Randomised control trial of epidural platelet rich plasma versus epidural steroids for low back pain

Adarsh Jayasoorya T.; Nitin Samal

doi:10.12688/f1000research.139399.1

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Study Protocol

Randomised control trial of epidural platelet rich plasma versus epidural steroids for low back pain

[version 1; peer review: 1 approved with reservations]

Adarsh Jayasoorya T.¹, Nitin Samal²

PUBLISHED 26 Sep 2023

Author details Author details

¹ Department of orthopaedics, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India
² Department of orthopedics, Datta Meghe Institute of Higher Education and Research, wardha, Maharashtra, 442001, India

Adarsh Jayasoorya T.
Roles: Data Curation, Formal Analysis, Investigation, Methodology, Resources, Software, Supervision, Visualization

Nitin Samal
Roles: Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background: Lower back pain (LBP) is a prevalent medical condition that frequently results in work-related disability and is one of the leading causes of missed workdays. Low back pain (LBP) struck 619 million people worldwide in 2020, and by 2050, it's predicted that there will be 843 million instances worldwide. 70 to 85% of people are predicted to suffer from LBP at some point of time in their lives. 90% of these people will experience multiple episodes, and an intervertebral disc prolapse accounts for a significant portion. Medications and lifestyle adjustments may be used as the first line of treatment. However, if the symptoms do not improve, minimally invasive procedures such as epidural steroid injection and epidural platelet-rich plasma injection may relieve the pain and lessen disability. We therefore aim to conduct a study to analyse the patient’s functional status and satisfaction after epidural platelet-rich plasma infiltration.
Methods: Eligible patients with low back pain will be divided into two groups(Group A and Group B). Patients in group A will receive epidural steroid whereas Group B will receive epidural Platelet rich plasma. These patients will be monitored where visual analogue scale will be used to assess relief of pain before and after the procedure, Straight leg raising test will be used to understand the improvement of the patient clinically during examination pre and post procedure. Oswestry disability index will be used to compare the outcome in patient's day to day activities before and after the intervention. Patients will be evaluated with these methods pre-procedure and 1 hour after and later follow up evaluation will be done after 3 weeks and 3 months. The follow-up scores will be taken post one hour, three weeks and three months of the treatment.
Protocol version: v1 dated 04/07/23
CTRI registration: REF/2023/06/068736 (12/06/2023)

Keywords

Low back pain, Platelet rich plasma, epidural PRP, Outcome analysis.

Corresponding author: Adarsh Jayasoorya T.

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2023 Jayasoorya T. A and Samal N. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Jayasoorya T. A and Samal N. Randomised control trial of epidural platelet rich plasma versus epidural steroids for low back pain [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:1221 (https://doi.org/10.12688/f1000research.139399.1) First published: 26 Sep 2023, 12:1221 (https://doi.org/10.12688/f1000research.139399.1) Latest published: 26 Sep 2023, 12:1221 (https://doi.org/10.12688/f1000research.139399.1)

Introduction

One of the primary causes of lost workdays and a common medical ailment, low back pain (LBP), usually leads to work-related incapacity.¹ Low back pain (LBP) is a multifactorial and the most prevalent musculoskeletal disorder, whose economic burden is of global concern.² One of the most prevalent spinal degenerative disorder, lumbar disc herniation can cause radicular leg pain and low back pain (LBP).³ If lifestyle modifications and medication are inadequate, minimally invasive techniques, such as epidural steroid and platelet-rich plasma, may be used to manage the symptoms and lessen disability.

LBP is described as pain that begins in the back and radiates to the legs. It is also known as sciatica, lumbar radiculopathy, or nerve root irritation Pathophysiological changes on intervertebral discs can lead to disc herniation, degenerative changes including canal stenosis, or chronic instability of the afflicted segments.⁴ According to some estimations, lumbar disc herniation is estimated to be the root cause of sciatica, which means that 90% of all cases of sciatica that have been reported have this problem.⁵ Treatment of this condition varies from conservative to surgical options.⁶ There are several nonsurgical treatments for low back pain, including oral or local analgesics, exercises, diet modification, and Physiotherapy; these conservative treatment modalities aim to delay or prevent surgery. In reality, conservative therapy or self- care can help LBP. Patients resistant to conservative managements are candidates for surgical management.

