NCT04785014

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
Last Updated

March 5, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

February 25, 2021

Last Update Submit

March 3, 2021

Conditions

Keywords

Baker's cystUltrasonography,Cyst aspirationKnee exercises for Baker's cystCold pack

Outcome Measures

Primary Outcomes (8)

  • Effect of USG-guided Baker's cyst aspiration

    Baker's cyst USG measurement width:mm

    12 week

  • Effect of USG-guided Baker's cyst aspiration

    Baker's cyst USG measurement length:mm

    12 week

  • Effect of USG-guided Baker's cyst aspiration

    Baker's cyst USG measurement area:mm\^2

    12 week

  • Effect of USG-guided Baker's cyst aspiration

    Visual Analog Score for pain

    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

    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

    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

    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

    12week

Study Arms (2)

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.

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.

Procedure: interventional

Interventions

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.

aspiration groupcontrol group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To have baker's cyst..
  • To comply with the treatment protocol
  • Signing the information consent form

You may not qualify if:

  • To have malignancy
  • To have neurological deficit
  • Those with coagulation disorders or those receiving anticoagulant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Popliteal Cyst

Interventions

Methods

Condition Hierarchy (Ancestors)

Synovial CystCystsNeoplasms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phd

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 5, 2021

Study Start

January 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 30, 2017

Last Updated

March 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

: 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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
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.
Access Criteria
To all researchers..