Clinical Site Coordinator Regenative Labs Pensacola, Florida
Abstract Title: Umbilical Cord Tissue Allograft for Ligamentous Defects in Patients with Sinus Tarsitis: A Case Series
Background: Sinus Tarsi syndrome is a condition that presents as lateral midfoot heel pain that is located in the “funnel-shaped” space between the calcaneus, talus, and talocalcaneonavicular and subtalar joints [1]. Patients with sinus tarsi syndrome generally complain of instability with functional activities and persistent anterolateral ankle discomfort [2]. The etiology of this condition is not well understood. Still, recent literature describes the instability primarily stemming from ligamentous injuries, inflammation from damage to the synovium, and fibrotic tissue infiltration of the subtalar joint space [2]. The incidence of sinus tarsi syndrome is unknown, but it is proposed that a large percentage of reported ankle sprain injuries include an injury to the subtalar joint ligaments [3]. Treatment recommendations include balance and proprioceptive training, muscle strengthening exercises, bracing, taping, and foot orthosis. NSAIDs are often used to help with pain management. For patients who fail standard-care treatments and rehabilitation, the option of arthroscopy exists for a more precise examination of the joint and to allow for surgical treatment [4]. Other surgeries include evacuation of Hoke’s Tonsil” and radiofrequency neuroablation to denervate the area. While surgery can be effective, it is invasive, and the mean return to total activity is four months.
Purpose/Objectives: Given that there are no single, optimal treatment options for sinus tarsi, there is a need for alternative interventions. This retrospective study assesses the efficacy of Wharton's Jelly (WJ) application to the damaged ligaments to minimize the pain associated with sinus tarsi. WJ is a loose connective tissue found in the umbilical cord that cushions and protects the vessels within the cord from external forces and stretching. It contains collagen types I and III, hyaluronic acid, proteoglycans, growth factors, and cytokines that supplement the damaged tissue. This retrospective case series presents the application of WJ to ligament defects in the sinus tarsi and sinus canalis of five females who have all failed previous standard-care treatments.
Methods: This study exemplifies significant pain improvement of the sinus tarsi after applying WJ in combination with EPAT, laser therapy, and, in some cases, a pneumatic boot. The results align with other literature's positive outcomes regarding each element used in the care procedure as stand-alone applications. EPAT has been reported to show successful outcomes in treating Achilles tendinopathy (Saxena, 2011). Class IV laser therapy was utilized to reduce pain and inflammation and to improve tissue modality. Additionally, laser therapy decreases erythrocyte deformability and platelet coagulation, resulting in membrane revitalization, viscosity reduction, and erythrocyte stress adaptation (Brandl, 2023). EPAT and laser therapy also promote blood flow, stimulating the body’s healing process. For patients who used a pneumatic boot, it stabilized and limited the range of motion to prevent further injury. Further research regarding the use of WJ for sinus tarsi ligament defects could be completed to compare the efficacy of WJ to standard-care treatments and surgery. A larger, more diverse, and randomized study would be beneficial in future studies to define dosage protocols further and confirm safety and efficacy.
Results: All patients were scheduled twice weekly for class IV laser therapy sessions for the two weeks following the tissue supplementation to provide photobiomodulation as an anti-inflammation and tissue healing stimulation modality. All patients were prescribed optional non-anti-inflammatory medication to help combat discomfort. After the initial application, all individuals were assessed at a follow-up visit approximately 80 days after the WJ application to evaluate pain improvement via a visual analog scale and to ensure no adverse side effects. The cohort’s initial average visual analog scale (VAS) score was 6.8, with a final VAS average of 1. The cohort had an overall 85.29% improvement in pain. All patients reported an improvement in pain. The least improved patient still had an improvement of 75%. One patient reported a pain improvement of 100%. No adverse reactions were reported. This study exemplifies significant pain improvement of the sinus tarsi after applying WJ in combination with EPAT, laser therapy, and, in some cases, a pneumatic boot. The results align with other literature's positive outcomes regarding each element used in the care procedure as stand-alone applications.
Conclusions/Implications for future research and/or clinical care: EPAT has been reported to show successful outcomes in treating Achilles tendinopathy [5]. Class IV laser therapy was utilized to reduce pain and inflammation and to improve tissue modality. Additionally, laser therapy decreases erythrocyte deformability and platelet coagulation, resulting in membrane revitalization, viscosity reduction, and erythrocyte stress adaptation [6]. EPAT and laser therapy also promote blood flow, stimulating the body’s healing process. For patients who used a pneumatic boot, it stabilized and limited the range of motion to prevent further injury. Further research regarding the use of WJ for sinus tarsi ligament defects could be completed to compare the efficacy of WJ to standard-care treatments and surgery. A larger, more diverse, and randomized study would be beneficial in future studies to define dosage protocols further and confirm safety and efficacy.
References: 1. Tu, P., & Bytomski, J. R. (2011). Diagnosis of heel pain. American family physician, 84(8), 909–916. 2. Helgeson K. (2009). Examination and intervention for sinus tarsi syndrome. North American journal of sports physical therapy: NAJSPT, 4(1), 29–37. 3. Hubbard, T. J., & Hertel, J. (2006). Mechanical contributions to chronic lateral ankle instability. Sports medicine (Auckland, N.Z.), 36(3), 263–277. https://doi.org/10.2165/00007256-200636030-00006 4. Oloff, L. M., Schulhofer, S. D., & Bocko, A. P. (2001). Subtalar joint arthroscopy for sinus tarsi syndrome: a review of 29 cases. The Journal of foot and ankle surgery: official publication of the American College of Foot and Ankle Surgeons, 40(3), 152–157. https://doi.org/10.1016/s1067-2516(01)80081-8. 5. Saxena, A., Ramdath, S., Jr, O'Halloran, P., Gerdesmeyer, L., & Gollwitzer, H. (2011). Extra-corporeal pulsed-activated therapy ("EPAT" sound wave) for Achilles tendinopathy: a prospective study. The Journal of foot and ankle surgery: official publication of the American College of Foot and Ankle Surgeons, 50(3), 315–319. https://doi.org/10.1053/j.jfas.2011.01.003 6. Brandl, A., Egner, C., Reisser, U., Lingenfelder, C., & Schleip, R. (2023). Influence of high-energy laser therapy to the patellar tendon on its ligamentous microcirculation: An experimental intervention study. PloS one, 18(3), e0275883. https://doi.org/10.1371/journal.pone.0275883