Acute non-specific low back pain is defined as any pain lasting less than 6 weeks, subacute LBA is defined as lasting between 6 weeks - 3 months, and chronic pain is defined as lasting more than this. Pain is frequently the outcome of aberrant vertebral body motion or caused by instability at a specific motion segment. The loss of the spine's capacity to maintain the relationships between the vertebrae necessary to prevent injury to the spinal cord or irritation of the nerve roots, as well as the emergence of deformity or pain, is known as lumbar spinal instability.

The architecture of the intervertebral discs, which act as cushion between vertebrae and provide stability, flexibility, and some load-sharing, is disrupted in lumbar disc disease.⁴ This may result in a disc herniation that leads to pressure on the spinal cord, causing radiating pain and localized weakness.⁴ A 95 percent likelihood of herniated discs at L4-L5 or L5-S1 occurs in patients between 25 and 55 of age, causing compression at L4, L5, or S1 nerve root.⁶

Scope

Bhatia R and Chopra G suggested that there is a definitive role for PRP via lumbar epidural injection for chronic prolapsed intervertebral disc patients.⁷

Akeda et al administered PRP into the lumbar discs of patients suffering from chronic low back pain and Degenerative Disc Disease affecting one or more lumbar segments. Notably, there was a significant improvement observed in VAS scores, decreasing from 7.1±1.2 to 1.8±2.0 (p<0.01), and this improvement persisted for a duration of 6 months.⁸

As per Bodor et al., positive outcomes were documented following a single intradiscal PRP treatment, and these benefits endured for a span of 6 to 12 months in approximately two-thirds of the patients. Among these patients, half exhibited an “excellent” response, while the other half experienced a “good” response, as determined by pain resolution and the ability to resume their daily activities and exercise routines.⁹

Epidural steroid injection is a non-surgical treatment for managing lower back ache caused by herniated inter vertebral disc or degenerative changes in the vertebrae, which will relieve pain, improve function, and improve quality of life,¹⁰ whereas, Platelet-rich plasma (P.R.P.) is an emerging treatment modality that presents a unique opportunity for patients with the prolapsed intervertebral disc as it can bring down the symptoms and disabilities of the patient.⁷ P.R.P. has been used to improve both hard-tissue and soft-tissue healing. Hence a comparative study will help us to determine the potential of each treatment.

Objectives

• To compare the clinical outcome of chronic intervertebral disc prolapse in lumbar spine managed with epidural platelet rich plasma v/s epidural steroids.
• To assess pain relief using visual analogue scale (VAS)
• To assess relief in functional disability using Oswestry Disability Index (ODI)

Protocol

Study design

This is a prospective randomized control study. The study will involve 64 participants during a duration of July 2023 to May 2024. (Figure 1) This protocol is reported in line with SPIRIT guidelines.¹¹

Figure 1. Flow chart showing study design.

Ethical considerations

The Ethics and screening Committee has approved the research proposal on 18/07/2022 Jawaharlal Nehru Medical College (JNMC), Datta Meghe Institute of Higher Education and Research (Ref.no. DMIMS (DU)/IEC/2022/47), to be carried out at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, Wardha. Prior to their involvement in the study, each participants will receive a thorough explanation of the research’s objectives and procedures from a member of the research team. The participants have the right to withdraw at any time of the study and for any reason without any consequences. Written informed consent will be obtained from all participants to ensure their understanding and voluntary participation in the research. Ethics approval Ref. No. DMIMS (DU)/IEC/2022/47 dated 18/07/2022. This study has been registered at CTRI (REF/2023/06/068736) on 12/06/2023.

Participants

Inclusion criteria

All Skeletally matured patients between the age of 18 – 70 years.

Diagnosed cases of lumbar intervertebral disc prolapse.

