Translate this page into:
Comparative efficacy of low-vs high-volume caudal epidural steroid injections in lumbar degenerative disc disease: A systematic review protocol
⁎Corresponding author: Vinish V. vinish.v@manipal.edu
-
Received: ,
Accepted: ,
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.
Abstract
Abstract
Lumbar degenerative disc disease (LDDD) is a progressive disorder caused by intervertebral disc dehydration followed by an annulus fibrosis tear, which causes inflammation. As this process progresses, it can cause the loss of disc height, pain, neurological symptoms, and mechanical instability due to the loss of disc height. The prevalence of LDDD increases with age and is a significant contributor to disability and reduced quality of life worldwide.
The major aim of this systematic study is to determine the effectiveness of caudal epidural steroid injection (CESI) in the treatment of lumbar degenerative disc disease (LDDD).
The literature search will do in articles published in the last 20 years (1 January 2004 to 31 December 2024) those published in the English language. For articles published in other languages, English translations were sought if available. A comprehensive search of academic databases such as Scopus, PubMed, Embase, Cochrane and Web of Science using appropriate keywords and Boolean operators will be performed. The present systematic review used a three-phase search strategy. MEDLINE and CINAHL will be searched in the first phase, and the words in the abstract and title as well as the index terms used to describe the article will be analyzed. In the second stage, every recognized keyword and index term is used. The third stage of the literature search was looking for more research in the reference lists of the papers that were found.
The anticipated impact includes guiding clinical decision-making, optimizing CESI protocols, informing guidelines, and identifying evidence gaps for future research in LDDD management.
Keywords
Pain relief
Functional improvement
Good health and wellbeing
Quality of life
Adverse events
1 Introduction
Lumbar degenerative disc disease (LDDD) is a common cause of chronic low back pain, functional impairment and disability.
It is a progressive disorder caused by intervertebral disc dehydration followed by an annulus fibrosis tear, which causes inflammation. As this process progresses, it can cause the loss of disc height, pain, neurological symptoms, and mechanical instability due to the loss of disc height. The prevalence of LDDD increases with age and is a significant contributor to disability and reduced quality of life worldwide.1,2
Caudal epidural steroid injection (CESI) is a globally used minimally invasive procedure that reduces pain by reducing the inflammatory cascade in disc degeneration. This technique involves delivering corticosteroids and normal saline into the epidural space via the sacral hiatus. CESI is commonly employed for patients with low backache, radicular pain, failed conservative treatments, or as a bridge to surgical interventions.3Despite its worldwide use, the efficacy of CESI remains a topic of debate. Numerous studies have investigated the role of CESI in providing pain relief and functional improvement. However, many of the results have been inconsistent. Some studies report significant short-term benefits, whereas others indicate only modest or transient effects.4,5 Overall, the concept of the optimal volume of injectate—low-volume versus high-volume CESI—remains unclear. Although high-volume CESI (more than 10 ml) logically offers more extensive drug dispersion to higher levels of the lumbar disc and long-lasting pain relief, concerns exist regarding increased risks of complications such as an immediate increase in painful dural puncture, hypotension and syncopial attack.
This systematic review aimed to assess the efficacy of CESI in patients with LDDD, comparing pain relief, functional outcomes, and the incidence of adverse effects between low-volume and high-volume injections. By synthesizing current evidence, this review seeks to provide clinical insights into the benefits and risks of CESI in LDDD management and guide best practices for its application.
2 Purpose of this review
Conducting a systematic review on the efficacy of caudal epidural steroid injections (CESIs) in managing lumbar degenerative disc disease (LDDD) is essential for several reasons.1.Clarifying Inconsistent Findings: Existing studies on CESIs for LDDD have yielded mixed results. Some studies indicate short-term pain relief, whereas others suggest limited long-term benefits. A systematic review can synthesize these findings to better understand the effectiveness of CESI.2.Guiding Clinical Practice: Healthcare professionals require consolidated evidence to make informed decisions about the use of CESIs. A comprehensive review can offer insights into when and for whom CESIs are most beneficial, aiding in personalized treatment planning.3.Evaluating Safety and Risks: Understanding the potential complications associated with CESIs, such as infection or nerve damage, is crucial. A systematic review can assess the incidence of adverse events, helping practitioners weigh the benefits against the risks.4.Informing Policy and Guidelines: Health organizations and policymakers rely on robust evidence to develop guidelines. A systematic review can contribute to standardized protocols, ensuring consistent and effective patient care.5.Identifying Research Gaps: By consolidating literature, a systematic review can highlight areas where evidence is lacking, directing future research efforts to address unanswered questions.
