Comparative Efficacy of Ultrasound-Guided Cervical Fascial Infiltration versus Periarticular Administration of Autologous Conditioned Serum (Orthokine) for Neck Pain: A Randomized Controlled Trial Protocol Description.

BACKGROUND Neck pain is a prevalent and burdensome health issue, with autologous conditioned serum (ACS), like Orthokine, being a recognized treatment for musculoskeletal conditions due to its anti-inflammatory effects. However, the optimal ACS administration method for neck pain remains unclear. The existing literature lacks robust evidence, especially for different injection techniques. This study aimed to compare ACS infiltration into cervical fascia with periarticular administration to determine if the former is as effective in alleviating neck pain, offering a novel approach to its management. MATERIAL AND METHODS Our study is designed to be a single-center, prospective, randomized trial involving 100 patients. Group A (n=50) will receive ACS through fascial infiltration at tender points under ultrasound guidance, with 4 doses administered every 3 days. Group B (n=50) will receive ACS injections in the articular column (facet joints) using the same dosing schedule. We will collect data at T0 (before therapy), T1 (6 weeks after therapy), and T2 (12 weeks after therapy), assessing outcomes with the Numerical Pain Scale (NRS), Neck Disability Index (NDI), and Dynamic Proprioception Test (DPT). RESULTS Enrollment begins in August 2023, and the study is set to conclude in July 2024. If data analysis, manuscript preparation, and peer review proceed smoothly, we anticipate publishing the results in late 2024 or early 2025. CONCLUSIONS If fascial infiltration with ACS proves equally effective as the standard periarticular method, it offers promise for patients on long-term anticoagulant treatment. Paravertebral injections in such cases carry a significant risk of bleeding, making ACS infiltration a potentially safer alternative for managing neck pain in these individuals.

Comparison of Analgesic Efficacy between Epidural and Perineural Administration of Autologous Conditioned Serum in the Conservative Treatment of Low Back Pain Due to Lumbar Degenerative Disc Disease: A Randomized, Open-Label, Controlled Clinical Trial.

Lumbar degenerative disc disease (LDDD) is widely acknowledged as a significant contributor to low back pain (LBP), which is a prevalent and debilitating health condition affecting millions of individuals worldwide. The pathogenesis of LDDD and associated pain mechanisms are thought to be mediated by inflammatory mediators. Autologous conditioned serum (ACS, Orthokine) may be used for symptomatic treatment of LBP due to LDDD. This study aimed to compare the analgesic efficacy and safety of two routes of ACS administration, perineural (periarticular) and epidural (interlaminar), in the conservative treatment of LBP. This study used an open-label, randomized, controlled trial protocol. A group of 100 patients were enrolled in the study and randomly allocated into two comparative groups. Group A (n = 50) received the epidural (interlaminar) approach-2 ultrasound-guided injections as control intervention (each containing two doses of ACS-8 mL). Group B (n = 50) received the perineural (periarticular) approach-2 ultrasound-guided injections as experimental intervention at 7-day intervals (the same volume of ACS). Assessments consisted of an initial assessment (IA) and control assessments at 4 (T1), 12 (T2), and 24 (T3) weeks after the last intervention. Primary outcomes comprised Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), Roland Morris Questionnaire (RMQ), and Euro Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Index, Visual Analogue Scale (VAS), and Level Sum Score (LSS). Secondary outcomes included differences between groups in specific endpoints for the above-mentioned questionnaires. In conclusion, this study revealed that both perineural (periarticular) and epidural ACS injections tended to perform in a very similar way. Both routes of Orthokine application show significant improvement in the primary clinical parameters, such as pain and disability, and therefore, both methods can be considered equally effective in managing LBP due to LDDD.

Safety of Epidural Hyaluronic Acid Injections in Managing the Symptoms of Lumbar Foraminal Stenosis: A Prospective Preliminary Study.

Lumbar foraminal stenosis (LFS) of degenerative origin is a common reason for distorted neurodynamics of nerve roots, causing radicular pain that is difficult to resolve with conservative treatments. A hyaluronic acid (HA), providing a sliding layer in the mechanical interface of a nerve root in a narrowed lateral recess, could potentially improve its neurodynamics and the trophic, leading to radicular pain reduction and improvement of function. This study aimed to assess the usefulness of ultrasound-guided HA epidural injections combined with neuromobilization in the conservative treatment of LFS. A group of 10 consecutively admitted patients with MRI-confirmed LFS and reduced straight leg raise (SLR) test results were qualified for a single HA epidural injection along with self-performed neuromobilization. Three measurement tools were used for primary outcomes: the numeric rating scale (NRS) for pain intensity, the Oswestry disability index (ODI) and the Roland-Morris questionnaire (RMQ) for disability level, and the angle of pain-free elevation in the SLR test as a functional assessment. The treatment was accomplished in all patients (100%). Overall, 60% of the patients completed all follow-up visits. There were no statistically significant differences regarding the results of the NRS, ODI, or RMQ; however, a statistically significant increase in the results of the SLR test was noted (p = 0.015). Three patients reported a flare-up of the symptoms shortly after injection but without neurological deficits. In conclusion, an epidural HA injection combined with a self-administered exercise program is a promising method and might be a beneficial way to enhance the neurodynamics of nerve roots in LFS and offer an option for steroid treatment. However, this method of epidural HA administration in LFS should be verified in further studies to confirm its efficiency and safety.