Having back pain with radiation to lower limb for at least 4 weeks or more with straight leg raising test positive.

Exclusion criteria

Patient with infection, traumatic spine injuries, spinal tumors, spinal deformities and congenital spinal anomalies, bleeding disorders.

32 Patients (Group A).

32 Patients (Group B).

Rationale for selected sample size

Sample size

Formula Using Mean difference

n 1 = n 2 = 2 \frac{{(Z_{α} + Z_{β})}^{2} σ^{2}}{{(δ)}^{2}}

Z_{α} = 1.96

α = TypeIerrorat 5 % at both sides two tailed

Z_{β} = 0.84 = Power at 80 %

$σ = std . dev =$ Pooled std. deviation = (1.2 +2)/2 =1.5

Primary Variable VAS (Visual Analogue scale) =

Mean Before = 7.1, Mean after = 1.8

Mean difference = 7.1 - 1.8 = 5.3 at 20 % superiority δ = (5.3 * 20) = 1.06

Sample size N = n 1 = n 2 = 2 \frac{{(1.96 + 0.84)}^{2} {1.5}^{2}}{{(1.06)}^{2}} = 32 per group

Potential participants of the study coming to the orthopedics OPD will be explained in detail about their condition its progression and all complications. They will be explained about these conservative treatment option and they will be assured that there will be strong rapport between the investigating team and the participants. In addition, customized care, including listening to the participant's problems, addressing their concerns and allowing them to contact investigators at any time of the day would be ensured for promoting participant retention and complete follow-up

Statistical analysis

Microsoft Excel, SSPS tests, analytical tests like the chi-square test and the Student's t-test will be performed. P 0.05 will be used as the level of significance for both primary and secondary outcomes in all statistical analyses. The study does not have any subgroups, hence the subgroup analysis will not be performed.

Interim analyses

Patients will be assessed on the basis of Visual analogue scale, Oswestry disability questionnaire score and Straight leg raising test scores one hour post procedure, after 3 weeks and 3 months and results will be documented for final analysis.

Procedure

All adult patients with low back pain coming to the OPD of the Department of Orthopedics at Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi, Wardha will be recruited if they satisfy the criteria. After explaining about the procedure, written informed consent will be signed. Prior to the procedure patients will be investigated with Complete Blood Count, Erythrocyte sedimentation rate, coagulation profile, blood sugar level, X-Ray anteroposterior and lateral view of Lumbosacral spine. Patients will be kept nill per oral 6 hours prior to the procedure. Oswestry disability questionnaire score, Visual Analogue Scale (VAS) score, SLRT before the procedure will be documented. Patients will be divided via computer generated random numbers using block randomization process into two groups, of 32 patients in each group. Mechanism of implementing the allocation sequence will be sequentially numbered, opaque, sealed envelopes. The principal investigator will generate the allocation sequence, will enrol participants, and will assign participants to interventions.

Under strict aseptic precautions, Group A will be receive a single injection of 1.5 ml of methylprednisolone and 1.5 ml of 2% lidocaine with 0.5 ml of saline at the affected lumbar intervertebral disc level.

In comparison, under strict aseptic precautions, Group B will receive a single injection of 3 ml autologous Platelet rich plasma, which will be prepared under the sterile condition. About 20 ml of the patient's blood will be taken, from median cubital vein which will be centrifuged to prepare 3 ml of platelet-rich plasma. 3 ml autologous P.R.P. will be administered under strict aseptic precautions in the epidural space via an interlaminar approach with an 18G needle.

Preparation of PRP

This standard double spin method where 20 ml of blood is withdrawn from patient which is then transferred to 4 sterile sodium citrate vials each. These vials will be centrifuged at 2000 rpm for 15 minutes. Plasma will collect in the upper half of the test tube, while RBCs will settle in the lower part. Plasma is drawn out, collected in a different test tube, and centrifuged once more for 10 minutes at 1200 rpm. The platelet-poor plasma (PPP) in the upper buffy coat and the platelet-rich plasma (PRP) in the lower 2-4 mL layer of the plasma further separate. The simple noncooled REMI R-8C model centrifuge machine is used. The process is performed under sterile precaution at a room temperature of 24°C. This autologous PRP is utilized as the standard regenerative biological product.

