+91 9063922599
+91 9063922599
submission@cmegeriatricmed.co.uk
|
FAQs
Introduction: Low back pain (LBP) has the highest prevalence globally among musculoskeletal conditions and is the leading cause of disability worldwide. Intervertebral disc degeneration (IDD) was the most common cause of low back pain. Objective: In this study, we compared the efficacy of the intradiscal PRP injection in relieving pain in patients with discogenic low back pain with the control group receiving only conservative treatment in the form of NSAIDs and muscle relaxants. Therefore, this study was conducted to determine if autologous platelet-rich plasma (PRP) injection into a degenerative intervertebral disc, without Modic changes on magnetic resonance imaging (MRI), improve pain and function. Methods: Patients were randomly divided into 2 groups in this prospective randomized controlled study. The study was conducted in outpatient spine practice at Niazi Medical and Dental College Hospital, Sargodha. Group 1 received Platelets rich plasma therapy whereas Group 2 only received analgesics and muscle relaxants as their treatment option. PRP was injected intradiscally at that specific level under intermittent fluoroscopy. After 6 months, an MRI of the lumbar spine was carried out to see the changes in Modic type I. Assessment of pain by visual analogue scale (VAS) and disability by Roland‐Morris disability questionnaire (RMDQ) was done at different time intervals (pre-injection and post-injection at 1 week, 1 month, 3 months, 6 months, and 12 months). Results: The patient who were in group A received platelet rich plasma showed significant improvement in symptoms including pain and disability, The VAS score decreased from 7/10 to 3/10, and the RMDQ score decreased from 13/24 to 5/24 after the last observation at 12 months. Improvement in quality of life was also observed at 12 months post-injection. A decrease in high signal intensity on T2WI was seen in the follow-up MRI compared to before the PRP injection. Conclusions: In conclusion, intradiscal PRP injection is effective for LBP patients with type 1 Modic change. More prospective studies are needed to establish the safety and efficacy of PRP in type I modic change associated with low back pain.
Chronic low back pain, a common condition that frequently lacks an exact etiology and a specific treatment, is defined as pain between the lowest rib and the upper buttock fold persistent for at least three months1. It is the leading cause of disability worldwide2,3,4. Provocative discography is used to confirm that intervertebral disc is the likely source of pain5. Degenerative changes in the intervertebral disc, a process in which the cartilage dehydrates and the disc height decreases, is often associated with this diagnosis6. Several proinflammatory mediators produced by degenerative discs are believed to cause persistent inflammation of the discs’ nucleus and within the annular tears. Through these annular tears granulation tissue and free nerve endings can grow associated with low back pain.
Degenerative changes may occur in the endplates , which can be seen on an magnetic resonance imaging (MRI) scan as Modic Changes7. There is a positive association between discography and Modic Changes type 1 and 28. There is also increasing evidence that Modic Changes are related to a low grade infection9.
There is no gold standard treatment for discogenic low back pain5, and the options include minimal invasive interventions as well as fusion surgery or total disc replacement as a last resort10. In the last decades, biological treatment modalities like Platelet Rich Plasma (PRP) have evolved11. Growth factors released by these platelets are believed to stimulate healing. Examples of growth factors released by platelets are transforming growth factor beta (TGF-β), insulin-like growth factor (ILGF), platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF). Many of these growth factors play an important role in stimulating duplication, activation and growth of mesenchymal cells, such as osteoblasts, fibroblasts and endothelial cells12. Although several previous studies showed positive effect of PRP for different musculoskeletal disorders, the effect on the intervertebral disc and its clinical outcomes (pain and
functioning) are unclear13.
The intervertebral disc is an avascular structure and as such has low concentrations of growth factors and impaired healing capabilities. Intradiscal injection of PRP is aimed at reducing the degenerative process and to promote healing. PRP contains growth factors and bioactive proteins that influence the healing of tendon, ligament, muscle, and bone14. It was first used in 1987 in autologous transfusion support of cardiac surgery patients and subsequently used for other treatments. PRP is blood derived. It is processed in a way (centrifuging) that high concentration platelets remain in the plasma and it releases growth factors in high concentrations when activated 15,16. A recent RCT showed promising results of PRP injections into a degenerated lumbar disc at eight weeks follow up . No major complications were reported in this trial but one case report described an infection after intradiscal PRP injection17,18. Given the risks involved, it is important to demonstrate effectiveness of PRP in a randomized trial. Thus, the objective of our study was to determine if autologous platelet-rich plasma (PRP) injection into a degenerative intervertebral disc, without Modic changes on magnetic resonance imaging (MRI), improve pain and function compared to control.
