INTRODUCTION

Low back pain (LBP) is increasingly becoming a major public health concern with an estimated global lifetime prevalence of 70–85%.¹ According to the Global Burden of Disease (GBD) 2017, the global years lived with disability (YLD) was 42.5 million (95% UI: 30.2–57.2 million) in 1990 and increased by 52.7% to 64.9 million (95% UI: 46.5–87.4 million) in 2017.² In 2019, the global Low back pain prevalent cases were 568.4 million, with an age-standardized point-prevalence of 6972.5 per 100,000 population, and 223.5 million incidence cases with an age-standardized annual incidence of 2748.9, globally.³In 2019, a systematic review of 13 studies from northern Europe, North America, and Israel reported that the prevalence of LBP ranged between 14% and 20%. Low back pain is now the global leading cause of disability and work absenteeism, associated with huge socioeconomic burden and production loss.

Chronic low back radicular pain (LBP) is a common disorder involving the muscles, nerves, and bones of the back for more than three months. Pain can vary from a sudden sharp feeling to a dull, constant ache. Presentation differs according to the cause, so properly identifying and describing symptoms leads to more accurate diagnoses. Patients complain of a combination or a single symptom of the following: dull pain, referred pain to the buttocks, legs, and feet, and pain worsening after prolonged sitting. Pain that improves within six weeks with or without conservative treatment is considered acute while chronic pain persists for more than three months (7-12 weeks).^4,5

There are no specific characteristics that confirm or ignore the diagnosis of discitis in lower back pain.⁶ More typical features include persistent low back, groin, and/or leg pain. Patients may have experienced prior episodes of acute lower back pain. CLBP may be localized medially, mediolateral, or foraminal in the back. In the physical exam, most of the time there are not any typical characteristics of discogenic pain. Biphasic straightening from flexion is considered by some to be an indication of a disc complaint. Pain that radiates to the toes unilaterally or bilaterally is considered characteristic of discogenic low back pain.

Chronic lower back pain origins may include injury, diseases, or prolonged stress on a specific part of the body. Chronic lower back pain may be classified as radicular or non-radicular according to the lesion place. Mostly associated with spinal nerve root irritation due to compression and inflammation is radicular. Non-radicular is due to abnormalities in facet joints, sacroiliac joints, and intervertebral disks.⁷ In chronic low back radicular pain, it is important to consider conservative treatment (non-surgical). If there was no improvement, the cause must be identified before choosing the most appropriate therapy.

Noninvasive imaging along with a good clinical examination (good history taking and physical exam) should be enough to identify or rule out underlying disease processes (fracture, malignancy, infection, and deformities), neurological disorders requiring surgical intervention (cauda equine syndrome, myelopathy), and psychological distress that may amplify or prolong the pain.⁸ In patients with no neurological demonstrated deficit or a visible disk herniation at imaging, a spinal cause was identifiable in 15%.⁹

Different ways of treatment may be used in the management of chronic lower back pain. They include conservative nonpharmacologic treatment (physiotherapy), and pharmacologic treatment (non-steroidal anti-inflammatory drugs [NSAIDs])  and for those with severe functional disabilities, radicular symptoms, or refractory pain, epidural therapeutic injections or even surgery may be preferred.¹⁰

Patients commonly use conservative treatment options with or without consulting the physician. Nonpharmacologic conservative treatment includes exercise therapy (focusing on strengthening core muscles), behavior therapy (relaxation), and acupuncture massage. Acetaminophen is the first line of therapy because of its high safety profile. NSAIDs may also provide similar analgesia. In patients who did not benefit from either Acetaminophen or NSAIDS, opioids such as tramadol or other adjunctive medications may help.¹⁰

Surgery can be considered in patients with anatomic abnormalities consistent with the distribution of pain and patients with significant functional disabilities not improving even by nonsurgical treatments. Spinal fusion is used in treating back pain caused by fractures.⁷

They include Ozone and PRP injection. Both techniques were found to have benefits for lower back pain.¹¹ Ozone (O3) is an allotropic form of oxygen, primarily known for its ecological properties, industrial application, and therapeutic effects.¹¹ Ozone is given via an injection into the herniated disc. When delivered, Ozone reduces the volume within the disc. This is due to the oxidation of proteoglycans, which are proteins found within the gel-like center of the disc. When the disc volume is reduced, the pressure on nerves is also reduced. This in turn lowers the amount of pain. After many studies of the mixture of oxygen and Ozone gases, the combination was employed in medicine since the thirties in the treatment of different diseases, particularly in patients with thrombotic and ischemic diseases.¹²

