Treatment of acute sciatica with transforaminal epidural corticosteroids and local anesthetic: design of a randomized controlled trial

Meulen, B. C. ter; Maas, Esther T.; Vyas, Amrita; Vegt, Marinus van der; Priester, Koo de; Boer, Michiel R. de; Tulder, Maurits W. van; Weinstein, Henry C.; Ostelo, Raymond

doi:10.1186/s12891-017-1571-8

Cited by 15 publications

(29 citation statements)

References 41 publications

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“…Current therapies include nonsurgical and surgical methods. The nonsurgical treatments include conservative management and invasive treatments [ 3 , 4 ]. For the conservative management, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, muscle relaxants, and steroidal drugs are commonly used among others.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness and Safety of Acupotomy for Lumbar Disc Herniation: A Randomized, Assessor-Blinded, Controlled Pilot Study

Kim

Kwon

et al. 2018

Evidence-Based Complementary and Alternative Medicine

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Objective Patients with lumbar disc herniation (LDH) suffer from pain, physical disabilities, and low quality of life. This study was designed to evaluate the effectiveness and safety of acupotomy in patients with LDH. Method Fifty participants with LDH were recruited to this randomized, assessor-blinded, controlled study and randomly assigned to the acupotomy (n = 25) or manual acupuncture (n = 25) group. The acupotomy group received acupotomy four times in 2 weeks, while the manual acupuncture group received manual acupuncture six times in 2 weeks. The follow-up visit was planned in the 4th week (i.e., 2 weeks after the final intervention). The primary outcome was the change in the Visual Analogue Scale (VAS) at follow-up. The changes in the Oswestry Disability Index (ODI), Modified-Modified Schober Test (MMST), and EuroQol Five Dimensions (EQ-5D) questionnaire were also evaluated. An intention-to-treat analysis was applied and adverse events were recorded. Results The acupotomy group showed significant changes in VAS, ODI, and EQ-5D after intervention. VAS and ODI in the 4th week were lower in the acupotomy than in the manual acupuncture group. The acupotomy group showed consistent changes in VAS and ODI in the 1st, 2nd, and 4th week. No serious adverse event was reported in the acupotomy group. Conclusion This study suggests greater therapeutic effects of acupotomy on relieving pain and improving the functional disability associated with LDH than those observed with manual acupuncture.

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Section: Introductionmentioning

confidence: 99%

Effectiveness and Safety of Acupotomy for Lumbar Disc Herniation: A Randomized, Assessor-Blinded, Controlled Pilot Study

Kim

Kwon

et al. 2018

Evidence-Based Complementary and Alternative Medicine

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“…Therefore, it is difficult to regard that the lack of efficacy could have been overlooked throughout several years by so many clinicians 28 . There is controversy about the ability of ECI to reduce the need for operation in patients with symptoms that are severe enough to be considered for surgical intervention 1,28 . Although the treatment of sciatica with ECIs is by no mean a permanent therapy and their effects decrease with time.…”

Section: Discussionmentioning

confidence: 99%

“…Sciatica describes health condition characterized by neuropathic pain with tingling or pricking sensation going down the leg from the lower back. It could be acute (less than 4 weeks), subacute (4-12 weeks) or chronic (more than 3 months) 1,2 . In most cases, the pain resolves spontaneously by using medication and physical therapy; however, the condition tends to become chronic and intractable beside socio-economic troubles as disability and absence from work among working population 3,4 .…”

Section: Introductionmentioning

confidence: 99%

Treatment of Sciatica by Interlaminar Epidural Corticosteroid Injections in Mosul City

samman¹,

asaady²

2020

Int. Res. J. Pharm.

