Baker Cyst Dimensions and Intermittent Vacuum Therapy in Knee Osteoarthritis (BCIVT)

NCT06079684 | Completed

• 1 other identifier: BalnearRehabTechirghiol
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Baker Cyst; Knee Osteoarthritis

Keywords

Baker Cyst; Intermittent Vacuum; Knee Osteoarthritis; Ultrasonography; Physical therapy; Mud; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Cyst Baker Dimensions

  Ultrasonographic measurements

  Two measurements, on the first day of treatment and after 10 consecutive days of treatment

Study Arms (2)

Vacuum Group

EXPERIMENTAL

Vacuum Group with 32 patients: for 10 consecutive days, all patients performed the same program procedures: Intermittent vacuum therapy (for 30 minutes, with a Vacumed device -the lower body was positioned in the vacuum chamber, which was sealed around the participant's trunk with a cuff at the level of the umbilicus to allow application of negative pressure), 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 and kinesiotherapy with a standard program for peripheric joints for 30 minutes

Device: Intermittent vacuum therapy

Control Group

ACTIVE COMPARATOR

Control Group with 33 patients: for 10 consecutive days, all patients performed the same program procedures: 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 and kinesiotherapy with a standard program for peripheric joints for 30 minutes

Device: Intermittent vacuum therapy

Interventions

Intermittent vacuum therapy DEVICE

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.

Also known as: General warm mud bath, Hydrokinetotherapy in saline water, Massage therapy, Kinesiotherapy

Control Group; Vacuum Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• free consent based on explaining and understanding all related procedural steps;
• age over 18 years;
• diagnosis of knee osteoarthritis with Baker Cyst.

You may not qualify if:

• neurological conditions
• rheumatological conditions
• trauma
• a history of knee or lower extremity joint surgery,
• a history of hip or ankle pain
• a history of steroid injection in the previous three months,
• conditions that would be contraindicated by Intermittent Vacuum Therapy.

Sponsors & Collaborators

• Balnear and Rehabilitation Sanatorium Techirghiol: lead

Study Sites (1)

Balneal and Rehabilitation Sanatorium Techirghiol

Techirghiol, Constanța County, 906100, Romania

Location

Related Publications (36)

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MeSH Terms

Conditions

Popliteal Cyst; Osteoarthritis, Knee

Interventions

Massage

Condition Hierarchy (Ancestors)

Synovial Cyst; Cysts; Neoplasms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assit. Prof. Dr. Ionescu Elena Valentina

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 12, 2023
• Study Start: November 1, 2022
• Primary Completion: December 2, 2022
• Study Completion: December 16, 2022
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

RO (1)