The benefit of using this gas mixture in the paravertebral muscles to treat pain has been studied. After many studies, researchers noted that the short-calculated oxidative stress achieved by ozone administration may correct a permanent imbalance caused by excessive or chronic oxidative injury. They discovered that repeated ozone treatment increases the activity of superoxide dismutase, catalase, and glutathione peroxidase, inducing a state of oxidative stress adaptation with major therapeutic implications. The mixture is produced by an apparatus (Ozone generator) that activates the molecules of diatomic oxygen in a voltaic arch.¹³ Ultraviolet spectrophotometry allows precise quantification of Ozone percentages in the mixture obtained.

Every patient will receive local anesthesia before the injection to avoid any pain. Then the patient lies with a pillow under his abdomen to correct lumber lordosis. This maneuver makes the lumber disc area approach to the base of the superior facet of the inferior vertebra, then the neurosurgeon uses a 15 cm long, 22 G spinal needle by directing it into the disc space at an angle of 50-60⁰ approximately. The angle can be obtained by oblique views. When the annulus is reached, the surgeon should twiddle a gritty feel of the annulus. Then the needle is pushed up to the center of the disc (nucleus pulposus) then with verifying the position with anterior, posterior, and lateral imaging. The tip of the needle should be in line with the spinous process and medial to the most medial aspect of the pedicle. The discography is done by using water-soluble contrast to confirm the needle position. When the disc is pathological, the dye spreads all along up to the canal and when the disc is normal, the dye remains in the center. Once confirmed, 5-7cc of 27-40mcg of epidural oxygen-ozone gas is injected into the disc space. The distraction of the space and whitish visualization of gas on the screen confirms the presence of gas in the disc space. The needle is removed, then a sterile dressing of the injection site should be done. The procedure lasts for approximately 20 to 30 mins and the patient is discharged home within two hours.^16-18

Women complain of lower back pain more than men do. This is probably due to their higher responsibilities as workers in addition to spending longer duration in household work and children care.¹⁸ A recently proposed treatment for lumbar disk herniation is percutaneous intra-discal ozone injection. The effectiveness of this treatment has been tested in large clinical studies, findings of which have shown a positive outcome in 70%-80% of patients. In 2005, a study was accomplished by Gallucci et al., to compare the clinical effectiveness of intraforaminal and intradiscal injections of a mixture of a PRP and Ozone versus intraforaminal and intradiscal injections of a PRP and an anesthetic in the management of radicular pain related to acute lumbar disk herniation.¹⁹

One hundred fifty-nine patients (86 men, 73 women; age range, 18-71 years) were included and were randomly assigned to two groups. Seventy-seven patients (group A) underwent intradiscal and intraforaminal injections of aPRP (PLATELET RICH PLASMA)and an anesthetic, and 82 patients (group B) underwent the same treatment with the addition of Ozone. An Oswestry Low back radicular pain Disability Questionnaire was administered before treatment and at several intervals, the last being at a six-month follow-up. Results were compared with the X2 test. The results showed that the intraforaminal and intradiscal injections of a PRP (PLATELET RICH PLASMA)plus Ozone are more effective at six months than injections of only a PRP (PLATELET RICH PLASMA)in the same sites.¹⁹

All patients were evaluated after one month, and those showing only partial success were scheduled for a second treatment session. The study’s results were evaluated with the modified Mac Nab classification, the visual analog scale (VAS), and the Oswestry Disability index at six and 12 months. Success rates were 75% to 80% for soft disc herniation, 70% for multiple disc herniation, and 55% for failed back surgery syndrome. None of the patients suffered early or late neurological or infectious complications. Based on these results, the researchers concluded that minimally invasive percutaneous treatment by Ozone infiltration is a valuable and competitive technique that provides excellent results at low cost and without complications.¹²

This study is to compare the effect of Transforaminal Epidural Ozone and PRP in treatment of low back ache with radiation.

AIM AND OBJECTIVES

In this study, weaim to compare the effectiveness of Transforaminal Epidural Ozone injection [TFEO]and Transforaminal Epidural PLATELET RICH PLASMA[PRP]injection as an alternative treatment modality for patients withchronic low back radicular pain.

