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P-099 - Umbilical Cord Connective Tissue Allograft Applications with EPAT and Class IV Lasers for Defects of the Plantar Fascia: A Retrospective Case Series

POSTER ABSTRACT
Location:  Exhibit Hall
Abstract Title: Umbilical Cord Connective Tissue Allograft Applications with EPAT and Class IV Lasers for Defects of the Plantar Fascia: A Retrospective Case Series

Background: Nearly one in ten people will experience plantar fasciopathy in their lifetime [1]. Several diverse pathologies, including neurologic, arthritic, traumatic, neoplastic, infectious, or vascular, may lead to plantar enthesopathy [2]. Chronic enthesopathy experienced in the plantar aspect of the foot may be Plantar Fasciosis (PF). Risk factors often include excessive running, high arch, obesity, and a sedentary lifestyle [3]. A study by Rano found that BMI plays a more significant role in plantar enthesopathy than foot structure [4]. Standard-of-care treatment options for plantar fasciosis often include corticosteroid injections, NSAIDs, night splints, taping, stretching, exercise, foot orthosis, and extracorporeal shock wave therapy [5]. If a patient has attempted standard care of treatment with no relief after 6 to 12 months, they may qualify for plantar fascia release surgery. While surgical interventions have shown some success, the removal of greater than 40% of the plantar fascia may have detrimental effects on other ligamentous and bony structures in the foot [6]. With the increased risk of detrimental effects after surgery and a potential increase in pain, there is a clear need for additional treatment options.

Purpose/Objectives: Wharton's Jelly (WJ), a loose connective tissue found in the umbilical cord, has recently grown in popularity, and literature supports its use to supplement damaged connective tissue elsewhere in the body. Wharton's jelly contains collagen types I, III, and V and fibrous structures comparable to the extracellular matrices (ECM) of human articular cartilage, tendons, and dermal tissues [7]. This retrospective report presents WJ supplementation of the plantar fascia alongside other conservative care practices, shockwave therapy, and class IV lasers to minimize the negative symptoms of plantar fasciosis.

Methods: This study included seven consenting individuals who presented with either left or right plantar fasciosis and had ultrasound evidence of structural tendon damage. All individuals had previously exhausted standard-of-care treatment options. The cohort is 57% males and 43% females aged from 47 to 66- years- old. Each individual received a single application of 1cc CryoPlus, class IV laser therapy, extracorporeal pulse-activated therapy (EPAT), and a boot. 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 an average of 11 weeks later to evaluate pain improvement and to ensure no adverse side effects. This series aims to present progress in patient-reported pain scales after the application of WJ to the site of tissue defect, including laser therapy, EPAT, and a pneumatic boot.


Results: Before applying the tissue allograft, most patients received EPAT at 11 Hrtz, 3.0 bars, and 3231 to 3432 pulses to the affected tissue. One patient received EPAT at 11 Hrtz, 1.4 bars, and 3532 pulses. The WJ product used in this study was 1cc of CryoPlus, a minimally manipulated tissue allograft containing 75mg of WJ tissue per 1 mL. While the patient received EPAT, CryoPlus was thawed slowly per laboratory guidelines in a 35-degree bath. The allograft was transplanted along the plantar medial origin of plantar fascia throughout the inflamed tissues utilizing MyLab 15.0 MHz real-time diagnostic ultrasound guidance with a 4 cm transducer head. Further “needling” in a pin-cushion technique with a 22 gauge needle was performed to encourage neovascularization. At the end of the procedure, the patients received either a left or right prefabricated pneumatic ankle-foot orthosis. Six patients were prescribed acetaminophen, and one was prescribed hydrocodone for pain management. The patients received class IV laser treatments twice a week for two weeks.
Before applying the tissue allograft, most patients received EPAT at 11 Hrtz, 3.0 bars, and 3231 to 3432 pulses to the affected tissue. One patient received EPAT at 11 Hrtz, 1.4 bars, and 3532 pulses. The WJ product used in this study was 1cc of CryoPlus, a minimally manipulated tissue allograft containing 75mg of WJ tissue per 1 mL. While the patient received EPAT, CryoPlus was thawed slowly per laboratory guidelines in a 35-degree bath. The allograft was transplanted along the plantar medial origin of plantar fascia throughout the inflamed tissues utilizing MyLab 15.0 MHz real-time diagnostic ultrasound guidance with a 4 cm transducer head. Further “needling” in a pin-cushion technique with a 22 gauge needle was performed to encourage neovascularization. At the end of the procedure, the patients received either a left or right prefabricated pneumatic ankle-foot orthosis. Six patients were prescribed acetaminophen, and one was prescribed hydrocodone for pain management. The patients received class IV laser treatments twice a week for two weeks. The results show significant improvement in pain after umbilical cord tissue allografts with laser therapy, EPAT, and a boot.