Outcome measures

All analgesics will be stopped, including NSAIDs, 2 weeks before starting the study. After the procedure, the hemodynamic status including blood pressure, heart rate, oxygen saturation and temperature of the patient will be monitored and recorded every 10 minutes for half an hour and patients will also be monitored for any complications. Patients will be evaluated after 1 hour post procedure, and will be discharged with advice to avoid excessive foreword bending, lifting heavy weights, or walking for prolonged duration, and told to follow up at 3 weeks and 3 months. VAS score (Table 1), MODQ (Table 2), and SLRT (Table 3) were noted at all times.

Table 1. Visual analogue scale (VAS) score.

patient no	pre procedure	After 1 hour	on follow-up 3 weeks	on follow-up 3 months

Table 2. Oswestry disability questionnaire score.

patient no	pre procedure	After 1 hour	on follow-up 3 weeks	on follow-up 3 months

Table 3. Straight leg raising test scores.

patient no	pre procedure	After 1 hour	on follow-up 3 weeks	on follow-up 3 months

Ancillary and post trial care will be as follows, Post procedure patient will be kept inside the OT for 30 minutes for monitoring hemodynamic parameters including pulse rate, blood pressure, SP02 and then patient will be shifted to post op ICU to be observed for any complications including anaphylaxis, arrhythmia, hypotension or headache. There will be no special criteria for discontinuing or modifying allocated interventions. Strategies to improve adherence to interventions will include patient education verbally during each follow ups and reminder programs through phone calls. The participant timeline will be 18 July 2022 to 18 May 2024. Sequence generation will be done with Computer-generated random numbers. On-site computer system will be used as allocation concealment mechanism. The investigator will generate the allocation sequence, will handle participant enrolment and intervention assignment. Trial participants, outcome assessors, and data analysts will undergo blinding. In the event of an emergency requiring unblinding, the assignment will be determined through data analysis using randomized number spreadsheets. This process, devoid of human involvement, remains entirely concealed from both study investigators and potential participants until the assignment of the study arm.

Data management

Patients data will be collected manually after clinical assessments of each participant using VAS score, MODQ and SLTR and will be documented manually before the intervention, 1 hour post procedure and 3 weeks and 3 months post procedure. A strong rapport will be build between the investigating team and the participants. In addition, customized care, including listening to the participant's problems, addressing their concerns and allowing them to contact investigators at any time of the day would be ensured for promoting participant retention and complete follow-up. Electronic data management will be done; the primary investigator will collect the data and will enter the data into the password protected database for screening and randomization purposes which can by access only by the principal investigator.

Monitoring

The Data Monitoring Committee (DMC) will consist of the institute's research lead and the department's research lead. In the event of adverse events or unintended consequences related to trial interventions or conduct, data collection, analysis, and immediate reporting will occur. A monthly review of the conducted trial will be conducted by the project management team. The trial steering group and the independent committee responsible for data monitoring and ethical considerations will convene to review and oversee the trial's progress until its conclusion.

Dissemination

The findings of this study will be made available to the scientific community through publication in peer reviewed journals.

Study status

Study yet to be started.

Discussion/conclusion

The main aim of this observational study done in Jawaharlal Nehru Medical College is to compare the efficacy of epidural PRP and epidural steroids in low back pain. As there is an increase in the incidence and prevalence of low back pain and its management options,¹² it is essential to analyze and understand the outcome of low back pain managed with infiltration of epidural PRP and steroid and compare their efficacy.

Data availability

Underlying data

No data are associated with this article.

Reporting guidelines

Zenodo: SPIRIT checklist for ‘Randomised control trial of epidural platelet rich plasma versus epidural steroids for low back pain’. https://doi.org/10.5281/zenodo.8192167.¹¹

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Acknowledgements

The writer wishes to express gratitude to the personnel at the Department of Orthopedics in JNMC, AVBRH, Sawangi, Wardha, India for their assistance.