2.1 Objective of the systematic review
Determining the effectiveness of caudal epidural steroid injection (CESI) in the treatment of lumbar degenerative disc disease (LDDD) is the major aim of this systematic study.
3 Novelty of the study
The primary aim of this study is to generate new clinical insights specifically regarding the impact of injectable volume on both efficacy and safety. The novelty lies in systematically comparing low-volume versus high-volume caudal epidural steroid injections (CESI) using the same steroid dose, which enables us to isolate and evaluate the effect of volume alone—a variable that remains inadequately studied despite its widespread clinical relevance.
In addition to assessing pain relief and functional outcomes, the study uniquely focuses on the comparative analysis of complications, particularly those associated with high-volume injections. Existing evidence and our pilot study suggest that higher volumes may increase the risk of adverse effects such as post-injection pain, vasovagal attacks, insomnia, and cardiovascular responses (e.g., tachycardia and hypertension), likely due to dural and neural tissue stretch. Our trial is designed to quantify these complications and determine whether low-volume CESI can achieve similar or better efficacy with fewer adverse events, ultimately supporting a safer and more cost-effective approach to managing lumbar degenerative disc disease.
Protocol registration
The review study results will be reported under the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) standards. With the ID CRD42025639150, this systematic review was entered into the PROSPERO database (prospectively registered systematic reviews in health and social care).
4.1 Research questions
1)What is the efficacy of CESI (compared to placebo or no intervention) in improving pain and function in patients with LDDD?2)How does high-volume CESI compare to low-volume in terms of duration and magnitude of pain relief?3)Do low-volume and high-volume CESI have different rates of problems or adverse events in the effect?
4.1.1 Source review
The literature search aims to identify published research papers, restricted to those published in the English language. For articles published in other languages, English translations were sought if available. The present systematic review used a three-phase search strategy. MEDLINE and CINAHL will be searched in the first phase, and the words in the abstract and title as well as the index terms used to describe the article will be analyzed. In the second stage, every recognized keyword and index term is used. The third stage of the literature search was looking for more research in the reference lists of the papers that were found. Gray literature will be searched using a combination of broad keyword queries and Boolean operators tailored to each platform. We will document the search terms, filters applied (e.g., date, language), and the number of records retrieved.
4.2 Search strategies
A comprehensive search of academic databases such as Scopus, PubMed, Embase, Cochrane and Web of Science using appropriate keywords and Boolean operators will be performed. Google Scholar will be used to search for gray literature relevant to the study. Details presented in Tables 1 and 2.⮚Articles published in the last 20 years (January 1, 2004 to December 31, 2024) should be included to ensure the relevance of the study.⮚Gray literature and unpublished studies were considered to minimize publication bias.➢Contact study authors for missing information/data.⮚Manual searches will be carried out on different websites related to CESI and LDDD.⮚Searches should be updated before the final analysis⮚Use of a citation manager to organize the results from all searches and provide an accurate reference list
| Keywords | MeSH terms |
| Concept 1:Caudal epidural steroid injection | caudal[tw] OR epidural[tw] OR steroid∗[tw] OR injection∗[tw] OR "epidural space"[MeSH Terms]OR "injections"[MeSH Terms] OR "injections"[MeSH Terms] |
| Concept 2:Lumbar degenerative disc disease | lumbar[tw] OR “degenerative disc disease”[tw] OR “lumbar vertebrae”[tw] OR "lumbosacral region"[MeSH Terms] OR "Intervertebral Disc Degeneration"[MeSH] OR "lumbar vertebrae"[MeSH Terms] |