Primary Objective:

The primary objective of our study is to determine the efficacy of Transforaminal Epidural Ozone Injection [TFEOI] VsTransforaminal PLATELET RICH PLASMA[PRP]injection in the management of chronic low back radicular pain at 1,3,6 month using VAS Score

Secondary Objectives:

1. To compare the results among male and female patients.

2. To compare complications in both groups.

          3. To compare satisfaction in both group using MCNAB Criteria

MATERIAL AND METHODS

Study settings:

The study will be conducted in the Department of Anesthesiology, King George’s Medical University, Lucknow after getting clearance from the ethical committee, Research Cell, KGMU, Lucknow. 

Study duration:

One year and six months

Study design:

Prospective Randomized Controlstudy 

Sample Size:

It was found that the overall prevalence of pain was 80%. Using this, Sample size (N) was calculated by using following formula:

P =Anticipated population proportion= 70%

Confidence interval =95%

Relative precession. = 5%

Q = Free of disease (100-P)= 30%

Z = Point of normal distribution (as per table of are under normal curve for the given confidence level of 95%) =1.96

e = Allowable error in the estimation = 0.05

Using this formula, sample size was calculated for efficacy of the study participants

Assuming 80% power, 5% significance level with 95% confidence interval and assumed standard deviation being 0.9 as well as absolute error being 0.5,  the total sample size calculated per group is 30.

Expecting 15 % loss on follow up following death or drop-outs, we  included 34 patients in each group.  Therefore, A total of 68 patients were included in the study.

Inclusion criteria: 

·        All Patients giving written informed consent.

·        Patient in the age group of 25 to 70 years.

·        Patients will be clinically diagnosed with Chronic low back radicular pain with confirmed images (MRI) of the spine

·        Patients will be receiving TFEOI (TRANSFORAMINAL EPIDURAL OZONE INJECTION) or TFEPRPI (Transforaminal Epidural Platelet Rich Plasma Injection), with no benefits with conservative treatment  

Exclusion criteria: 

·        Not giving consent

·        Patients with cauda equine syndrome  

·        Patients with ankylosing spondylitis

·        Pregnant women

·        Patients with spinal tumors

·        Patients with congenital musculoskeletal abnormalities

Study Protocol:

Ethical approval and informed consent will be taken.All patients will  diagnosed with Chronic low back radicular pain (7-12 weeks) by clinical symptoms and MRI images are enrolled in study.All patient will be randomly divided into two groups. The patients will be categorized according to the type of presentation of low back radicular pain  and they will be divided into two groups:

Group A: 50%  patients will be treated by transforaminal epidural ozone injection.

Group B: 50% patients will be received transforaminal epidural PRP (PLATELET RICH PLASMA) injection.

DATA COLLECTION:

For each patient, information will be collected regarding their name, age, gender, paresthesia, radiculopathy, presence of numbness, results ofMRI, and whether they received an Ozone or PRP (PLATELET RICH PLASMA)injection and their clinical improvement after injection at one month, three months, and six months. The VAS score for pain and Mac Nab criteria for the assessment ofsatisfaction will be used after the procedure. Each patient received a phone call asking them about their symptoms before and after the injection of ozone and PRP.

VAS SCORE:

VAS (visual analog scale) for pain is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. It’s a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually, 10 cm (100mm) in length, anchored by two verbal descriptors, one for each symptom extreme, “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” score of 10. It is demonstrated in the figure presented in the appendix.

Mac Nab modified Criteria: 

Mac Nab scale is used to determine the outcome assessment of patient satisfaction after ozone or PRP (PLATELET RICH PLASMA) injection therapy. The state of satisfaction will be graded as excellent, good, fair, or bad. The excellent result means that the patient had no complaints and will be able to return to full working capacity. The good result indicates that the patient had full working capacity but slight low back and leg pain. The fair result indicates that the patient does not have normal working capacity; low back and leg pain will be reduced but the patient still required the administration of analgesics. Bad and no improvement results mean that the degree of pain is unchanged or worse.

Data Statistical Analysis:

The SPSS (Version 23.0) program will be used for statistical analysis. Descriptive statistics will be presented as mean, standard deviation, median, minimum, maximum, frequency and ratios. Categorical data will be analyzed using the chi-square test, and continuous data will be analyzed using the student t-test. Spearman’s rank correlation coefficient will be used to determine the association between variables. Significance will be evaluated at a p-value <0.05.

