P-019 - A Retrospective Case Series Demonstrating the Effectiveness of Regenerative Injection Therapies in Chronic Pain Conditions

Abstract Title: A Retrospective Case Series Demonstrating the Effectiveness of Regenerative Injection Therapies in Chronic Pain Conditions


Background: Chronic pain is the leading cause of disability and global burden worldwide⁴. Degenerative changes in the musculoskeletal system is a primary cause of chronic pain. The knees, hands, hips, and spine are the most common areas affected. Regenerative medicine (RM) in pain management aims to address pain and dysfunction in musculoskeletal conditions caused by degenerative, overuse, or traumatic processes. The concept of RM has been applied since the 1930s. Regenerative Injection Therapies (RIT) use autologous and allogeneic solutions that act on native tissues to stimulate tissue repair. These solution include: Bone Marrow Aspiration Concentrate (BMAC), Platelet Rich Plasma (PRP), bioactive tissue matrix allograft (TMA), and nano-fat (NF). Indications for use include musculoskeletal or neurovascular injury, osteoarthritis (OA), and chronic pain syndrome. The safe and effective use of allogenic and autologous solutions has been well supported for over two decades.^1,4



The regenerative capacity of RIT on connective tissue has been previously demonstrated using post-procedure imaging and biopsies. ^2,3,5 Several clinical trials using RIT in the treatment of pain reveal symptomatic improvement in physical ability and quality of life. Large-scale investigations with long-term follow-up reveal a favorable safety and efficacy profile of RIT. The majority of adverse events are expected post-procedural pain.¹

Purpose/Objectives: Various elements influence the prevalence and severity of chronic pain including but not limited to socioeconomic status, genes, trauma, lifestyle, comorbidities, and behavioral factors. A biopsychosocial model of treatment carried out by multiple healthcare providers is the ideal approach to treatment. The aim of this study was to evaluate the effect of RIT on pain and disability. The safety of RIT was demonstrated as a secondary outcome.



RM has potential to be a part of the standard of care and should be considered when addressing musculoskeletal diseases. Current percutaneous pain management interventional therapies include cortisone injections, visco-supplementation, and neuromodulation. RIT offers itself as a safe and effective modality when properly processed, individualized, and delivered using image guidance. In this retrospective case series, we review the safety and efficacy of RIT in pain conditions using the visual analog scale and patient specific surveys for up to 24 months.


Methods: This retrospective review was approved by the Institutional Review Board at Sonoran University of Health Sciences. Patient encounters at the Neil Riordan Center for Regenerative Medicine were reviewed between 2020 and 2022 to investigate the efficacy of RIT. The search was narrowed to include only BMAC and TMA solutions. Thirty-two patients with musculoskeletal diseases were identified. Half of the patients were lost to follow-up and the remaining 16 patients’ VAS and survey scores were compared pre-treatment to post-treatment. All injections were performed using sterile technique with image guidance (fluoroscopy and or sonography).



The patients were self-selected to undergo RIT following informed consent. The etiology of patients’ concerns were due to osteoarthritis with and without tendinopathy, internal derangements of peripheral joints including hips, knees, hands, and shoulders, and spondylosis of the cervical and lumbar spine. Patients were followed and evaluated for up to two years using mailed surveys and phone calls. Treatment results were assessed using visual analog scale relevant orthopedic surveys.


Results: This study supports the safety and long-term value of RIT for the management of pain and disability of the hands, shoulder, knees, hips, and spine. In total, eight patients underwent injections for OA of the knee, two for the hip, two for the cervical zygapophyseal joints, three for lumbar zygapophyseal joints, one OA of the hand, two for OA of the shoulder, and six for sacroiliac joint dysfunction. Patients were not limited to one joint per treatment and surrounding ligaments and tendons were treated depending on indication. Twelve patients underwent injections in one area (unilateral or bilateral), three underwent three injection areas, and one had four regions injected. Zygapophyseal joint injections were not limited to one level or unilaterality.



Seventy-five percent of patients in this study reported clinical significant improvements in VAS score up to 24 months following RIT while 25% percent had no significant change in their condition according to the VAS.

This study investigated the effectiveness of an orthopedic treatment by analyzing patient-reported outcomes before and after treatment using various standardized surveys. Ten patients completed surveys including the SF-36, HOOS, KOOS, DASH, and ODI.

The results showed significant improvements in patient function, pain, and overall health perception across multiple surveys for a subset of patients. Notably:

• One patient showed significant improvement on the SF-36 subscales related to physical functioning, energy, pain, and general health.


• One patient with significant pain reduction (ODI) also demonstrated substantial improvement in arm/shoulder/hand disability (DASH).


• Three patients showed clinically significant improvements in knee symptoms, pain, function, and quality of life based on the KOOS.


• Two patients with significant improvements in hip disability and osteoarthritis outcomes were identified using the HOOS.

These findings suggest that RIT may be effective in improving patient function, pain, and overall health for some individuals. Further research with a larger sample size and randomization is needed to confirm these findings.

Conclusions/Implications for future research and/or clinical care: Current research has demonstrated the regenerative, anti-inflammatory, paracrine, and anti-fibrotic effects of autologous and allogenic therapies for musculoskeletal diseases in both in vivo and vitro studies.¹ The regenerative capacity of RIT have been demonstrated in numerous animal and human studies. The main mechanism of benefit is likely largely due to RIT promoting an anabolic environment through stem cell recruitment and inflammatory modulation. This study reveals clinically significant changes in pain and function in musculoskeletal conditions of the knee, hip, shoulder, and spine. Patient finances, number of areas treated, as well as age may have affected the patient outcome measures in this study. Our results support further utilization of RIT in practice and encourages further larger and long-term studies that are blinded and randomized.


References:

1. Centeno, Christopher J., et al. “A Multi-Center Analysis of Adverse Events among Two Thousand, Three Hundred and Seventy Two Adult Patients Undergoing Adult Autologous Stem Cell Therapy for Orthopaedic Conditions.” International Orthopaedics, vol. 40, no. 8, 2016, pp. 1755–1765., doi:10.1007/s00264-016-3162-y.


2. Chahla, Jorge, et al. “Concentrated Bone Marrow Aspirate for the Treatment of Chondral Injuries and Osteoarthritis of the Knee.” Orthopaedic Journal of Sports Medicine, vol. 4, no. 1, 2016, p. 232596711562548., doi:10.1177/2325967115625481.


3. Cotter, Eric J., et al. “Bone Marrow Aspirate Concentrate for Cartilage Defects of the Knee: From Bench to Bedside Evidence.” Cartilage, vol. 9, no. 2, 2017, pp. 161–170., doi:10.1177/1947603517741169.


4. Hernigou, P., Poignard, A., Beaujean, F., & Rouard, H. (2005). Percutaneous autologous bone-marrow grafting for nonunions. Influence of the number and concentration of progenitor cells. The Journal of Bone and Joint Surgery. American Volume, 87(7), 1430-1437. https://doi.org/10.2106/JBJS.D.02215


5. Mills, Sarah E.e., et al. “Chronic Pain: a Review of Its Epidemiology and Associated Factors in Population-Based Studies.” British Journal of Anaesthesia, vol. 123, no. 2, 2019, doi:10.1016/j.bja.2019.03.023.


6. Skowroński J, Rutka M. Osteochondral lesions of the knee reconstructed with mesenchymal stem cells—results. Ortop Traumatol Rehabil. 2013;15:195–204.