Conclusions/Implications for future research and/or clinical care: In conclusion, the observational data obtained from the seven patients presenting with defects of the Plantar Fascia leading to Plantar Fasciosis reports WJ in combination with EPAT, laser therapy, and a pneumatic boot can significantly improve pain. The success of this preliminary data prompts further randomized control trials to compare this alternative protocol with the current non-surgical standard of care options. Future implications for the use of WJ in conjunction with standard care practices could greatly improve patient outcomes and potentially prevent or postpone invasive surgical procedures in many musculoskeletal defects.

References:


  1. Trojian T, Tucker AK. Plantar Fasciitis. Am Fam Physician. 2019 Jun 15;99(12):744-750. PMID: 31194492.



  2. Thomas, J. L., Christensen, J. C., Kravitz, S. R., Mendicino, R. W., Schuberth, J. M., Vanore, J. V., Weil, L. S., Sr, Zlotoff, H. J., Bouché, R., Baker, J., & American College of Foot and Ankle Surgeons heel pain committee (2010). The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. The Journal of foot and ankle surgery: official publication of the American College of Foot and Ankle Surgeons, 49 (3 Suppl), S1–S1 9. https://doi.org/10.1053/j.jfas.2010.01.001



  3. Goff, J. D., & Crawford, R. (2011). Diagnosis and treatment of plantar fasciitis. American family physician, 84(6), 676–682.



  4. Rano, J. A., Fallat, L. M., & Savoy-Moore, R. T. (2001). Correlation of heel pain with body mass index and other characteristics of heel pain. The Journal of foot and ankle surgery: official publication of the American College of Foot and Ankle Surgeons, 40(6), 351–356. https://doi.org/10.1016/s1067-2516(01)80002-8



  5. Heide, M., Mørk, M., Røe, C., Brox, J. I., & Fenne Hoksrud, A. (2020). The effectiveness of radial extracorporeal shock wave therapy (rESWT), sham-rESWT, standardised exercise programme or usual care for patients with plantar fasciopathy: study protocol for a double-blind, randomised, sham-controlled trial. Trials, 21(1), 589. https://doi.org/10.1186/s13063-020-04510-z.



  6. Thompson, J., Saini, S., Reb, C. & Daniel, J. (2014). Diagnosis and Management of Plantar Fasciitis. Journal of Osteopathic Medicine, 114(12), 900-901. https://doi.org/10.7556/jaoa.2014.177



  7. Sobolewski, K., Bańkowski, E., Chyczewski, L., & Jaworski, S. (1997). Collagen and glycosaminoglycans of Wharton's jelly. Biology of the neonate, 71(1), 11–21. https://doi.org/10.1159/000244392



  8. Rajfur, K., Rajfur, J., Matusz, T., Walewicz, K., Dymarek, R., Ptaszkowski, K., & Taradaj, J. (2022). Efficacy of Focused Extracorporeal Shock Wave Therapy in Chronic Low Back Pain: A Prospective Randomized 3-Month Follow-Up Study. Medical science monitor: international medical journal of experimental and clinical research, 28, e936614. https://doi.org/10.12659/MSM.936614



  9. 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



  10. 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