Patients were randomly divided into 2 groups in this prospective randomized controlled study. The study was conducted in outpatient spine practice at Niazi Medical and Dental College Hospital, Sargodha. Group 1 received Platelets rich plasma therapy whereas Group 2 only received analgesics and muscle relaxants as their treatment option. PRP was injected intradiscally at that specific level under intermittent fluoroscopy. Inclusion Criteria 1. Age between 18-65 years 2. Pain for atleast 3 months 3. Loss of disc height less than 50 % on MRI Exclusion Criteria 1. Modic changes on MRI 2. Pregnancy 3. Anticoagulants 4. Contrast allergy 5. Severe spinal stenosis 6. Spondylolisthesis Grade 2 or more 7. Radicular symptoms After obtaining informed consent, the patient was taken to the operating theatre. Antibiotics were administered by peripheral venous access to prevent infection before intradiscal PRP injection. PRP was prepared by the pathology department of the same centre from the sample obtained from the same patient . The patient was placed in a prone position on the X-ray operating table, and the L4-5 level was identified by counting vertebrae from X-ray images. With all aseptic precautions, the skin was infiltrated with 1% lignocaine. Then, a spinal needle (22-gauge, 150mm) was inserted into the nucleus pulposus (NP) of the L4/5 disc in the anteroposterior (AP) and lateral views under intermittent fluoroscopy. Approximately 2 mL of PRP was slowly injected through a syringe into the disc. After the procedure, the patients were observed in the post-operative ward for about an hour for any complication. The patient was advised to do activities of daily living and physical activity, such as exercise, at 7 days and 1 month postinjection, respectively. They were also advised not to take steroids and non-steroidal anti-inflammatory drugs (NSAIDs) for about 1 month, except in the case of particularly severe pain (VAS scores of 8 points or more). Follow-up surveys, including VAS, RMDQ, and any side effects, were carried out at 1 week, 1 month, 3 months, 6 months, and 12 months interval following intradiscal PRP injections. Quality of life by SF-12 was measured after 1 month, 6 months, and 12 months. Subsequently, a follow-up MRI of the lumbar spine was done after 6 months of injection. Fig: MRI shows Modic changes at L4/5 Fig. Xrays of a patient with L4/5 Disc changes Flouroscopic view of PRP injection technique Outcome measures The primary outcome measures were changes in pain as measured with the Numeric Rating Scale (NRS), and changes in disability as measured with the Roland Morris Disability Questionnaire (RMDQ). Secondary outcome measures were changes in self-reported mental and physical health as measured with SF-12. These measurements were applied before the intervention (index) and at one year follow up. Measurement were repeated at 1 week, 4 weeks, 2, 4, 6 and 9 months as secondary time points. To blind the outcome measurements, the research nurse and the patient were not informed about the preparations injected. Statistical analysis A minimally clinical important change for pain was defined 2 points on the NRS scale, and for functioning 3 points on the RMDQ . Based on a previous RCT decrease in pain to NRS 5 from 7 and decrease in disability to RMDQ 9 from 12 points was expected after 9 and 12 months. To detect this difference with the two-sample t-test at 90% power and p < 0.05, approximately 80 participants (40 per group) were required . Allowing for 20% drop out we intended to recruit 100 participants. NRS pain score for average and worst pain, and functionality score as measured with RMDQ of both groups are continuous variables. Quantitative analysis was performed on these primary outcome measures. Secondary outcome measures were self-reported physical and mental health measured with SF-12. Differences in outcome were measured at 1 week, 1,2,4,6,9 and 12 months.
Figure 2 shows the VAS score and RMDQ score after PRP injections at different points in time (lower scores indicate better). VAS score was reduced from 7 to 3 after 3 months, and no further reduction was observed at the last observation after 12 months. RMDQ score also decreased from 13 to 5 after 6 months and remained the same at 12 months.
