practice cold treatment for 15 min both in the morning and evening for 2 weeks. All the patients were followed up with USG at the first and third months, VAS, WOMAC, NHP , Lysholm and Cincinnati. The success of the treatment was demonstrated by the decrease in the width, length and area of the BCs and Lysholm, Cincinnati ,VAS, WOMAC and NHP scores.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing interventional in people with Baker Cyst and Knee Disease, run by Erzurum Regional Training & Research Hospital.
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 3 inclusion and 3 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 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Effect of USG-guided Baker's cyst aspiration (time frame: 12 week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2021.