Collagen and platelet-rich plasma in partial-thickness rotator cuff injuries. Friends or only indifferent neighbours? Randomised controlled trial.

BACKGROUND: Partial-thickness rotator cuff injuries (PTRCI) are the sum of degenerative, overload, and microtrauma processes. An external supply of collagen and platelet-rich plasma (PRP) could potentially counteract the deterioration of degenerative tendinopathy. This study aimed to compare the effectiveness of collagen with PRP, PRP alone, and collagen alone in the treatment of PTRCI. METHODS: Ninety patients with PTRCI were randomised and treated with ultrasound-guided injections into the shoulder bursa every consecutive week: Group A - collagen with PRP (n = 30), Group B - collagen alone (n = 30), and Group C - PRP alone (n = 30). Primary outcomes were pain intensity measured in control points on a numeric rating scale (NRS), QuickDash, and EQ-5D-5L questionnaires at the initial assessment (IA) and control assessments after 6 (T1), 12 (T2), and 24 (T3) weeks, respectively. RESULTS: No statistical differences were found between groups in primary outcomes, although there was a trend towards improvement in Groups A and C (opposite to Group B) between T2 and T3. The following parameters were also observed: rotator cuff discontinuity (n = 3, one case in each group) and rotator cuff regeneration (n = 22 in Group A, n = 20 in Group B, and n = 23 in Group C). CONCLUSIONS: Combined therapy of collagen and PRP in PTRCI presents similar effectiveness to monotherapies with collagen or PRP. TRIAL REGISTRATION: The study was prospectively registered on the NCT Trial Center (identification number: NCT04492748 ) on 30.07.2020.

GOLDIC therapy in degenerative lumbar spinal stenosis: randomized, controlled trial.

Aim: Comparison of the efficacy of conservative treatment methods: epidural GOLDIC serum, epidural steroid injections, manual therapy. Materials & methods: A randomized, controlled trial. Three groups, each containing 30 patients. GOLDIC or steroid injections (dexamethasone) epidural versus manual therapy. Assessment: initial assessment and 4 (T1), 12 (T2) and 24 (T3) weeks after the last intervention. Primary outcomes: Pain intensity in numeric rating scale, Oswestry disability index, Zurich claudication questionnaire, EQ-5D-5L questionnaire. Results: GOLDIC has shown the highest mean differences and number of cases with minimal important difference among groups for every primary outcome. Conclusion: GOLDIC therapy could be a new option for the nonoperative, symptomatic treatment of degenerative lumbar spinal stenosis and is not inferior to epidural steroid injections and manual therapy.

This paper presents a comparative study of three methods of nonoperative treatment used in stenosis (narrowing) of the spinal canal in the lumbar region. The study was performed on 90 people with this kind of disease, which usually causes low back pain, combined with weakening of the muscle strength of the lower limbs and a significant shortening of walking distance. It turned out that autologous serum GOLDIC administered by epidural injection (into the vertebral canal) showed a stronger and longer-lasting analgesic effect and helped patients maintain better mobility during the 24-week follow-up period. Clinical Trial Registration: NCT04492774 (ClinicalTrials.gov).

High Volume PRP Therapy.