| Concept 3:Efficacy | “effectiveness of treatment”[tw] OR effectiveness∗[tw] OR “clinical outcome∗”[tw]OR “therapeutic effect∗”[tw] OR “pain relief”[tw] OR "treatment outcome∗"[MeSH Terms] OR "therapeutics"[MeSH Terms] OR "clinical trials as topic"[MeSH Terms] |
| Sl No | Search strategy | No of Hits |
| #1 | caudal[tw] OR epidural[tw] OR steroida[tw] OR injectiona[tw] OR "epidural space"[MeSH Terms]OR "injections"[MeSH Terms] OR "injections"[MeSH Terms] | 100,290 |
| #2 | lumbar[tw] OR "degenerative disc disease"[tw] OR "lumbar vertebrae"[tw] OR "lumbosacral region"[MeSH Terms] OR "Intervertebral Disc Degeneration"[MeSH] OR "lumbar vertebrae"[MeSH Terms] | 17,556 |
| #3 | "effectiveness of treatment"[tw] OR effectivenessa[tw] OR "clinical outcomea"[tw]OR "therapeutic effecta"[tw] OR "pain relief"[tw] OR "treatment outcomea"[MeSH Terms] OR "therapeutics"[MeSH Terms] OR "clinical trials as topic"[MeSH Terms] | 852,772 |
| #4 | #3 AND #2 AND 3# | 1713 |
4.3 PICO
4.3.1 Population
●Studies included adults (18 years–60) with a diagnosis of lower lumbar degenerative disc disease (L4–L5 and L5–S1) as diagnosed by MRI, with clinical signs and symptoms consistent with disc herniation and failure of conservative treatment for at least 6 weeks.●Male, female and nonbinary individuals from diverse demographic backgrounds were included.
Caudal epidural steroid injection (CESI) is a minimally invasive procedure used to manage pain associated with conditions such as lumbar degenerative disc disease. In this technique, a corticosteroid (anti-inflammatory medication) and sometimes a local anesthetic are injected into the epidural space through the sacral hiatus at the base of the spine. Caudal epidural steroid injection (CESI) is a minimally invasive procedure used to manage pain associated with conditions such as lumbar degenerative disc disease. In this technique, a corticosteroid (anti-inflammatory medication) and sometimes a local anesthetic are injected into the epidural space through the sacral hiatus at the base of the spine. In this study, low-volume CESI is defined as 5 ml total volume (2 ml triamcinolone [80 mg] + 3 ml normal saline), and high-volume CESI is defined as 12 ml total volume (2 ml triamcinolone [80 mg] + 10 ml normal saline).
4.3.2 Comparison
Placebo, the current protocol does not address how placebo, sham, or conservative treatments (like physiotherapy or oral medications alone) would be handled in subgroup or sensitivity analyses—mainly because such comparators are not part of the study design. This is a two-arm randomized superiority trial directly comparing low-volume versus high-volume caudal epidural steroid injections (CESI). No third arm involving placebo, sham, or conservative treatment is included.
Outcomes: Pain relief, functional improvement, quality of life, and adverse events.
4.4 Study design
Experimental and comparative studies.
4.5 Language
Studies published in the English language globally or if translations are available will be included.
4.6 Exclusion criteria
Studies with controversial results and not including clear interventions were excluded.
Patients with spinal infections, malignancy, previous spinal surgery, facet syndrome, or other confounding pathologies are excluded to maintain diagnostic homogeneity and ensure that the outcomes are attributable solely to LDDD.
4.7 Participants
Studies including patients with conditions other than LDDD, such as spine infections, malignancies affecting the lumbar spine, or fractures in the lumbar region, were included.
Pediatric populations (under 18 years) and elderly populations over 60 years of age are excluded, to minimize the confounding effects of age-related comorbidities such as osteoporosis, spinal stenosis, and facet arthropathy, which are more common in older adults and can independently influence both symptom severity and response to epidural steroid injections. By focusing on a relatively younger cohort, we aim to obtain a more homogeneous study population, thereby enhancing internal validity.