References

1. Wami SD, Abere G, Dessie A, et al.: Work-related risk factors and the prevalence of low back pain among low wage workers: results from a cross-sectional study. BMC Public Health. 2019); 19: 1072. PubMed Abstract | Publisher Full Text | Free Full Text
2. Kahere M, Ngcamphalala C, Östensson E, et al.: The economic burden of low back pain in KwaZulu-Natal, South Africa: A prevalence-based cost-of-illness analysis from the healthcare provider's perspective. PLoS One. 2022; 17(10): e0263204. Published 2022 Oct 13. PubMed Abstract | Publisher Full Text | Free Full Text
3. Yang H, Liu H, Li Z, et al.: Low back pain associated with lumbar disc herniation: role of moderately degenerative disc and annulus fibrous tears. Int. J. Clin. Exp. Med. 2015 Feb 15; 8(2): 1634–1644. PubMed Abstract | Free Full Text
4. Donnally CJ III, Hanna A, Varacallo M: Lumbar Degenerative Disk Disease. [Updated 2023 Aug 4]. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023 Jan. Reference Source
5. Kumar M: Epidemiology, pathophysiology and symptomatic treatment of sciatica: A review. nt. J. Pharm. Bio. Arch. 2011; 2.
6. Jordan J, Konstantinou K, O’Dowd J: Herniated lumbar disc. BMJ Clin. Evid. 2009; 2009: 1118.
7. Bhatia R, Chopra G: Efficacy of Platelet Rich Plasma via Lumbar Epidural Route in Chronic Prolapsed Intervertebral Disc Patients-A Pilot Study. J. Clin. Diagn. Res. 2016; 10(9): UC05-UC07. PubMed Abstract | Publisher Full Text | Free Full Text
8. Akeda K, et al.: Intradiscal injection of autologous serum isolated from platelet-rich-plasma for the treatment of discogenic low back pain: preliminary prospective clinical trial: GP141. Spine Journal Meeting Abstracts. LWW. 2011.
9. Bodor M, Toy A, Aufiero D: Disc regeneration with platelets and growth factors. Platelet-rich plasma: regenerative medicine: sports medicine, orthopedic, and recovery of musculoskeletal injuries. Berlin, Heidelberg: Springer Berlin Heidelberg; 2013; 265–279.
10. Patel K, Chopra P, Upadhyayula S: Epidural Steroid Injections. [Updated 2023 Jul 3]. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023 Jan. Reference Source
11. Adarsh JT: Randomised control trial of efficacy of epidural Platelet rich plasma v/s epidural steroids in low back pain (Version v1). Zenodo. 2023. Publisher Full Text
12. Andersson GB: Epidemiological features of chronic low-back pain. Lancet. 1999; 354(9178): 581–585. Publisher Full Text

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Version 1

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Author details Author details

¹ Department of orthopaedics, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India
² Department of orthopedics, Datta Meghe Institute of Higher Education and Research, wardha, Maharashtra, 442001, India

Adarsh Jayasoorya T.
Roles: Data Curation, Formal Analysis, Investigation, Methodology, Resources, Software, Supervision, Visualization

Nitin Samal
Roles: Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

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Published: 26 Sep 2023, 12:1221

https://doi.org/10.12688/f1000research.139399.1

Copyright

© 2023 Jayasoorya T. A and Samal N. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Jayasoorya T. A and Samal N. Randomised control trial of epidural platelet rich plasma versus epidural steroids for low back pain [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:1221 (https://doi.org/10.12688/f1000research.139399.1)

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Open Peer Review

Version 1

VERSION 1

PUBLISHED 26 Sep 2023

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Reviewer Report 02 Apr 2024

King Hei Stanley Lam, The Hong Kong Institute of Musculoskeletal Medicine & Department of Family Medicine, The Chinese University of Hong Kong & Department of Family Medicine, The University of Hong Kong, Hong Kong, China

Approved with Reservations

https://doi.org/10.5256/f1000research.152671.r251035

This is a prospective RCT to compare the efficacy of epidural platelet rich plasma injection vs epidural steroids for low back pain.