BACKGROUND: The PRP method is widely used to support healing and regeneration in musculoskeletal and aesthetic medicine. The current literature, however, brings contradictory reports as to its effectiveness, which, at least in part, should be attributed to the diversity of methods for producing the concentrate, including the use of various volumes of whole blood, single vs double centrifugation vs filtration, use of thrombin vs calcium chloride to activate the process, and, finally, the use of an anticoagulant. The aim of the study was to retrospectively evaluate the effectiveness of high-volume PRP therapy with the Angel® system (Arthrex) in our patients. MATERIAL AND METHODS: A total of 400 therapies were performed on 299 patients. The most frequently represented indications were knee osteoarthritis (OA), n = 164, including mild (n = 30), moderate (n = 38), and advanced (n = 96) stage; lumbar degenerative disc disease (LDDD), n = 54; rotator cuff injuries (RCI), n = 52; lumbar spinal stenosis (LSS), n = 37; cervical degenerative disc disease (CDDD), n = 17; and shoulder OA, n = 12. Therapies for LDDD and LSS patients were additionally divided with respect to the route of administration (periradicular vs epidural). The assessment tool was the modified Macnab scale. Follow-up examinations were performed at two and six months after PRP administration. Indicators of treatment success were defined as the percentage of satisfactory results and the percentage ratio of satisfactory results to non-satisfactory results after 2 and 6 months of follow-up (S/NS2 and S/NS6). For the advanced stage of knee OA, the results were compared in three age groups (under 66, 67-73 and over 74). RESULTS: For the entire treatment group, the mean S/NS2 ratio was 1.56; in the group of the most frequently represented indications, the highest satisfaction ratio was obtained in LDDD (2.84), and the lowest in the group of RCI (0.96). The mean value of the S/ NS6 ratio was 2.24, being the highest in mild knee OA (4.79) and CDDD (4.67), and the lowest in shoulder OA (0.72). In the age group over 74 years, the frequency of non-satisfactory results shows an increase in patients with advanced knee OA. CONCLUSIONS: 1. High-volume PRP therapy can be used as a local regenerative and anti-inflammatory treatment, demonstrating the highest efficacy in early knee OA and CDDD. 2. High PRP therapy demonstrates a high safety profile. 3. The final effects of the therapy develop over a period of several months of follow-up and depend on the severity of the degenerative process and the patient's age.

Evaluation of the Effectiveness of Orthokine Therapy: Retrospective Analysis of 1000 Cases.

BACKGROUND: Osteoarthritis is a global health problem. Approaches to symptomatic treatment of its consequences in-clude biological methods, including autologous serum. The aim of the study was to evaluate the effectiveness of Orthokine therapy in our experience. MATERIAL AND METHODS: Retrospective analysis of 1000 cases. The results were evaluated on a modified McNab scale (A - excellent, B - good, C - fair, D - poor) two and six months after the end of therapy. The effectiveness of the therapy was estimated as the percentage of satisfactory (A or B) or unsatisfactory (C or D) results. RESULTS: Osteoarthritis of the lumbar spine (n = 400) and knee joint (n = 219) was the most common diagnosis. The highest percentage of patients with a grade A or B result after 6 months was seen with therapy of tennis elbow enthesopathy (88.2%), rotator cuff tendinopathy (72.0%), Achilles tendon tendinopathy (75.0%) and in the early stages of osteoarthritis of the knee (75.9%) and small joints of the hand (77.0%). For cervical and lumbar discopathy, treatment efficacy was at 56.0-62.0% regardless of the size of the hernia. Unsatisfactory results (C and D) predominated in the group of patients with lumbar spinal stenosis (66.1%), wrist osteoarthritis (66.7%), and especially in late-stage hip osteoarthritis (85.3 %). For the largest groups, the frequency of unsatisfactory results was analyzed for selected age ranges. A significant increase in this parameter in subjects over 75 years of age was only seen in patients with severe knee osteoarthritis. CONCLUSIONS: 1. Orthokine therapy is highly effective in cases of tendinopathy, enthesopathy, osteoarthritis of the small joints of the hand and in early stages of knee osteoarthritis. 2. Satisfactory results are achieved in the treatment of cervical and lumbar discopathy, while unsatisfactory results prevail in severe degenerative changes in the knee and hip joints and in spinal canal stenosis.

Biological, Mechanical or Physical? Conservative Treatment of Cervical Radiculopathy.

BACKGROUND: There is equivocal evidence in support of the effectiveness of each of the three co-existing approaches to conservative treatment of cervical radiculopathy (CR): biological (regenerative), mechanical (decompression) and physical (analgesic and anti-inflammatory). The aim of the study was to compare the effectiveness of the three treatment approaches in CR. MATERIAL AND METHODS: A total of 90 patients were assigned to six treatment groups. Biological treatment: 4 ultra-sound-guided periradicular injections of ACS or PRP (1 per week); Mechanical treatment: manual therapy (MT) or traction therapy (TT) - 8 ses-sions (two per week); Physical treatment: laser therapy (LT) or collagen magnetophoresis (CM) - 8 sessions (two per week). As-sessment: before therapy (W0), after completion of the treatment (W1), two months after completion (W2). Assessment tools: NRS (0-10), NDI (0-50), cross section root area in mm2 in ultrasound examination (CRA) and hand sensorimotor function test (DPT). RESULTS: The largest reduction in mean NRS, NDI and CRA values at W2 was observed with the biological treatments (NRS: ACS 71.7%, PRP 70.6%, NDI: ACS 61.5%, PRP 56.6%, CRA: ACS 23.6 %, PRP 25%). Improvement of hand sensorimotor functions was observed at both W1 and W2 only in the PRP group. The PRP group demonstrated a stronger analgesic effect than the ACS group at W1 (58.82% compared to 43.39%), but ACS therapy had the same effectiveness during the follow-up period. Other methods reduced pain and disability at W1, but further reduction of mean NRS values during the follow-up period was only evident in the CM group (32.25%), very mild in the MM (19.35%) and LT groups (18.75%), and the TT group actually demonstrated a regression (-5.58%). In 3 cases, TT exacerbated the symptoms, which resulted in termination of the therapy. CONCLUSIONS: 1. Biological treatments were more effective than mechanical and physical therapies in reducing pain, im-proving the disability index and proprioception of the hand both immediately on completion of therapy and after a follow-up period, which may suggest their regenerative properties. 2. Physical and mechanical therapies produced improvement in the above-mentioned indicators on completion of the therapy, but subsequently exerted a very slight effect during the follow-up period without evident regenerative effects; moreover, a regression of the results was actually recorded for traction therapy. 3. Caution should be paid when using traction therapy in the acute period of root oedema, due to possible signs of intolerance of the procedure and exacerbation of the discomfort.

