Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079684
Status:
COMPLETED
Last Update Posted:
2023-10-12
First Post:
2023-09-29
Brief Title:
Baker Cyst Dimensions and Intermittent Vacuum Therapy in Knee Osteoarthritis BCIVT
Sponsor:
Balnear and Rehabilitation Sanatorium Techirghiol
Organization:
Balnear and Rehabilitation Sanatorium Techirghiol
Study Overview
Official Title:
Clinical Evidence Regarding The Dynamic of Baker Cyst Dimensions After Intermittent Vacuum Therapy As Rehabilitation Treatment In Patients With Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCIVT
Brief 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
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
Detailed Description:
The study was a prospective randomized controlled single-blind study conducted at the Balneal and Rehabilitation Sanatorium Techirghiol BRST in Romania A total of 65 patients with knee osteoarthritis OA and Bakers cysts BCs were enrolled in the study The patients were randomly assigned to either an intermittent vacuum therapy IVT group or a control group
The IVT group received IVT in addition to standard physical therapy while the control group received standard physical therapy only IVT was performed daily for 30 minutes using a Vacumed device The device consists of an airtight vacuum chamber and a pump connected to a pressure control system During vacuum treatments participants were asked to lay themselves comfortably in a supine position The lower body was positioned in the vacuum chamber which was sealed around the participants trunk with a cuff at the level of the umbilicus to allow application of negative pressure Negative pressure cycles are created by alternating between removing air and venting the chamber to atmospheric pressure
The standard physical therapy program consisted of a general warm mud bath 20 minutes at 38 degrees Celsius hydrokinetotherapy in saline water from Lake Techirghiol by a certified physical therapist 20 minutes at 35 degrees Celsius massage therapy for paravertebral muscles shoulder and pelvis girdle kinesio-therapy with a standard program for peripheric joints for 30 minutes
All patients were assessed at baseline and after 10 days of treatment using a variety of clinical and functional measures including the volume of the BC 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 BMI and Kellgren-Lawrence classification
Also scores for the Knee Injury and Osteoarthritis Outcome Score KOOS the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC the Functional Independence measurement FIM the Fall Risk Score and the Visual Analogue Scale VAS were recorded at baseline and after 10 days
All patients were recruited at the BRST by a clinician blinded as to group allocation Each study group was composed through random allocation of the total sample with a 11 allocation ratio that was reported to patients by a different researcher who was neither the one who performed the treatment nor the one who performed the evaluation through a pre-specified allocation list who was concealed in a password-protected computer file
Of the total of 102 patients who were presented for hospitalization in the BRST between November and December 2022 only 65 completed the participation conditions being grouped into two groups of 33 and 32 respectively Due to the relatively small number of patients the statistical approach was a non-parametric one Independent Samples Mann Whitney U test Independent Sample Median Test Reb test Samples Wilcoxon Signed Rank test and Chi-Square test
The IVT group received IVT in addition to standard physical therapy while the control group received standard physical therapy only IVT was performed daily for 30 minutes using a Vacumed device The device consists of an airtight vacuum chamber and a pump connected to a pressure control system During vacuum treatments participants were asked to lay themselves comfortably in a supine position The lower body was positioned in the vacuum chamber which was sealed around the participants trunk with a cuff at the level of the umbilicus to allow application of negative pressure Negative pressure cycles are created by alternating between removing air and venting the chamber to atmospheric pressure
The standard physical therapy program consisted of a general warm mud bath 20 minutes at 38 degrees Celsius hydrokinetotherapy in saline water from Lake Techirghiol by a certified physical therapist 20 minutes at 35 degrees Celsius massage therapy for paravertebral muscles shoulder and pelvis girdle kinesio-therapy with a standard program for peripheric joints for 30 minutes
All patients were assessed at baseline and after 10 days of treatment using a variety of clinical and functional measures including the volume of the BC 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 BMI and Kellgren-Lawrence classification
Also scores for the Knee Injury and Osteoarthritis Outcome Score KOOS the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC the Functional Independence measurement FIM the Fall Risk Score and the Visual Analogue Scale VAS were recorded at baseline and after 10 days
All patients were recruited at the BRST by a clinician blinded as to group allocation Each study group was composed through random allocation of the total sample with a 11 allocation ratio that was reported to patients by a different researcher who was neither the one who performed the treatment nor the one who performed the evaluation through a pre-specified allocation list who was concealed in a password-protected computer file
Of the total of 102 patients who were presented for hospitalization in the BRST between November and December 2022 only 65 completed the participation conditions being grouped into two groups of 33 and 32 respectively Due to the relatively small number of patients the statistical approach was a non-parametric one Independent Samples Mann Whitney U test Independent Sample Median Test Reb test Samples Wilcoxon Signed Rank test and Chi-Square test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None