Intervertebral discs (IVDs) and vertebral subchondral bone (VSB) are important anatomical elements of the spinal column affected by pain and degenerative pathology19. Indeed, the whole can be considered as an intervertebral joint functional unit, composed of an IVD, the upper and lower vertebrae, and the facet joints20. In adults, an endplate bilayer of cartilage and bone (VSB) is located at the ends of each IVD, separating the vertebral bone from the IVD itself and preventing the central, gel-like, hydrated nucleus pulposus from bulging outward into the neighboring spinal canal and nerves. It is known that the VSB plays an important role in spinal function, maintaining IVD integrity and disc nutritional supply. Changes in IVD and VSB biomechanical and biochemical properties are associated with the development of back pain and degenerative disc disease (DDD). Some structural VSB alterations have been linked to disc degeneration21. The prevalence of diagnosed spinal degenerative disease increases with age, is more common in females than in males, and is greater with obesity 22,23. With osteopenia, bones are more likely to become sore from a lack of support, which can lead to back pain. On the other hand, chronic low back pain increases disability and has an increased incidence of osteopenia and osteoporosis24. Our patient belongs to an older age group, female, and obese, which may influence the risk of MC with low back pain. In a prospective cohort study 25,26. The authors concluded that Modic type I was the only degenerative finding that predicted persistent symptoms. Mitra et al. found a trend of higher pain intensity and disability scores among patients with Modic type I component and lower scores in patients with conversion of Modic type I to II27. Treatment of Modic type I is still controversial, with some reports showing that antimicrobial agents are effective, whereas others reported that they were ineffective28. In recent years, PRP therapy has been one of the regenerative medicines that has been attracting attention. A variety of growth factors, coagulation factors, adhesion molecules, cytokines, chemokines, and integrins are stored in platelets5,11. The growth factors released by platelets include transforming growth factor (TGF) β-1, vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and epidermal growth factor (EGF); therefore, PRP injection in an IVD may result in cellular and tissue proliferation3,5,1128. This case study showed the effect of a single intradiscal autologous PRP injection in a patient with Modic change. The findings demonstrated clinically significant improvements in pain, physical function, and quality of life at several time points compared to baseline. Kawabata et al. successfully demonstrated the efficacy of intradiscal administration of PRP in patients with Modic type I28. They followed up with 10 patients after intradiscal PRP for up to 24 weeks and found significant improvement in the VAS, Oswestry disability index (ODI), and RMDQ. A prospective clinical trial on intradiscal platelet-rich plasma injection for discogenic LBP was conducted by Jain D et al. demonstrated improvement of the numeric rating scale (NRS) and ODI score after PRP therapy3. Another study evaluating the effectiveness of autologous PRP on discogenic low back pain (DLBP) at 48 weeks postinjection revealed a significant reduction of pain score (NRS) and improvement of SF-36 score29. In our study, we followed up for 12 months and found a clinically significant reduction of VAS and RMDQ scores as well as an improvement in SF-12 scores. The process of Modic change in our patient was somehow reversed by PRP injection. This autologous platelet-rich plasma mimics the physiological repair process by releasing autologous growth factors (GFs) and creating a transient biological matrix. It can be considered that PRP treatment could stimulate the endogenous repair machinery and induce the healing of damaged spinal components to ultimately restore disc and vertebral bone homeostasis and an improvement in the functional anatomy of the end plate21. It is difficult to determine whether Modic type 1 is the cause of LBP. Discography may be necessary to diagnose Modic change accurately as the cause of LBP. However, discography, an invasive test, was not performed in this study because a significant association was established between MC and LBP28. Only a few reports demonstrate MRI improvements in disc degeneration and Modic change after PRP treatment. As MRI provides more detailed information, the case presented here shows appreciable MRI improvements in terms of decreasing high-signal intensity on T2WI after 6 months of PRP therapy21,28. Other modalities like intradiscal steroid injections, anti-tumor necrosis factor (TNF)-α antibodies, and antibiotic administration, have been reported to have short-term efficacy in Modic change, but long-term results are unknown. Albert et al. treated patients with Modic type I with antibiotics for 100 days and reported that the VAS of patients with LBP improved from 67 to 37 mm after 1 year29.
Intradiscal injection of PRP can relieve pain and improve lumbar function as well as quality of life in patients with LBP associated with Modic changes of IV disc. It also promotes morphological changes of Modic type I, which is demonstrated with MRI analysis. Further randomized controlled clinical trials are needed to evaluate the safety and efficacy of this injection therapy for LBP with Modic changes .
Download
Download
Download
Download
Download XML