It is good to see more doctors around the world are paying more attention to ... Continue reading

This is a prospective RCT to compare the efficacy of epidural platelet rich plasma injection vs epidural steroids for low back pain.

It is good to see more doctors around the world are paying more attention to the usage of PRP and other autograph biologics for treating disabilities due to chronic pain.

Major issue:

The blinding of the investigator and patients need to be elaborated and clearly defined. The protocol did not clearly state how would the patients be blinded; and it did not clearly describe how would the principal investigator and the assessors be blinded to the allocation. There is high chance the principal investigator cannot be blinded, which created a significant bias in the study.
Procedure:
1. Why choose a particular form of steroid, methylprednisolone when we can choose non-particular form of steroid e.g. dexamethasone? Any justification(s)?
2. What kind of needle, exactly, will be used for the steroid injection? Who will perform the procedure? What is(are) the experience of the interventionist(s)? What guidance will be used in the injection? Ultrasound or fluoroscope or CT? How to ensure the needle and injectate will be injected to the epidural space? How did you arrive at the protocol of 1.5ml steroid mixed with 1.5ml 2% lidocaine, please give a citation for this protocol.
3. Why a 18G needle (what brand, what kind? Bevel of non-beveled?) will be used for PRP interlaminar injection? From my nearly 20 years’ experience of using PRP, I have no difficulty of injecting PRP using a needle bigger than 23Guage, the resistance will be more using a 25Guage needle, but is still feasible. Using a needle like 23G or 22G, there should be free flow without any resistance. Using a 18Guage needle means more damage to the ligamentum flavum and the whole tract of the trajectory, there is more chance of side effects from this procedure which is in fact preventable by using a smaller needle, e.g. 23G or 22G, or even a 25G spinal needle.
4. What kind of system of PRP will be used? What brand/ which company? Have you checked the system and evaluate how many times from the baseline the system can concentrate with your listed procedures? What is the final concentration of the platelet, leukocytes and its differential, and red blood cells? Will the PRP be mixed with lidocaine? Please give a citation if you have. Same questions for steroid injection: Who will perform the procedure? What is(are) the experience of the interventionist(s)? What guidance will be used in the injection? Ultrasound or fluoroscope or CT? How to ensure the needle and injectate will be injected to the epidural space?
5. Is the PRP itself or PRP lysate going to be injected, and why in each of the situation?
6. Why post-procedure the patients need to be admitted to ICU? This procedure should not need ICU for post-procedure care.

Minor issues:

The way this manuscript be written need to be edited.

The abstract should not contain to detailed prevalence of the LBP. “Low back pain (LBP) struck 619 million people worldwide in 2020, and by 2050, it's predicted that there will be 843 million instances worldwide. 70 to 85% of people are predicted to suffer from LBP at some point of time in their lives. 90% of these people will experience multiple episodes, and an intervertebral disc prolapse accounts for a significant portion.” These should be moved to introduction.

Please list the abbreviation when the word first appears, then keep using the abbreviation in the following content. Abbreviations in abstract and main content should be abbreviated separately.

“We therefore aim to conduct a study to analyse the patient’s functional status and satisfaction after epidural platelet-rich plasma infiltration.” This statement, the aim should also contain: “pain relief”, not only the “functional status and satisfaction”. How will the satisfaction be assessed in this study? I cannot see definite data collection for this aspect.
“subacute LBA is defined as lasting between 6 weeks - 3 months”, the “LBA” here should be “LBP” right? Please be consistent in using the short-forms.
In Discussion/conclusion session:
“As there is an increase in the incidence and prevalence of low back pain and its management options,12” The conclusion should be drawn based on the results of your study, but not on the literature. This statement should be moved to introduction or your discussion and please separate discussion with conclusion. There should be one part in your discussion, there is NO TRUE control group in your study, which affects the validity of this study, or better think about the option of having a third group as true control group if you have not started the study.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Regenerative Injection Therapy, Pain Management and Pain Medicine, Musculoskeletal Medicine, Ultrasound and fluoroscopic-guided interventions. Dynamic ultrasound and -guided interventions of spine and nerves.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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02 Apr 2024 | for Version 1

King Hei Stanley Lam, The Hong Kong Institute of Musculoskeletal Medicine & Department of Family Medicine, The Chinese University of Hong Kong & Department of Family Medicine, The University of Hong Kong, Hong Kong, China

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Approved With Reservations

This is a prospective RCT to compare the efficacy of epidural platelet rich plasma injection vs epidural steroids for low back pain.