Whiplash Injuries. Current State of Knowledge.

Due to the rapid development of transport and a significant increase in the number of road users, whiplash injuries are a global health problem and a significant financial burden for both health care systems and insurance systems. The rich symptomatology of whiplash injuries with their impact on the somatic and emotional-behavioral sphere prompts us to define a new disease entity, namely Whiplash Associated Disorders (WAD). The mechanism of whiplash injury is still under debate and theories explaining the pathogenesis of WAD are very diverse, ranging from purely biomechanical and hydrostatic to neurophysiological, emphasizing sensitization and dysfunctional neuromodulation of pain after whiplash injuries. WAD syndrome should be understood more broadly than just cervical trauma, as problems specific to local legal cultures often determine both epidemiological indicators, the course of treatment and prognosis of the disease. There is a need for further research on the issue of whiplash considering inconsistent literature data about optimal rehabilitation after such injuries.

Collagen Therapy in Lumbar Spondylosis - a Pilot Study. Does the Route of Administration Matter?

BACKGROUND: To compare the effectiveness of three techniques of collagen injection in the treatment of low back pain (LBP) in lumbar spondylosis. MATERIAL AND METHODS: In this randomized prospective study, 30 patients with lumbar spondylosis were assigned to 3 groups: subcutaneous (Group A, n = 10), periradicular (Group B, n = 10) and epidural (Group C, n = 10). Collagen injections were administered once a week (4 injections in total). Assessment involved a visual pain scale (VAS) (0-10), Oswestry scale (0-50), Laitinen scale (0-16) and One Leg Stance Test (OLST) - time to onset of pain in the support limb. Patients were assessed at the start of treatment (W0), on completion of treatment (W1) and 1 month after completion of treatment (W2). RESULTS: Improvement was seen with all three techniques of collagen administration. The minimal clinically important difference (MID) of 3 points on the VAS scale was noted in 44% of patients in Group A, 40% of patients in Group B and 60% of Group C. The MID for the Oswestry scale, determined at 10 points, was achieved in 56%, 50% and 20% of patients, respectively, while the MID for the Laitinen scale, determined at 4 points, was achieved in 56%, 30% and 40% of patients, respectively. All treated patients achieved the reference value of 30 seconds for OLST only in Group A. CONCLUSION: Subcutaneous administration of collagen is not inferior in terms of effectiveness to periradicular and epidural injections in the treatment of LBP in lumbar spondylosis.

Use of Autologous Serum in Treatment of Lumbar Radiculopathy Pain. Pilot Study.

BACKGROUND: The aim of the study was to determine the usefulness of autologous serum in the treatment of patients with signs of radicular compression in the course of lumbar discopathy. The treatment was based on the use of autologous conditioned serum (ACS, Orthokine). MATERIAL AND METHODS: A total of 15 patients with MRI-confirmed single-level nucleus pulposus herniation with signs of radicular compression without paresis in a clinical examination received 6 doses of ACS administered by the same doctor under ultrasound guidance from a posterolateral approach to the area of an intervertebral foramen. The clinical condition of the patients was reassessed at 1 month and 3 months after the administration of the last dose. Pain intensity was assessed with a scoring system and a VAS scale, and radicular oedema was assessed with the following clinical tests: one-leg stance (OLS test) and straight leg raise (SLR test); the disability level was measured with the Oswestry Disability Index. RESULTS: Out of 15 patients, 2 persons had to undergo surgery due to increasing pain. The other subjects showed a statistically significant reduction of pain and clinical signs of radicular compression as well as improved Oswestry scores. No radicular damage following injections or serious complications of the treatment were found. CONCLUSIONS: 1. The Orthokine therapy conducted under ultrasound guidance may be an interesting option in the treatment of compression radiculopathy in the course of radicular compression due to a herniated disc. 2. The present pilot study provides the rationale for studying larger groups of subjects in controlled studies over longer periods of time.