Clinical trial · Interventional
Baker Cyst Dimensions and Intermittent Vacuum Therapy in Knee Osteoarthritis (BCIVT)
Clinical Evidence Regarding The Dynamic of Baker Cyst Dimensions After Intermittent Vacuum Therapy As Rehabilitation Treatment In Patients With Knee Osteoarthritis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Baker Cyst | — | UNRESOLVED | — |
| Knee Osteoarthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intermittent vacuum therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vacuum Group
- description
- 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
- interventionNames
- Device: Intermittent vacuum therapy
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * free consent based on explaining and understanding all related procedural steps; * age over 18 years; * diagnosis of knee osteoarthritis with Baker Cyst. Exclusion Criteria: * 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.
References
Publications (36)
- BACKGROUNDAbate M, Di Carlo L, Di Iorio A, Salini V. Baker's Cyst with Knee Osteoarthritis: Clinical and Therapeutic Implications. Med Princ Pract. 2021;30(6):585-591. doi: 10.1159/000518792. Epub 2021 Aug 2. PMID 34348320
- BACKGROUNDHenricsdotter C, Ellegaard K, Klokker L, Bartholdy C, Bandak E, Bartels EM, Bliddal H, Henriksen M. Changes in ultrasound assessed markers of inflammation following intra-articular steroid injection combined with exercise in knee osteoarthritis: exploratory outcome from a randomized trial. Osteoarthritis Cartilage. 2016 May;24(5):814-21. doi: 10.1016/j.joca.2015.12.010. Epub 2015 Dec 31. PMID 26746147
- BACKGROUNDDi Sante L, Paoloni M, Ioppolo F, Dimaggio M, Di Renzo S, Santilli V. Ultrasound-guided aspiration and corticosteroid injection of Baker's cysts in knee osteoarthritis: a prospective observational study. Am J Phys Med Rehabil. 2010 Dec;89(12):970-5. doi: 10.1097/PHM.0b013e3181fc7da2. PMID 21403593
- BACKGROUNDZhou XN, Li B, Wang JS, Bai LH. Surgical treatment of popliteal cyst: a systematic review and meta-analysis. J Orthop Surg Res. 2016 Feb 15;11:22. doi: 10.1186/s13018-016-0356-3. PMID 26879283
- BACKGROUNDWiecha S, Jarocka M, Wisniowski P, Cieslinski M, Price S, Makaruk B, Kotowska J, Drabarek D, Cieslinski I, Sacewicz T. The efficacy of intermittent pneumatic compression and negative pressure therapy on muscle function, soreness and serum indices of muscle damage: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2021 Nov 13;13(1):144. doi: 10.1186/s13102-021-00373-2. PMID 34774089
- BACKGROUNDParganlija D, Nieberg V, Sauer M, Rittweger J, Bloch W, Zange J. Lower body negative pressure enhances oxygen availability in the knee extensor muscles during intense resistive exercise in supine position. Eur J Appl Physiol. 2019 Jun;119(6):1289-1303. doi: 10.1007/s00421-019-04113-w. Epub 2019 Mar 26. PMID 30915538