It is good to see more doctors around the world are paying more attention to the usage of PRP and other autograph biologics for treating disabilities due to chronic pain.

Major issue:

The blinding of the investigator and patients need to be elaborated and clearly defined. The protocol did not clearly state how would the patients be blinded; and it did not clearly describe how would the principal investigator and the assessors be blinded to the allocation. There is high chance the principal investigator cannot be blinded, which created a significant bias in the study.
Procedure:
1. Why choose a particular form of steroid, methylprednisolone when we can choose non-particular form of steroid e.g. dexamethasone? Any justification(s)?
2. What kind of needle, exactly, will be used for the steroid injection? Who will perform the procedure? What is(are) the experience of the interventionist(s)? What guidance will be used in the injection? Ultrasound or fluoroscope or CT? How to ensure the needle and injectate will be injected to the epidural space? How did you arrive at the protocol of 1.5ml steroid mixed with 1.5ml 2% lidocaine, please give a citation for this protocol.
3. Why a 18G needle (what brand, what kind? Bevel of non-beveled?) will be used for PRP interlaminar injection? From my nearly 20 years’ experience of using PRP, I have no difficulty of injecting PRP using a needle bigger than 23Guage, the resistance will be more using a 25Guage needle, but is still feasible. Using a needle like 23G or 22G, there should be free flow without any resistance. Using a 18Guage needle means more damage to the ligamentum flavum and the whole tract of the trajectory, there is more chance of side effects from this procedure which is in fact preventable by using a smaller needle, e.g. 23G or 22G, or even a 25G spinal needle.
4. What kind of system of PRP will be used? What brand/ which company? Have you checked the system and evaluate how many times from the baseline the system can concentrate with your listed procedures? What is the final concentration of the platelet, leukocytes and its differential, and red blood cells? Will the PRP be mixed with lidocaine? Please give a citation if you have. Same questions for steroid injection: Who will perform the procedure? What is(are) the experience of the interventionist(s)? What guidance will be used in the injection? Ultrasound or fluoroscope or CT? How to ensure the needle and injectate will be injected to the epidural space?
5. Is the PRP itself or PRP lysate going to be injected, and why in each of the situation?
6. Why post-procedure the patients need to be admitted to ICU? This procedure should not need ICU for post-procedure care.

Minor issues:

The way this manuscript be written need to be edited.

The abstract should not contain to detailed prevalence of the LBP. “Low back pain (LBP) struck 619 million people worldwide in 2020, and by 2050, it's predicted that there will be 843 million instances worldwide. 70 to 85% of people are predicted to suffer from LBP at some point of time in their lives. 90% of these people will experience multiple episodes, and an intervertebral disc prolapse accounts for a significant portion.” These should be moved to introduction.

Please list the abbreviation when the word first appears, then keep using the abbreviation in the following content. Abbreviations in abstract and main content should be abbreviated separately.

