CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 65 enrolled
Drug / intervention
Intermittent vacuum therapydevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06079684
NCT06079684N/ACompleted

Clinical Evidence Regarding The Dynamic of Baker Cyst Dimensions After Intermittent Vacuum Therapy As Rehabilitation Treatment In Patients With Knee Osteoarthritis

Balnear and Rehabilitation Sanatorium Techirghiol·interventional·Posted Oct 12, 2023·Updated Oct 12, 2023

In Brief

A clinical study evaluating Intermittent vacuum therapy for Baker Cyst and Knee Osteoarthritis. Completed, enrolled 65 participants across 1 site.

Detailed Summary

The Baker cyst (BC), also known as the popliteal cyst or parameniscal cyst, is a fluid-filled sac that commonly develops in the posterior aspect of the knee, between the semimembranosus and medial head of the gastrocnemius. It is a common complication of knee osteoarthritis, and can also be associated with other conditions such as rheumatoid arthritis, gout, and meniscal tears. BCs are typically asymptomatic, but can cause pain, stiffness, and swelling in the back of the knee. In severe cases, they can rupture, leading to inflammation and pain in the calf. Physiotherapy is a common treatment for BCs, and has been shown to be effective in reducing size and symptoms. Intermittent vacuum therapy (IVT) is a type of physiotherapy that involves applying suction to the affected area. IVT is thought to work by increasing blood flow and lymphatic drainage, which can help to reduce inflammation and swelling. This study aims to evaluate the effectiveness of IVT in the treatment of BCs. A total of 65 patients with knee osteoarthritis and BCs will be recruited and randomized to either a control group or an IVT group. The control group will receive standard physiotherapy treatment, while the IVT group will receive IVT in addition to standard physiotherapy treatment. All patients will be assessed at baseline and after 10 days of treatment using a variety of clinical and functional measures, including the echo volume of the BC. The results of the study will be used to determine whether IVT is an effective treatment for BCs. This study is designed to contribute to the existing body of knowledge on the treatment of BCs. The results of the study will be of interest to clinicians, researchers, and patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRomania
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedOct 12, 2023
Enrollment StartNov 1, 2022
Primary CompletionDec 2, 2022
Study CompletionDec 16, 2022
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 2.7 years ago

Interventions

Intermittent vacuum therapydevice

Data on demographics and clinical conditions was gathered. The investigators collect the next features: sex, age, level of education, occupation, environment, degree of functional deficit, body mass index and Kellgren-Lawrence classification. Also, scores for the Knee Injury and Osteoarthritis Outcome Score, the Western Ontario and McMaster Universities Osteoarthritis Index, the Functional Independence measurement, the Fall Risk Score, and the Visual Analogue Scale were recorded at baseline and after 10 days. A blinded expert used a 7-15 MHz linear probe to take ultrasonographic measurements of Baker Cyst at baseline and after 10 days.