4.8 Interventions
Studies evaluating interventions other than CESI (e.g., transforaminal or interlaminar epidural injections without differentiation)
Studies using CESI for conditions other than LDDD, such as sciatica caused by nondegenerative factors.
4.9 Comparison
Studies without a valid comparator or control group.
4.10 Outcome
Studies that did not report pain reduction or functional improvement as outcomes.
4.11 Conditions or domain being studied
Caudal epidural steroid injection (CESI) is a minimally invasive procedure used to manage pain associated with conditions such as lumbar degenerative disc disease. In this technique, a corticosteroid (anti-inflammatory medication) and sometimes a local anesthetic are injected into the epidural space through the sacral hiatus at the base of the spine. In this study, low-volume CESI is defined as 5 ml total volume (2 ml triamcinolone [80 mg] + 3 ml normal saline), and high-volume CESI is defined as 12 ml total volume (2 ml triamcinolone [80 mg] + 10 ml normal saline). These thresholds were chosen based on both prevailing clinical practices and supportive data from previous literature, including our own pilot study.
We acknowledge the importance of aligning with standardised definitions and will explicitly cite and reference volume categories as discussed by Rabinovitch et al. (2009), who identified <10 ml as low-volume and ≥10 ml as high-volume in their systematic review. Our selected thresholds are therefore consistent with this categorisation and align with their findings on the relationship between volume and clinical outcomes.
4.12 Main outcome(s)
Pain relief, functional improvement, quality of life, and adverse events.
5 Additional outcome(s)
5.1 Data extraction (selection and coding)
The screening and coding process of the systematic review will follow PRISMA guidelines (citation). All the articles related to this review will be downloaded from the abovementioned databases into Zotero, and all the duplicates will be removed immediately. The titles and abstracts will be independently screened for appropriateness per the inclusion and exclusion criteria by 2 research team members, and all the articles found to be appropriate per the criteria at this stage will be included in the review by using COVIDENCE/RAYYAN. Cohen's kappa will be used to assess the inter-rater reliability or agreement between two reviewers during the study selection, data extraction, or quality assessment phases.
In the event of inconsistencies, a third reviewer will answer calls. If the third researcher's disputes persist, the fourth researcher will be consulted, and his decision will be finalized. Data extraction will be based on title, authors, publication year, country, study design, sample size, demographic profiles of the participants, recruitment method, control conditions, data acquisition timing, outcome measures, outcome data, and limitations of the study.
5.2 Risk of bias (quality) assessment
The quality of the selected studies will be assessed via Cochrane tools and other appropriate frameworks on the basis of their study designs. Studies will be scrutinized for participant recruitment methods, control of confounding variables, exposure details, data completeness, blinding procedures, and selective outcome reporting. For RCTs and other study designs, tools such as the Critical Appraisal Skills Programme (CASP) and Joanna Briggs Institute (JBI) will be employed to assess methodological rigor, credibility of the data, relevance of findings, and transparency in reporting.
5.3 Data synthesis
A narrative synthesis of the findings will be performed to group them according to identified factors. A meta-analysis of the findings will be considered if feasible and appropriate based on the study results (see Fig. 1).
5.4 Data analysis
For considering both within-study and between-study variations, specific RR (relative risk) estimates will be combined by using a random-effects model. Egger's linear regression test and Begg's funnel plot will be used to evaluate potential publication bias (Schultz T, 2007). Statistical analysis of these tests and meta-analysis will be performed by using statistical software(s) and by consulting a statistician.
5.5 Analysis of subgroups or subsets
Subgroup analysis will be carried out based on the outcome and study design.
