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Clinical Trials/NCT04785014
NCT04785014CompletedNot Applicable

Effect of USG-guided Baker's Cyst Aspiration

Erzurum Regional Training & Research Hospital0 sites40 target enrollmentStarted: January 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Primary Endpoint
Effect of USG-guided Baker's cyst aspiration

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: interventional (Procedure)

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.

Intervention: interventional (Procedure)

Outcomes

Primary Outcomes

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: 12 week

Baker's cyst USG measurement width:mm

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Erzurum Regional Training & Research Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

nurmuhammet tas

phd

Erzurum Regional Training & Research Hospital

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