REVIEW OF LITERATURE

Gallucci et al (2007) conducted a study that total 159 patients (86 men, 73 women; age range, 18-71 years) were included and were randomly assigned to two groups. Seventy-seven patients (group A) underwent intradiscal and intraforaminal injections of a PRP (PLATELET RICH PLASMA)and an anesthetic, and 82 patients (group B) underwent the same treatment with the addition of an O(2)-O(3) mixture. Procedures were performed with computed tomographic guidance. An Oswestry Low back radicular pain Disability Questionnaire was administered before treatment and at intervals, the last at 6-month follow-up. Patients and clinicians were blinded as to which treatment was performed. After 6 months, treatment was successful in 36 (47%) patients in group A and in 61 (74%) patients in group B. The difference was significant (P < .01).  Intraforaminal and intradiscal injections of a PRP, an anesthetic, and O(2)-O(3) are more effective at 6 months than injections of only a PRP (PLATELET RICH PLASMA)and an anesthetic in the same sites.

Zhang et al (2013) conducted a study that total 172 consecutive adult patients (92 men, 80 women; age range: 23-59 years) with low back radicular pain and radicular pain were included in this study and were randomly assigned to two groups. 90 patients (group A) underwent intradiscal and intraforaminal injection of oxygen-ozone and 82 patients (group B) received the same treatment with additional injection of 1ml of compound betamethasone. Visual analogue scale (VAS) and the Japanese Orthopedic Association’s evaluation system for lower back pain syndrome (JOA score) were administered before treatment and at 3 weeks, 6 and 12-month follow-up period to evaluate the clinical results.  Satisfactory clinical outcomes were obtained in both groups. The reduction of VAS score from baseline to the end of the study was 7.68 to 2.17 and 7.49 to 2.23 in group A and group B respectively, and there were remarkable improvements of mean JOA score and recovery rate in every follow-up time in both groups. Furthermore, in 3 weeks follow-up the JOA recovery rate of group B is higher than that of group A, which there was significant different, but there were no significant differences between two groups in 6 and 12 months.  Concluded that oxygen-ozone nucleolysis provides excellent pain relief in most herniated disc patients who failed to respond to conservative therapy. And there was no significant statistical difference between treatment of injection of oxygen-ozone combined with PRP and ozone only in the 6 and 12 months follow-up. Therefore, O2-O3 seems to play a role in pain relief, and we suggest the administration of the O2-O3 mixture as a first-choice treatment before recourse to surgery or when surgery is not possible and the addition of epidural PRP infiltration is not required.

Taskaynatan MA  et al (2015) conducted a study that total 80 patients (32 female and 48 male; mean age: 45.8 years [range: 25-65 years]) that received fluoroscopically guided transforaminal epidural PRPinjections for chronic radicular low back pain due to lumbar disc herniation. All of the patients had diagnostic MRI findings and did not respond to conservative treatment. All injections were performed by the same physician at the interventional pain unit of a tertiary hospital. The effectiveness of transforaminal epidural PRP injections was assessed via a standardized telephone questionnaire administered 2 years after the first injection. Mean duration of radicular low back pain was 24.50 ± 18.25 months. Most of the epidural injections were administered at the L5 and S1 levels. The most effective post-injection period was the first 5.11 ± 3.07 months. Mean duration of injection effect was 12.46 ± 7.24 months. The response rate to the epidural PRP injections was 72%. There was negative correlation between the duration of treatment effect and the duration of pre-treatment symptoms. Additionally, clinical improvement of radicular low back pain increased significantly as the duration of pre-treatment symptoms decreased. Based on the present findings, we think that transforaminal epidural PRP injections can be used as an alternative treatment for managing chronic radicular low back pain.

Ozcan S  et al (2018) conducted a study that to determine the effect of intradiscal ozone injection on pain score and satisfaction of patients with low back radicular pain (LBP) secondary to disc herniation. Patients with LBP diagnosed with disc herniation were enrolled in this clinical trial. After prepping and draping the area, intradiscal injection of ozone/oxygen mixture (10 ml, 25μg/ml) was performed under a fluoroscopy guide (c-arm). Pain score and patient satisfaction were assessed prior to the injection (baseline) and 1, 3, 6, 12, and 24 months after the injection. Sixty-three patients (24 males, 39 females) with mean age of 53.3 ±2.0 y enrolled in the study. The mean±standard deviation (SD) of the pain score before intervention was 6.968 ±0.11. Pain score was reduced to 4.25±0.19 at 1 month, 4.33±0.20 at 3 months, 4.87 ±0.21 at 6 months and 5.22 ±0.20 at 24 months. According to the modified MacNab scale success of pain relief was as follows: excellent: 4 (6.3%), good: 17 (26.98 %), sufficient: 13 (20.63 %), poor: 13 (20.63 %), no result: 11 (17.46%), negative: 4 (6.3 %). Intradiscal ozone therapy was determined to provide improved outcomes in patients with a single level of bulging and protrusion.