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Objective: This study is conducted to evaluate the effectiveness and safety of ECIs in cases of sciatica in Mosul city with the aim of pain alleviation and improving physical performance. Methods: This study was conducted at Al-Salam Teaching Hospital. Patients were well informed of ECIs therapeutic profile. Enrolled patients have sciatic symptoms for at least 3 months prior to the study, inadequately responded to conservative therapy. Patients received a mixture of Methylprednisolone injection 80mg along with Normal saline plus Bupivacaine injection. Patients assessment for lower back pain and radiculopathy on basis of NRS score. The results were categorized as excellent, moderate and poor. Results: Fifty-two patients met the criteria for inclusion, 45 were males and 7 females. Their ages 25-46 years. The disease duration was between 2 months to 4 years. The first symptoms at presentation were pain (100%), paresthesia (25%), radiculopathy (53%), claudication (13%) and limitation in daily activity (46%). Forty-five patients received 1 injection, 3 patients received 2 and 4 received 3 injections. Eighty seven percent of the participants achieved a statistically significant decline in NRS as compared to baseline (P < 0.001). Mild to moderate side effects were developed by 23% of patients immediately after injection. Excellent results were noticed in 52%, moderate in 40% and poor results reported in 8% of cases. Conclusion: ECI is extremely good option for patients with sciatica who failed to respond to conservative therapy. It is safe and effective for patients unfit for surgery, spared patient from surgery, decreases analgesic intake and allows patient to return to work early.

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“…On March 6, 2014, the protocol was registered at the Dutch Trial Register (number NTR 4457). On August 20, 2015, the design of the STAR trial was approved by the Medical research Ethics Committees United, Nieuwegein, The Netherlands (registration number NL 45805.100.15) and the study protocol has been published elsewhere [ 8 ].…”

Section: Study Overviewmentioning

confidence: 99%

STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan

Meulen

Dongen

Vegt

et al. 2021

Trials

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Background Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However, their safety, effectiveness, and cost-effectiveness are still a matter of debate. This a priori statistical analysis plan describes the methodology of the analysis for the STAR trial that assesses the (cost-)effectiveness of TESI during the acute stage of sciatica (< 8 weeks). Methods The STAR trial is a multicentre, randomized controlled, prospective trial (RCT) investigating the (cost-)effectiveness of TESI by making a three-group comparison among patients with acute sciatica due to a herniated lumbar disc (< 8 weeks): (1) TESI combined with levobupivacaine added to oral pain medication (intervention group 1) versus oral pain medication alone (control group), (2) intervention group 1 versus transforaminal epidural injection with levobupivacaine and saline solution added to oral pain medication (intervention group 2), and (3) intervention group 2 versus control group. Co-primary outcomes were physical functioning (Roland Morris Disability Questionnaire), pain intensity (10-point numerical rating scale), and global perceived recovery (7-point Likert scale, dichotomized into ‘recovered’ and ‘not recovered’). For all three comparisons, we defined the following minimal clinically relevant between-group differences: two points for pain intensity (range 0–10), four points for physical functioning (range 0–24) and a 20% difference in recovery rate. Secondary outcomes are health-related quality of life (EQ-5D-5L) and patient satisfaction (7-point Likert scale) and surgery rate. We also collected resource use data to perform an economic evaluation. Analyses will be conducted by intention-to-treat with p < 0.05 (two-tailed) for all three comparisons. Effects will be estimated using mixed models by maximum likelihood. For each comparison, mean differences, or difference in proportions, between groups will be tested per time point and an overall mean difference, or difference in proportions, between groups during the complete duration of follow-up (6 months) will be estimated. In the economic evaluation, Multivariate Imputation by Chained Equations will be used to handle missing data. Cost and effect differences will be estimated using seemingly unrelated regression, and uncertainty will be estimated using bootstrapping techniques. Discussion This statistical analysis plan provides detailed information on the intended analysis of the STAR trial, which aims to deliver evidence about the (cost-)effectiveness of TESI during the acute phase of sciatica (< 8 weeks). Trial registration Dutch National trial register NTR4457 (6 March 2014)

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Treatment of acute sciatica with transforaminal epidural corticosteroids and local anesthetic: design of a randomized controlled trial

Cited by 15 publications

References 41 publications

Effectiveness and Safety of Acupotomy for Lumbar Disc Herniation: A Randomized, Assessor-Blinded, Controlled Pilot Study

Effectiveness and Safety of Acupotomy for Lumbar Disc Herniation: A Randomized, Assessor-Blinded, Controlled Pilot Study

Treatment of Sciatica by Interlaminar Epidural Corticosteroid Injections in Mosul City

STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan

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