“We therefore aim to conduct a study to analyse the patient’s functional status and satisfaction after epidural platelet-rich plasma infiltration.” This statement, the aim should also contain: “pain relief”, not only the “functional status and satisfaction”. How will the satisfaction be assessed in this study? I cannot see definite data collection for this aspect.
“subacute LBA is defined as lasting between 6 weeks - 3 months”, the “LBA” here should be “LBP” right? Please be consistent in using the short-forms.
In Discussion/conclusion session:
“As there is an increase in the incidence and prevalence of low back pain and its management options,12” The conclusion should be drawn based on the results of your study, but not on the literature. This statement should be moved to introduction or your discussion and please separate discussion with conclusion. There should be one part in your discussion, there is NO TRUE control group in your study, which affects the validity of this study, or better think about the option of having a third group as true control group if you have not started the study.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Regenerative Injection Therapy, Pain Management and Pain Medicine, Musculoskeletal Medicine, Ultrasound and fluoroscopic-guided interventions. Dynamic ultrasound and -guided interventions of spine and nerves.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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[1] 1. Wami SD, Abere G, Dessie A, et al.: Work-related risk factors and the prevalence of low back pain among low wage workers: results from a cross-sectional study. BMC Public Health. 2019); 19: 1072. PubMed Abstract | Publisher Full Text | Free Full Text

[2] 2. Kahere M, Ngcamphalala C, Östensson E, et al.: The economic burden of low back pain in KwaZulu-Natal, South Africa: A prevalence-based cost-of-illness analysis from the healthcare provider's perspective. PLoS One. 2022; 17(10): e0263204. Published 2022 Oct 13. PubMed Abstract | Publisher Full Text | Free Full Text

[3] 3. Yang H, Liu H, Li Z, et al.: Low back pain associated with lumbar disc herniation: role of moderately degenerative disc and annulus fibrous tears. Int. J. Clin. Exp. Med. 2015 Feb 15; 8(2): 1634–1644. PubMed Abstract | Free Full Text

[4] 4. Donnally CJ III, Hanna A, Varacallo M: Lumbar Degenerative Disk Disease. [Updated 2023 Aug 4]. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023 Jan. Reference Source

[5] 5. Kumar M: Epidemiology, pathophysiology and symptomatic treatment of sciatica: A review. nt. J. Pharm. Bio. Arch. 2011; 2.

[6] 6. Jordan J, Konstantinou K, O’Dowd J: Herniated lumbar disc. BMJ Clin. Evid. 2009; 2009: 1118.

[7] 7. Bhatia R, Chopra G: Efficacy of Platelet Rich Plasma via Lumbar Epidural Route in Chronic Prolapsed Intervertebral Disc Patients-A Pilot Study. J. Clin. Diagn. Res. 2016; 10(9): UC05-UC07. PubMed Abstract | Publisher Full Text | Free Full Text

[8] 8. Akeda K, et al.: Intradiscal injection of autologous serum isolated from platelet-rich-plasma for the treatment of discogenic low back pain: preliminary prospective clinical trial: GP141. Spine Journal Meeting Abstracts. LWW. 2011.

[9] 9. Bodor M, Toy A, Aufiero D: Disc regeneration with platelets and growth factors. Platelet-rich plasma: regenerative medicine: sports medicine, orthopedic, and recovery of musculoskeletal injuries. Berlin, Heidelberg: Springer Berlin Heidelberg; 2013; 265–279.

[10] 10. Patel K, Chopra P, Upadhyayula S: Epidural Steroid Injections. [Updated 2023 Jul 3]. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023 Jan. Reference Source

[11] 11. Adarsh JT: Randomised control trial of efficacy of epidural Platelet rich plasma v/s epidural steroids in low back pain (Version v1). Zenodo. 2023. Publisher Full Text

[12] 12. Andersson GB: Epidemiological features of chronic low-back pain. Lancet. 1999; 354(9178): 581–585. Publisher Full Text

Randomised control trial of epidural platelet rich plasma versus epidural steroids for low back pain

Abstract

Keywords

Introduction

Scope

Objectives

Protocol

Study design

Figure 1. Flow chart showing study design.

Ethical considerations

Participants

Inclusion criteria

Exclusion criteria

Rationale for selected sample size

Statistical analysis

Interim analyses

Procedure

Preparation of PRP

Outcome measures

Table 1. Visual analogue scale (VAS) score.

Table 2. Oswestry disability questionnaire score.

Table 3. Straight leg raising test scores.

Data management

Monitoring

Dissemination

Study status

Discussion/conclusion

Data availability

Underlying data

Reporting guidelines

Acknowledgements

References

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