Xu Z et al (2021) conducted a randomized controlled trial, in ultrasound-guided transforaminal injections of either PRP (PLATELET RICH PLASMA)or Ozone were administered to a total of 124 patients who suffer from radicular pain due to lumbar disc herniation. Patients were assessed by the visual analogue scale (VAS), pressure pain thresholds (PPTs), Oswestry disability index (ODI), and the physical function (PF) and bodily pain (BP) domains of the 36-item short form health survey (SF-36) before operation and 1 week, 1 month, 3 months, 6 months, and 12 months after operation. The rate and latency of F-wave were obtained before operation and 12 months postoperation. There was no statistical difference in terms of age and sex between both groups. Statistically significant improvements from the patients’ data before operation to data obtained 1-month postoperation were observed in VAS, PPTs, ODI, and PF and BP of SF-36 in both groups and kept for 1 year. F-wave rate and latency were improved significantly at 1-year postoperation in both groups. Intergroup differences during follow-ups over a period of 1 year were not found to be significant in all the above assessment between the PRP (PLATELET RICH PLASMA)and Ozone groups. No complications were reported. The results showed similar outcome for both transforaminal injections using PRP (PLATELET RICH PLASMA)and ozone in the treatment of lumbar disc herniation, suggesting the possible application of PRP (PLATELET RICH PLASMA)injection as a safer alternative.

Fathy, W  et al (2022) conducted a randomized controlled trial total 135 patients having symptomatic lumbar disc prolapse, received either transforaminal injection of Magnesium sulphate with PRP, Ozone with PRP, or PRP (PLATELET RICH PLASMA)alone. Assessment of pain severity and functional disability were done before intervention, 2 weeks, 1, 3, and 6 months after intervention. Serum SOD and GSH were measured for all included patients before and 2 weeks after intervention. There was a statistically significant improvement in pain intensity and functional disability 2 weeks after intervention in the three groups, but at 1-month and 3-months after intervention, the significant improvement was in Mg sulphate and Ozone groups only. At 6-months follow up, Mg sulphate group only showed a significant improvement. There was a statistically significant increase in SOD and GSH serum levels, 2-weeks after intervention in both Magnesium sulphate (P-value = 0.002, 0.005 respectively) and ozone groups (P-value < 0.001, < 0.001), but there was no statistically significant change in SOD and GSH serum levels in control group. Transforaminal injection of Mg sulphate in patients with lumbar disc prolapse causes significant long-term improvement (up to 6 months) in pain intensity and functional disability. The serum levels of SOD and GSH were significantly increased at 2 weeks following both transforaminal injection of Mg sulphate and ozone.

Chemeisani A et al (2023) conducted a retrospective study a one-year (2016-2017) total 100 patients with CLBP were selected from two hospitals (Alnajdah, and Ragheb Harb hospitals) and divided into two groups. Fifty patients were treated with Ozone injections while the other 50 were treated with PRP (PLATELET RICH PLASMA)injections. To determine the effectiveness of transformational epidural injection of ozone (TFEOI) in the management of CLBP among the Lebanese population in the Nabatieh area in comparison with patients who received transformational epidural PRP (PLATELET RICH PLASMA)injection (TFESI). For each patient, we recorded the type of pain, irradiation, paresthesia, and the type of injection given (PRP (PLATELET RICH PLASMA)or Ozone). We used the patients’ files and contacted them via phone calls. The results of this study were reached based on Vas Score and Mac Nab criteria which are subjective questionnaires. The study showed that the TFESI was effective for a short duration (86% of results were excellent and good after one month of injection, but they decreased to 16% after six months). On the other hand, TRANSFORAMINAL EPIDURAL OZONE INJECTION was effective over both short and long duration (82% excellent and good after one month, 64% excellent and good after six months). This study provides that ozone injection has high benefits in the management of CLBP in the Lebanese population.

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