Results on 15/01/25,9.29 p.m.Role of researchersReseacher 1Researcher 2Researcher 3Researcher 4Researcher 5Literature Search✓✓Abstract and Title Review✓✓Full Text Retrieval✓✓Full Text Review and Quality Check✓✓√ (Disagreements will be resolved by discussion and consensus or by consulting a fourth researcher)✓Data Extraction✓✓✓✓
6 Discussion
Caudal epidural steroid injections (CESIs) are a broadly accepted minimally invasive treatment modality for lumbar degenerative disc disease (LDDD), a most important contributor of chronic low back pain and disability. The caudal approach, involving injection through the sacral hiatus, provides great benefits over interlaminar and transforaminal routes, including a decreased risk of dural puncture, less radiation exposure, and wider cranial spread of injectate3,6 The mechanism of CESI relies on administering corticosteroids directly into the epidural space, attenuating inflammation by inhibiting phospholipase A2 activity and suppressing cytokine-mediated nerve root irritation.7
In addition to steroids, injectates often include local anesthetics (e.g., bupivacaine), clonidine, or hyaluronidase to prolong analgesia and improve drug dispersion.8 Recent studies suggest that high-volume CESI (≥10 mL) may enhance cranial spread and decompression effects, potentially improving outcomes in multilevel degenerative pathology.9 However, high volumes may also increase risks such as elevated epidural pressure, transient hypotension, and vasovagal responses.10 Therefore, determining the optimal volume is crucial for maximizing efficacy while minimizing complications.
This systematic review employs a rigorous design aligned with PRISMA and PROSPERO standards to consolidate heterogeneous findings and compare low-versus high-volume CESI outcomes. Experimental and comparative study designs were chosen to minimize bias and facilitate quantitative synthesis. The anticipated impact includes guiding clinical decision-making, optimizing CESI protocols, informing guidelines, and identifying evidence gaps for future research in LDDD management.
7 Conclusion
In conclusion, it is essential to conduct a systematic review on CESIs in LDDD to consolidate existing knowledge, guide clinical decisions, assure patient safety, and clarify the duration of benefit, safety concerns, and dosage optimization between high- and low-volume CESI for LDDD.
CRediT authorship contribution statement
Raju Karuppal: Prepared manuscript. Vinish V: Prepared and edited the manuscript. Jyothi Chakrabarty: Corrected the manuscript. Sooraj K: Prepared manuscript. Pratiba Takur: Prepared manuscript.
Patients consent
Patient's Consent is not required for this study as there is no direct data is collected from the participants.
Ethical statement
Ethical permission is obtained from the institution. No preaching of data happened in the study.
Utmost care is taken to follow the research ethics.
Funding statement
This study is not funded by any organization. The expenditure is met by the researchers themselves.
References
- Nomenclature and classification of lumbar disc pathology. Spine. 2001 Mar 1;26(5):461-462.
- [Google Scholar]
- Prevalence and distribution of intervertebral disc degeneration over the entire spine in a population-based cohort: the Wakayama Spine study. Osteoarthr Cartil. 2014 Jan 1;22(1):104-110.
- [Google Scholar]
- Evaluation of the effectiveness of lumbar interlaminar epidural injections in managing chronic pain of lumbar disc herniation or radiculitis: a randomized, double-blind, controlled trial. Pain Phys. 2010;13(4):343.
- [Google Scholar]
- A multicentre randomized controlled trial of epidural corticosteroid injections for sciatica: the WEST study. Rheumatology. 2005 Nov 1;44(11):1399-1406.
- [Google Scholar]
- Effect of caudal epidural steroid or saline injection in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trial. BMJ (Pract Obs Ed) 2011 Sep 13:343.
- [Google Scholar]
- Predictive factors of the effectiveness of caudal epidural steroid injections in managing patients with chronic low back pain and radiculopathy. Clin Spine Surg. 2017 Jul 1;30(6):E833-E838.
- [Google Scholar]
- Epidural steroids: a comprehensive, evidence-based review. Reg Anesth Pain Med. 2013 May 1;38(3):175-200.
- [Google Scholar]
- Caudal epidural steroid injection in the treatment of chronic discogenic low back pain. Comparative, prospective and randomized study. Rev Española Cirugía Ortopédica Traumatol. 2013 Sep 1;57(5):324-332.
- [Google Scholar]
- Complications of interventional pain management procedures. Adv Anesth. 2008 Oct 1;26:1-30.
- [Google Scholar]